Scolaris Content Display Scolaris Content Display

Hipotermia por lesión cerebral traumática

Appendices

Appendix 1. Search strategies 2016 and 2017

The search strategies for the 2017 update were slightly modified because the search interfaces on some of the databases have changed since the last update in 2009, however the search terms remain unchanged.

The search of the clinical trials registers was not limited by date as the search terms used previously were not reported and it was unclear how the registers were searched, the search strings are now reported in full in this appendix.

Studies identified from searches to March 2016 have been incorporated in this review, a study identified from a pre‐publication search (1 June 2017) is presented in Studies awaiting classification.

Cochrane Injuries Group Specialised Register and Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library) Issue 6, 2017

#1MESH DESCRIPTOR Craniocerebral Trauma EXPLODE ALL TREES
#2MESH DESCRIPTOR Cerebrovascular Trauma EXPLODE ALL TREES
#3MESH DESCRIPTOR Brain Edema EXPLODE ALL TREES
#4((brain or cerebral or intracranial) near3 (oedema or edema or swell*)):TI,AB,KY
#5MESH DESCRIPTOR Glasgow Coma Scale EXPLODE ALL TREES
#6MESH DESCRIPTOR Glasgow Outcome Scale EXPLODE ALL TREES
#7MESH DESCRIPTOR Unconsciousness EXPLODE ALL TREES
#8(glasgow near3 (coma or outcome) near3 (score or scale)):TI,AB,KY
#9((Unconscious* or coma* or concuss* or 'persistent vegetative state') near3 (injur* or trauma* or damag* or wound* or fracture*)):TI,AB,KY
#10("Rancho Los Amigos Scale"):TI,AB,KY
#11((head or crani* or cerebr* or capitis or brain* or forebrain* or skull* or hemispher* or intra‐cran* or inter‐cran*) near3 (injur* or trauma* or damag* or wound* or fracture* or contusion*)):TI,AB,KY
#12(Diffuse near3 axonal near3 injur*):TI,AB,KY
#13((head or crani* or cerebr* or brain* or intra‐cran* or inter‐cran*) near3 (haematoma* or hematoma* or haemorrhag* or hemorrhag* or bleed* or pressure)):TI,AB,KY
#14(#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13)
#15MESH DESCRIPTOR Hypothermia, Induced EXPLODE ALL TREES
#16MESH DESCRIPTOR Cryotherapy EXPLODE ALL TREES
#17MESH DESCRIPTOR Body Temperature EXPLODE ALL TREES
#18(hypotherm* or normotherm* or cool* or cold* or temperature* or cryother* or cryogen* or cryotreat*):TI,AB,KY
#19(#15 OR #16 OR #17 OR #18)
#20#14 AND #19
#21* NOT INMEDLINE NOT INEMBASE
#22#20 AND #21

[The update search in June 2017 was not limited by line 21]

Ovid MEDLINE(R), Ovid MEDLINE(R) In‐Process & Other Non‐Indexed Citations, Ovid MEDLINE(R) Daily and Ovid OLDMEDLINE(R) to 1 June 2017

1. exp Craniocerebral Trauma/
2. exp Brain Edema/
3. exp Glasgow Coma Scale/
4. exp Glasgow Outcome Scale/
5. exp Unconsciousness/
6. exp Cerebrovascular Trauma/
7. ((head or crani$ or cerebr$ or capitis or brain$ or forebrain$ or skull$ or hemispher$ or intra‐cran$ or inter‐cran$) adj3 (injur$ or trauma$ or damag$ or wound$ or fracture$ or contusion$)).ab,ti.
8. ((head or crani$ or cerebr$ or brain$ or intra‐cran$ or inter‐cran$) adj3 (haematoma$ or hematoma$ or haemorrhag$ or hemorrhag$ or bleed$ or pressure)).ti,ab.
9. (Glasgow adj3 (coma or outcome) adj3 (scale$ or score$)).ab,ti.
10. "rancho los amigos scale".ti,ab.
11. ("diffuse axonal injury" or "diffuse axonal injuries").ti,ab.
12. ((brain or cerebral or intracranial) adj3 (oedema or edema or swell$)).ab,ti.
13. ((unconscious$ or coma$ or concuss$ or 'persistent vegetative state') adj3 (injur$ or trauma$ or damag$ or wound$ or fracture$)).ti,ab.
14. or/1‐13
15. exp Hypothermia, Induced/
16. exp Cryotherapy/
17. exp Body Temperature/
18. (hypotherm* or normotherm* or cool* or cold* or temperature* or cryother* or cryogen* or cryotreat*).ab,ti.
19. 18 or 16 or 17 or 15
20. 19 and 14
21. randomi?ed.ab,ti.
22. randomised controlled trial.pt.
23. controlled clinical trial.pt.
24. placebo.ab.
25. clinical trials as topic.sh.
26. randomly.ab.
27. trial.ti.
28. Comparative Study/
29. 21 or 22 or 23 or 24 or 25 or 26 or 27 or 28
30. (animals not (humans and animals)).sh.
31. 29 not 30
32. 20 and 31

Embase Classic + Embase (OvidSP)

1. exp Craniocerebral Trauma/
2. exp Brain Edema/
3. exp Glasgow Coma Scale/
4. exp Glasgow Outcome Scale/
5. exp Unconsciousness/
6. exp Cerebrovascular Trauma/
7. ((head or crani$ or cerebr$ or capitis or brain$ or forebrain$ or skull$ or hemispher$ or intra‐cran$ or inter‐cran$) adj3 (injur$ or trauma$ or damag$ or wound$ or fracture$ or contusion$)).ab,ti.
8. ((head or crani$ or cerebr$ or brain$ or intra‐cran$ or inter‐cran$) adj3 (haematoma$ or hematoma$ or haemorrhag$ or hemorrhag$ or bleed$ or pressure)).ti,ab.
9. (Glasgow adj3 (coma or outcome) adj3 (scale$ or score$)).ab,ti.
10. "rancho los amigos scale".ti,ab.
11. ("diffuse axonal injury" or "diffuse axonal injuries").ti,ab.
12. ((brain or cerebral or intracranial) adj3 (oedema or edema or swell$)).ab,ti.
13. ((unconscious$ or coma$ or concuss$ or 'persistent vegetative state') adj3 (injur$ or trauma$ or damag$ or wound$ or fracture$)).ti,ab.
14. or/1‐13
15. exp Hypothermia, Induced/
16. exp Cryotherapy/
17. exp Body Temperature/
18. (hypotherm* or normotherm* or cool* or cold* or temperature* or cryother* or cryogen* or cryotreat*).ab,ti.
19. 18 or 16 or 17 or 15
20. 19 and 14
21. exp Randomized Controlled Trial/
22. exp controlled clinical trial/
23. exp controlled study/
24. comparative study/
25. randomi?ed.ab,ti.
26. placebo.ab.
27. *Clinical Trial/
28. exp major clinical study/
29. randomly.ab.
30. (trial or study).ti.
31. 21 or 22 or 23 or 25 or 26 or 27 or 28 or 29 or 30
32. exp animal/ not (exp human/ and exp animal/)
33. 31 not 32
34. 20 and 33
35. limit 34 to exclude medline journals

In June 2017 a new Embase search was run which included relevant Emtree Subject Headings (as listed below).

Embase (1974 to 2017 Week 22)
1 randomised controlled trial/
2 controlled clinical trial/
3 randomi#ed.ti,ab,kw.
4 randomization/
5 placebo.ti,ab,kw.
6 placebo/
7 *Clinical Trial/
8 ((singl* or doubl* or trebl* or tripl*) adj3 (blind* or mask* or dummy)).ti,ab,kw.
9 double blind procedure/
10 (RCT or at random or (random* adj (assign* or allocat* or divid* or division or number))).ti,ab,kw.
11 trial.ti.
12 or/1‐11
13 ((animal or nonhuman) not (human and (animal or nonhuman))).de.
14 (12 not 13)
15 head injury/
16 exp brain injury/
17 cerebrovascular accident/
18 exp brain hemorrhage/
19 brain edema/
20 intracranial pressure/
21 brain perfusion/
22 exp brain injury assessment/
23 exp unconsciousness/
24 ((head or crani* or cerebr* or capitis or brain* or forebrain* or skull* or hemispher* or intra‐cran* or
intracran* or intra‐cereb* or intracereb*) adj3 (infarct* or injur* or trauma* or damag* or wound* or fracture* or contusion*)).ab,ti,kw.
25 ((head or crani* or cerebr* or brain* or intra‐cran* or intracran* or intra‐cereb* or intracereb*) adj3
(haematoma* or hematoma* or haemorrhag* or hemorrhag* or hernia* or bleed* or pressure or hypertension or oedema or edema or swell*)).ti,ab,kw.
26 (Glasgow adj3 (coma or outcome) adj3 (scale* or score*)).ab,ti,kw.
27 rancho los amigos scale.ti,ab,kw.
28 diffuse axonal injur*.ti,ab,kw.
29 ((unconscious* or coma* or concuss* or postconcuss* or 'persistent vegetative state') adj3 (injur* or trauma* or damag* or wound* or fracture*)).ti,ab,kw.
30 (subarachnoid h?emorrhage or tSAH).ti,ab,kw.
31 ((midbrain or mid brain) adj syndrome).ti,ab,kw.
32 (TBI or mTBI or sTBI).ti,ab,kw.
33 or/15‐32
34 (14 and 33)
35 exp induced hypothermia/
36 exp cryotherapy/
37 exp body temperature/
38 (hypotherm* or normotherm* or cool* or cold* or temperature* or cryother* or cryogen* or cryotreat*).ab,ti,kw.
39 or/35‐38
40 (34 and 39)
41 (2016* or 2017*).yr,dd.
42 (40 and 41)

PubMed (1 June 2017)

((((hypotherm*[Title/Abstract] OR normotherm*[Title/Abstract] OR cool*[Title/Abstract] OR cold*[Title/Abstract] OR temperature*[Title/Abstract] OR cryother*[Title/Abstract] OR cryogen*[Title/Abstract] OR cryotreat*[Title/Abstract])) OR ((("Hypothermia, Induced"[Mesh]) OR "Cryotherapy"[Mesh:NoExp]) OR "Body Temperature"[Mesh]))) AND (((((pubmednotmedline[sb] OR (pubstatusnihms OR pubstatuspmcsd AND publisher[sb])))) AND (((((((("Comparative Study"[Publication Type]) OR "Randomized Controlled Trial"[Publication Type]) OR "Controlled Clinical Trial"[Publication Type])) OR (((((((randomised[Title/Abstract]) OR randomised[Title/Abstract]) OR placebo[Title/Abstract]) OR randomly[Title/Abstract]) OR trial[Title/Abstract]) OR groups[Title/Abstract]) OR group[Title/Abstract])))) AND (((Craniocerebral Trauma [mh] OR Brain Edema [mh] OR Glasgow Coma Scale [mh] OR Glasgow Outcome Scale [mh] OR Unconsciousness [mh] OR Cerebrovascular Trauma [mh])) OR ((((injury*[Title/Abstract] OR injuries[Title/Abstract] OR trauma[Title/Abstract] OR damage[Title/Abstract] OR damaged[Title/Abstract] OR wound*[Title/Abstract] OR fracture*[Title/Abstract] OR contusion*[Title/Abstract] OR haematoma*[Title/Abstract] OR hematoma*[Title/Abstract] OR haemorrhag*[Title/Abstract] OR hemorrhag*[Title/Abstract] OR bleed*[Title/Abstract] OR pressure[Title/Abstract]))) AND (head[Title/Abstract] or cranial[Title/Abstract] or cerebral[Title/Abstract] or brain*[Title/Abstract] or intra‐cranial[Title/Abstract] or inter‐cranial[Title/Abstract]) AND (haematoma*[Title/Abstract] or hematoma*[Title/Abstract] or haemorrhag*[Title/Abstract] or hemorrhage*[Title/Abstract] or bleed*[Title/Abstract] or pressure[Title/Abstract]) OR (Glasgow[Title/Abstract] AND scale[Title/Abstract]) OR ("diffuse axonal injury"[Title/Abstract]) OR ("diffuse axonal injuries"[Title/Abstract]) OR ("persistent vegetative state"[Title/Abstract]) OR (unconscious*[Title/Abstract]) OR coma*[Title/Abstract] OR concuss*[Title/Abstract])))))

ISI Web of Science: Science Citation Index Expanded (SCI‐EXPANDED) and Conference Proceedings Citation Index‐Science (CPCI‐S) (1 June 2017)

# 9#8 AND #7 AND #6
# 8TS=(injury* OR injuries OR trauma OR damage OR damaged OR wound* OR fracture* OR contusion* OR haematoma* OR hematoma* OR haemorrhag* OR hemorrhag* OR bleed* OR pressure)
# 7TS=(hypotherm* OR normotherm* OR cool* OR cold* OR temperature* OR cryother* OR cryogen* OR cryotreat*)
# 6#5 AND #4
# 5TS=(human*)
# 4#3 OR #2 OR #1
# 3TS=((singl* OR doubl* OR trebl* OR tripl*) SAME (blind* OR mask*))
# 2TS=(controlled clinical trial OR controlled trial OR clinical trial OR placebo)
# 1TS=(randomised OR randomised OR randomly OR random order OR random sequence OR random allocation OR randomly allocated OR at random OR randomised controlled trial)

Clinicaltrials.gov (1 June 2017)
INFLECT EXACT "Interventional" [STUDY‐TYPES] AND ( injury* OR injuries OR trauma OR damage OR damaged OR wound* OR fracture* OR contusion* OR haematoma* OR hematoma* OR haemorrhag* OR hemorrhag* OR bleed* OR pressure ) [DISEASE] AND ( hypothermia OR normothermia OR cool* OR cold* OR temperature* OR cryotheraphy ) [TREATMENT]

WHO International Clinical Trials Registry Platform (1 June 2017)
Condition: (injury* OR injuries OR trauma OR damage OR damaged OR wound* OR fracture* OR contusion* OR haematoma* OR hematoma* OR haemorrhag* OR hemorrhag* OR bleed* OR pressure)
AND
Intervention: hypotherm* OR normotherm* OR cool* OR cold* OR temperature* OR cryother* OR cryogen* OR cryotreat*
Recruitment: ALL

ISRCTN Registry (21 March 2016)

Text search: (injury OR injuries OR trauma OR contusion OR haematoma OR hematoma OR haemorrhage OR hemorrhage OR bleed) AND (hypothermia OR normothermia OR cryother* OR cryogen* OR cryotreat*)

Appendix 2. Previous search strategies

2009 Search methods

  • Cochrane Injuries Group Specialised Register (12 Jan 2009);

  • CENTRAL (The Cochrane Library Issue 1, 2009);

  • MEDLINE (1950 to March 2009);

  • PubMed (searched 6 April 2009);

  • EMBASE (1980 to week 14, March 2009);

  • ISI Web of Science: Science Citation Index Expanded (SCI‐EXPANDED) 1970 to April 2009 and Conference Proceedings Citation Index‐Science (CPCI‐S) 1990 to 7 April 2009;

  • Controlled Trials metaRegister of trials (mRCT) http://www.controlled‐trials.com/mrct/ (12 January 2009);

  • Zetoc (12 January 2009).

Injuries Group's Specialised Register (searched 12 January 2009)
((injur* or trauma* or lesion* or damage* or wound* or oedema* or edema* or fracture* or contusion* or concus* or commotion* or pressur*) and (head or crani* or capitis or brain* or forebrain* or skull* or hemisphere or intracran* or orbit*)) and (hypotherm* or normotherm* or cool* or cold* or temperature* or cryother* or cryogen* or cryotreat*)

CENTRAL (The Cochrane Library 2009, Issue 1)
#1MeSH descriptor Craniocerebral Trauma explode all trees
#2MeSH descriptor Cerebrovascular Trauma explode all trees
#3MeSH descriptor Brain Edema explode all trees
#4(brain or cerebral or intracranial) near3 (oedema or edema or swell*)
#5MeSH descriptor Glasgow Coma Scale explode all trees
#6MeSH descriptor Glasgow Outcome Scale explode all trees
#7MeSH descriptor Unconsciousness explode all trees
#8glasgow near3 (coma or outcome) near3 (score or scale)
#9(Unconscious* or coma* or concuss* or 'persistent vegetative state') near 3 (injur* or trauma* or damag* or wound* or fracture*)
#10"Rancho Los Amigos Scale"
#11(head or crani* or cerebr* or capitis or brain* or forebrain* or skull* or hemispher* or intra‐cran* or inter‐cran*) near3 (injur* or trauma* or damag* or wound* or fracture* or contusion*)
#12Diffuse near3 axonal near3 injur*
#13(head or crani* or cerebr* or brain* or intra‐cran* or inter‐cran*) near3 (haematoma* or hematoma* or haemorrhag* or hemorrhag* or bleed* or pressure)
#14(#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13)
#15MeSH descriptor Hypothermia, Induced explode all trees
#16MeSH descriptor Cryotherapy explode all trees
#17MeSH descriptor Body Temperature explode all trees
#18hypotherm* or normotherm* or cool* or cold* or temperature* or cryother* or cryogen* or cryotreat*
#19(#15 OR #16 OR #17 OR #18)
#20(#14 AND #19)
#21neonat*
#22(#20 AND NOT #21)

MEDLINE (1966 to March week 4, 2009)
1.exp Craniocerebral Trauma/
2.exp Brain Edema/
3.exp Glasgow Coma Scale/
4.exp Glasgow Outcome Scale/
5.exp Unconsciousness/
6.exp Cerebrovascular Trauma/
7.((head or crani$ or cerebr$ or capitis or brain$ or forebrain$ or skull$ or hemispher$ or intra‐cran$ or inter‐cran$) adj3 (injur$ or trauma$ or damag$ or wound$ or fracture$ or contusion$)).ab,ti.
8.((head or crani$ or cerebr$ or brain$ or intra‐cran$ or inter‐cran$) adj3 (haematoma$ or hematoma$ or haemorrhag$ or hemorrhag$ or bleed$ or pressure)).ti,ab.
9.(Glasgow adj3 (coma or outcome) adj3 (scale$ or score$)).ab,ti.
10."rancho los amigos scale".ti,ab.
11.("diffuse axonal injury" or "diffuse axonal injuries").ti,ab.
12.((brain or cerebral or intracranial) adj3 (oedema or edema or swell$)).ab,ti.
13.((unconscious$ or coma$ or concuss$ or 'persistent vegetative state') adj3 (injur$ or trauma$ or damag$ or wound$ or fracture$)).ti,ab.
14.or/1‐13
15.(randomised or randomised or randomly or random order or random sequence or random allocation or randomly allocated or at random or controlled clinical trial$).tw,hw.
16.clinical trial.pt.
17.randomised controlled trial.pt.
18.15 or 16 or 17
19.exp models, animal/
20.exp Animals/
21.exp Animal Experimentation/
22.exp Disease Models, Animal/
23.exp Animals, Laboratory/
24.or/19‐23
25.Humans/
26.24 not 25
27.18 not 26
28.14 and 27
29.exp Hypothermia, Induced/
30.exp Cryotherapy/
31.exp Body Temperature/
32.(hypotherm* or normotherm* or cool* or cold* or temperature* or cryother* or cryogen* or cryotreat*).ab,ti.
33.or/29‐32
34.neonat*.ab,ti.
35.33 not 34
36.28 and 35

PubMed 6 April 2009 (last 90 days)
#1Craniocerebral Trauma [mh] OR Brain Edema [mh] OR Glasgow Coma Scale [mh] OR Glasgow Outcome Scale [mh] OR Unconsciousness [mh] OR Cerebrovascular Trauma [mh] OR ((head or cranial or cerebral or brain* or intra‐cranial or inter‐cranial) AND (haematoma* or hematoma* or haemorrhag* or hemorrhage* or bleed* or pressure)) OR (Glasgow AND scale) OR ("diffuse axonal injury" OR "diffuse axonal injuries") or ("persistent vegetative state") OR ((unconscious* OR coma* OR concuss*) AND (injury* OR injuries OR trauma OR damage OR damaged OR wound* OR fracture* OR contusion* OR haematoma* OR hematoma* OR haemorrhag* OR hemorrhag* OR bleed* OR pressure))
#2(randomised OR randomised OR randomly OR random order OR random sequence OR random allocation OR randomly allocated OR at random OR randomised controlled trial [pt] OR controlled clinical trial [pt] OR randomised controlled trials [mh]) NOT ((models, animal[mh] OR Animals[mh] OR Animal Experimentation[mh] OR Disease Models, Animal[mh] OR Animals, Laboratory[mh]) NOT (Humans[mh]))
#31 and 2
#4("Hypothermia, Induced"[Mesh] OR "Cryotherapy"[Mesh]) OR "Body Temperature"[Mesh]
#5hypotherm* or normotherm* or cool* or cold* or temperature* or cryother* or cryogen* or cryotreat* Field: Title/Abstract
#64 or 5
#7Neonat* Field: Title/Abstract
#86 not 7
#93 and 8

Embase 1980 to (week 14) March 2009
1.exp Brain Injury/
2.exp Brain Edema/
3.exp Glasgow Coma Scale/
4.exp Glasgow Outcome Scale/
5.exp Rancho Los Amigos Scale/
6.exp Unconsciousness/
7.((brain or cerebral or intracranial) adj3 (oedema or edema or swell$)).ab,ti.
8.((head or crani$ or cerebr$ or capitis or brain$ or forebrain$ or skull$ or hemispher$ or intra‐cran$ or inter‐cran$) adj3 (injur$ or trauma$ or damag$ or wound$ or fracture$ or contusion$)).ab,ti.
9.(Glasgow adj3 (coma or outcome) adj3 (scale$ or score$)).ab,ti.
10.Rancho Los Amigos Scale.ab,ti.
11.((unconscious$ or coma$ or concuss$ or 'persistent vegetative state') adj3 (injur$ or trauma$ or damag$ or wound$ or fracture$)).ti,ab.
12.Diffuse axonal injur$.ab,ti.
13.((head or crani$ or cerebr$ or brain$ or intra‐cran$ or inter‐cran$) adj3 (haematoma$ or hematoma$ or haemorrhag$ or hemorrhag$ or bleed$ or pressure)).ab,ti.
14.or/1‐13
15.exp animal model/
16.Animal Experiment/
17.exp ANIMAL/
18.exp Experimental Animal/
19.15 or 16 or 17 or 18
20.Human/
21.19 not 20
22.(randomised or randomised or randomly or random order or random sequence or random allocation or randomly allocated or at random or controlled clinical trial$).tw,hw.
23.exp clinical trial/
24.22 or 23
25.24 not 21
26.14 and 25
27.exp INDUCED HYPOTHERMIA/
28.exp PROFOUND INDUCED HYPOTHERMIA/
29.exp CRYOTHERAPY/
30.exp Body Temperature/
31.(hypotherm* or normotherm* or cool* or cold* or temperature* or cryother* or cryogen* or cryotreat*).ab,ti.
32.27 or 28 or 29 or 30 or 31
33.neonat*.ab,ti.
34.32 not 33
35.26 and 34

Controlled Trials metaRegister of trials (mRCT) http://www.controlled‐trials.com/mrct/ (searched 12 January 2009)
((injur* or trauma* or damage*) and (head or crani* or brain* or forebrain* or intracran*)) and (hypotherm* or normotherm* or cool* or cold* or temperature* or cryother*)

ISI Web of Science: Science Citation Index Expanded (SCI‐EXPANDED) 1970 to April 2009 and Conference Proceedings Citation Index‐ Science (CPCI‐S) 1990 to 7 April 2009
1.Topic=((injur* or trauma* or lesion* or damage* or wound* or oedema* or edema* or fracture* or contusion* or concus* or commotion* or pressur*) AND (head or crani* or capitis or brain* or forebrain* or skull* or hemisphere or intracran* or orbit*)) AND Topic=(hypotherm* or normotherm* or cool* or cold* or temperature* or cryother* or cryogen* or cryotreat*) NOT Topic=(neonat*)
2.Topic=(randomised OR randomised OR randomly OR random order OR random sequence OR random allocation OR randomly allocated OR at random OR randomised controlled trial OR controlled clinical trial OR randomised controlled trials OR controlled trial OR clinical trial) NOT Topic=(animal model* OR Animals OR Animal Experiment* OR Laboratory animals* or animal disease model*)
3.1 and 2

ZETOC (searched 12 January 2009)
Hypotherm* head injur* trial*
Hypotherm* head injur* random*
Hypotherm* head injur* control*

Hypotherm* brain injur* trial*
Hypotherm* brain injur* random*
Hypotherm* brain injur* control*

Hypotherm* head trauma* trial*
Hypotherm* head trauma* random*
Hypotherm* head trauma* control*

Hypotherm* brain trauma* trial*
Hypotherm* brain trauma* random*
Hypotherm* brain trauma* control*

The following search strategy was used for the initial search in 1998:
The Specialist Trials Register for the Injuries Group was searched in May 1998 for any relevant randomised trials relating to temperature control using the search terms: hypotherm* OR normotherm* OR cool* OR cold* OR temperature.

The search strategy for the register is primarily an electronic search of both MEDLINE and CENTRAL, supplemented by various hand‐searching activities listed in the Group details. This was supplemented by a comprehensive EMBASE search, also performed in May 1998 as follows, to identify all potential RCTs involving human head injury and temperature control from 1980 onwards:
001 exp head injury/
002 pneumocephalus/
003 cerebrospinal fluid/
004 otorrhea/
005 exp skull fracture/
006 exp spine fracture/
007 Cerebrospinal Fluid Rhinorrhea/
008 exp asphyxia/
009 exp spine injury/
010 helmet/
011 brain protection/
012 brain edema/
013 exp brain hemorrhage/
014 brain hypoxia/
015 coma/
016 persistent vegetative state/
017 Traumatic Epilepsy/
018 or/1‐17
019 (head or brain or cerebr$ or skull or crani$ or spin$).tw.
020 (wound$ or injur$ or trauma$ or oedema$ or edema$).tw.
021 damage$.tw.
022 20 or 21
023 19 and 22
024 18 or 23
025 human/
026 "888".tg.
027 25 or 26
028 Nonhuman/
029 "777".tg.
030 28 or 29
031 27 and 30
032 30 not 31
033 clinical trial/
034 Multicenter Study/
035 phase 2 clinical trial/
036 phase 3 clinical trial/
037 Phase 4 Clinical Trial/
038 Randomized Controlled Trial/
039 controlled study/
040 meta analysis/
041 crossover procedure/
042 double blind procedure/
043 Single Blind Procedure/
044 randomization/
045 Major Clinical Study/
046 placebo/
047 drug comparison/
048 clinical study/
049 "0197".tg.
050 "0150".tg.
051 "03738".dc.
052 (clin$ adj25 trial$).tw.
053 ((singl$ or doubl$ or tripl$ or trebl$) adj25 (blind$ or mask$)).tw.
054 placebo$.tw.
055 random$.tw.
056 control$.tw.
057 or/33‐56
058 24 not 32
059 Induced Hypothermia/
060 Profound Induced Hypothermia/
061 exp temperature/
062 exp low temperature procedures/
063 cold/
064 cold air/
065 cold exposure/
066 (hypotherm$ or normotherm$ or cool$ or cold$ or temperature$).tw.
067 or/59‐66
068 58 and 67
069 68 and 57

The searches were supplemented by further handsearching of conference proceedings and abstracts as follows:

  • International Conference on Recent Advances in Neurotraumatology, Italy 1996

  • 2nd International Neurotrauma Symposium, Glasgow 1993

  • 3rd International Neurotrauma Symposium, Toronto 1995

  • 4th International Neurotrauma Symposium, Seoul 1997

  • 27th Meeting of the Society for Critical Care Medicine, USA 1998

  • 10th International Symposium on Intracranial Pressure, USA 1997

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all 37 included studies.
Figuras y tablas -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all 37 included studies.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.Note: blank spaces in risk of bias table indicate that the relevant outcome was not reported by study authors
Figuras y tablas -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Note: blank spaces in risk of bias table indicate that the relevant outcome was not reported by study authors

Funnel plot of comparison 1: Therapeutic cooling versus no cooling, outcome: 1.1 Mortality.
Figuras y tablas -
Figure 4

Funnel plot of comparison 1: Therapeutic cooling versus no cooling, outcome: 1.1 Mortality.

Comparison 1 Therapeutic cooling versus no cooling, Outcome 1 Mortality.
Figuras y tablas -
Analysis 1.1

Comparison 1 Therapeutic cooling versus no cooling, Outcome 1 Mortality.

Comparison 1 Therapeutic cooling versus no cooling, Outcome 2 Unfavourable outcome.
Figuras y tablas -
Analysis 1.2

Comparison 1 Therapeutic cooling versus no cooling, Outcome 2 Unfavourable outcome.

Comparison 1 Therapeutic cooling versus no cooling, Outcome 3 Pneumonia.
Figuras y tablas -
Analysis 1.3

Comparison 1 Therapeutic cooling versus no cooling, Outcome 3 Pneumonia.

Comparison 2 Therapeutic cooling versus no cooling: by duration, Outcome 1 Mortality.
Figuras y tablas -
Analysis 2.1

Comparison 2 Therapeutic cooling versus no cooling: by duration, Outcome 1 Mortality.

Comparison 2 Therapeutic cooling versus no cooling: by duration, Outcome 2 Unfavourable outcome.
Figuras y tablas -
Analysis 2.2

Comparison 2 Therapeutic cooling versus no cooling: by duration, Outcome 2 Unfavourable outcome.

Comparison 2 Therapeutic cooling versus no cooling: by duration, Outcome 3 Pneumonia.
Figuras y tablas -
Analysis 2.3

Comparison 2 Therapeutic cooling versus no cooling: by duration, Outcome 3 Pneumonia.

Comparison 3 Therapeutic cooling versus no cooling: by length of follow‐up, Outcome 1 Mortality.
Figuras y tablas -
Analysis 3.1

Comparison 3 Therapeutic cooling versus no cooling: by length of follow‐up, Outcome 1 Mortality.

Comparison 3 Therapeutic cooling versus no cooling: by length of follow‐up, Outcome 2 Unfavourable outcome.
Figuras y tablas -
Analysis 3.2

Comparison 3 Therapeutic cooling versus no cooling: by length of follow‐up, Outcome 2 Unfavourable outcome.

Summary of findings for the main comparison. Hypothermia for traumatic brain injury

Hypothermia for traumatic brain injury

Patient or population: patients with traumatic brain injury
Settings: hospitals; in Australia, Canada, China, Czech Republic, Germany, Japan, Malaysia, New Zealand, UK, USA
Intervention: hypothermia versus normothermia

Outcomes

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Mortality at end of follow‐up

2944
(32 studiesa)

⊕⊝⊝⊝
very lowb

Data not combined in meta‐analysis. Visual inspection of data showed variation in differences of effect not explained by subgroup analysis

Unfavourable outcome at end of follow‐up

2620
(27 studiesc)

⊕⊝⊝⊝
very lowd

Data not combined in meta‐analysis. Visual inspection of data showed variation in differences of effect not explained by subgroup analysis

Pneumonia

693
(14 studiese)

⊕⊕⊝⊝
lowf

Data not combined in meta‐analysis. Visual inspection of data showed variation in differences of effect

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

aWe identified 33 studies that reported data for mortality, with comparable data available for 32 studies
bFew studies had sufficiently described random sequence generation and concealment; downgraded one level for study limitations. Some inconsistencies between studies, not explained by per protocol subgroup analyses; downgraded one level for inconsistency. Some differences in study population between studies; Andrews 2015 included participants with less severe head injury, and with a longer delay in treatment; downgraded one level for indirectness.
cWe identified 29 studies that reported data for unfavourable outcome, with comparable data available for 26 studies.
dFew studies had sufficiently described random sequence generation and concealment; downgraded one level for study limitations. Some inconsistencies between studies not explained by per protocol subgroup analyses and we noted a moderate level of statistical heterogeneity; downgraded two levels for inconsistency. Some differences in study population between studies; Andrews 2015 included participants with less severe head injury, and with a longer delay in treatment; downgraded one level for indirectness.
eWe identified 14 studies that reported data for pneumonia, with comparable data available for 12 studies.
fSome inconsistencies between studies, not explained by per protocol subgroup analyses; downgraded one level for inconsistency. Some differences in study population between studies; Andrews 2015 included participants with less severe head injury, and with a longer delay in treatment; downgraded one level for indirectness.

Figuras y tablas -
Summary of findings for the main comparison. Hypothermia for traumatic brain injury
Comparison 1. Therapeutic cooling versus no cooling

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

32

Odds Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2 Unfavourable outcome Show forest plot

27

Odds Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3 Pneumonia Show forest plot

12

Odds Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Figuras y tablas -
Comparison 1. Therapeutic cooling versus no cooling
Comparison 2. Therapeutic cooling versus no cooling: by duration

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

32

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 24 hours

4

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 More than 24 hours

28

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Unfavourable outcome Show forest plot

26

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2.1 24 hours

3

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 More than 24 hours

23

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Pneumonia Show forest plot

12

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3.1 24 hours

2

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 More than 24 hours

10

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 2. Therapeutic cooling versus no cooling: by duration
Comparison 3. Therapeutic cooling versus no cooling: by length of follow‐up

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

32

Risk Ratio (IV, Fixed, 95% CI)

Totals not selected

1.1 One month

13

Risk Ratio (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 Three months

6

Risk Ratio (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 Six months

14

Risk Ratio (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.4 Twelve months or more

7

Risk Ratio (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Unfavourable outcome Show forest plot

26

Risk Ratio (IV, Fixed, 95% CI)

Totals not selected

2.1 Three months

9

Risk Ratio (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Six months

15

Risk Ratio (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.3 Twelve months

6

Risk Ratio (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 3. Therapeutic cooling versus no cooling: by length of follow‐up