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Risk of bias summary of the included studies
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Figure 1

Risk of bias summary of the included studies

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Trial flow diagram
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Figure 2

Trial flow diagram

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Comparison 1 Antifibrinolytic therapy versus placebo in hemophilia, Outcome 1 Number of people with postoperative bleedings.
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Analysis 1.1

Comparison 1 Antifibrinolytic therapy versus placebo in hemophilia, Outcome 1 Number of people with postoperative bleedings.

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Comparison 1 Antifibrinolytic therapy versus placebo in hemophilia, Outcome 2 Number of side effects requiring withdrawal.
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Analysis 1.2

Comparison 1 Antifibrinolytic therapy versus placebo in hemophilia, Outcome 2 Number of side effects requiring withdrawal.

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Summary of findings for the main comparison. Summary of findings table

Antifibrinolytic therapy compared with placebo or usual care for preventing oral bleeding in patients with haemophilia or Von Willebrand disease undergoing oral or dental procedures

Patient or population: people with haemophilia or Von Willebrand disease

Settings: hospitals, hemophilia centres

Intervention: tranexamic acid (TXA) or epsilon aminocaproic acid (EACA)

Comparison: placebo or no intervention or usual care with or without placebo

Outcomes

Anticipated absolute effects*

Relative effect
(95% CI)

№ of participants
(studies)

Number needed to treat (NNT)

Quality of the evidence
(GRADE)

Comments

Risk with placebo or usual care

Risk with antifibrinolytic therapy

Postoperative bleedings requiring intervention

Study population

Risk difference:

57
(36 to 76)

59
(2 RCTs)

1.8

⊕⊕⊕⊝
MODERATE 1 2 3

67 per 100

(20 events)

10 per 100

(3 events)

Side effects or other adverse events

Study population

Risk difference:

3.4
(‐32 to 38)

59
(2 RCTs)

0.3

⊕⊕⊝⊝
LOW 2 3

0 events

1 event

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; RR: risk ratio; OR: odds ratio;

GRADE Working Group grades of evidence
High quality: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: we are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 The magnitude of effect was considered large in this study, therefore the quality of evidence was rated up one level.

2 Small sample sizes and lack of studies

3 Heterogeneity between the included trials regarding the proportion of severe people with haemophilia included, the concomitant standard therapy and fibrinolytic agent treatment regimens used

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Summary of findings for the main comparison. Summary of findings table
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Table 1. Results of the included studies: primary outcomes

Antifibrinolytic therapy compared with placebo or usual care for preventing oral bleeding in people with haemophilia or Von Willebrand disease undergoing oral or dental procedures

Patient or population: people with haemophilia or Von Willebrand disease

Settings: hospitals, hemophilia centres

Intervention: tranexamic acid (TXA) or epsilon aminocaproic acid (EACA)

Comparison: placebo or no intervention or usual care with or without placebo

Primary outcomes

1. Postoperative bleedings requiring intervention

2. Side effects or other adverse events

Absolute risks % (n/ntotal)

Risk difference (RD)
% (95% CI)

Number needed to treat (NNT)

Absolute risks % (n/ntotal)

Risk difference (RD)

(% (95% CI)

Control

Intervention

Control

Intervention

A.Forbes 1972

79% (11/14)

14% (2/14)

65% (37 ‐ 93)

1.5

0% (0/14)

0% (0/14)

0%

B.Walsh 1971

56% (9/16)

7% (1/15)

49% (21 ‐ 77)

2.0

0% (0/16)

7% (1/15)

7% (‐0.06 ‐ 20)

n: number; CI: confidence interval

Figuras y tablas -
Table 1. Results of the included studies: primary outcomes
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Table 2. Results of the included studies: combination of results in absolute numbers

Antifibrinolytic therapy compared with placebo or usual care for preventing oral bleeding in people with haemophilia or Von Willebrand disease undergoing oral or dental procedures

Patient or population: people with haemophilia or Von Willebrand disease

Settings: hospitals, hemophilia centres

Intervention: tranexamic acid (TXA) or epsilon aminocaproic acid (EACA)

Comparison: placebo or no intervention or usual care with or without placebo

1. Number of people with postoperative bleeding

2. Side effects or other adverse events

Combined absolute risks % (n/ntotal)

Risk difference (RD) (% (95% CI)

Number needed to treat (NNT)

Combined absolute risks % (n/ntotal)

Risk difference (RD)(% (95% CI)

Number needed to treat (NNT)

Control

Intervention

Control

Intervention

Forbes 1972; Walsh 1971

67% (20/30)

10% (3/29)

56% (36% ‐ 76%)

1.8

0% (0/30)

3.4 (1/29)

3.4 (‐32 ‐ 38)

0.3
Figuras y tablas -
Table 2. Results of the included studies: combination of results in absolute numbers
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Table 3. Results of the included studies: secondary outcomes

Antifibrinolytic therapy compared with placebo or usual care for preventing oral bleeding in patients with haemophilia or Von Willebrand disease undergoing oral or dental procedures

Patient or population: Patients with haemophilia or Von Willebrand disease

Settings: Hospitals, Hemophilia centres

Intervention: Tranexamic acid (TXA) or epsilon aminocaproic acid (EACA)

Comparison: Placebo or no intervention or usual care with or without placebo

Secondary outcomes

1. (Mean) fall in haemoglobin level from baseline

2. Amount of postoperative blood loss: mean per patient mL (range)

3. Need for and dose of clotting factor concentrates:

Mean number of units IU (range) of replacement therapy per root extracted (A) / per patient (B)

Control

Intervention

Control

Intervention

Control

Intervention

A.Forbes 1972

1.4 g/100mL

0.3 g/100mL

84.1 mL (4‐323)

61.2 mL (1‐749)

617 IU (0‐15800) in eleven participants

30 IU and 65 IU in two participants

B.Walsh 1971

Trial centre 1: 6.3%

Trial centre 2: 6.3%

Trial centre 1: 3.9%

Trial centre 2: 3.7%

NR

NR

Trial centre 1: 2331 IU

Trial centre 2: 1881 IU

Trial centre 1: 145 IU

Trial centre 2: 0 IU

Abbreviations:NR: not reported

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Table 3. Results of the included studies: secondary outcomes
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Comparison 1. Antifibrinolytic therapy versus placebo in hemophilia

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of people with postoperative bleedings Show forest plot

2

59

Risk Difference (M‐H, Random, 95% CI)

‐0.57 [‐0.76, ‐0.37]

2 Number of side effects requiring withdrawal Show forest plot

2

59

Risk Difference (M‐H, Random, 95% CI)

0.03 [‐0.08, 0.13]
Figuras y tablas -
Comparison 1. Antifibrinolytic therapy versus placebo in hemophilia
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