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. 2022 Nov 9;11(11):CD001245.
doi: 10.1002/14651858.CD001245.pub3.

Antifibrinolytic therapy for aneurysmal subarachnoid haemorrhage

Menno R Germans  1   2 , Wouter J Dronkers  3   4 , Merih I Baharoglu  4   5 , René Post  3   4 , Dagmar Verbaan  3   4 , Gabriel Je Rinkel  6 , Yvo Bwem Roos  4   5
Affiliations

Antifibrinolytic therapy for aneurysmal subarachnoid haemorrhage

Menno R Germans et al. Cochrane Database Syst Rev. .

Abstract

Background: Rebleeding is an important cause of death and disability in people with aneurysmal subarachnoid haemorrhage. Rebleeding is probably related to the dissolution of the blood clot at the site of the aneurysm rupture by natural fibrinolytic activity. This review is an update of previously published Cochrane Reviews.

Objectives: To assess the effects of antifibrinolytic treatment in people with aneurysmal subarachnoid haemorrhage.

Search methods: We searched the Cochrane Stroke Group Trials Register (May 2022), CENTRAL (in the Cochrane Library 2021, Issue 1), MEDLINE (December 2012 to May 2022), and Embase (December 2012 to May 2022). In an effort to identify further published, unpublished, and ongoing studies, we searched reference lists and trial registers, performed forward tracking of relevant references, and contacted drug companies (the latter in previous versions of this review).

Selection criteria: Randomised trials comparing oral or intravenous antifibrinolytic drugs (tranexamic acid, epsilon amino-caproic acid, or an equivalent) with control in people with subarachnoid haemorrhage of suspected or proven aneurysmal cause.

Data collection and analysis: Two review authors (MRG & WJD) independently selected trials for inclusion, and extracted the data for the current update. In total, three review authors (MIB & MRG in the previous update; MRG & WJD in the current update) assessed risk of bias. For the primary outcome, we dichotomised the outcome scales into good and poor outcome, with poor outcome defined as death, vegetative state, or (moderate) severe disability, assessed with either the Glasgow Outcome Scale or the Modified Rankin Scale. We assessed death from any cause, rates of rebleeding, delayed cerebral ischaemia, and hydrocephalus per treatment group. We expressed effects as risk ratios (RR) with 95% confidence intervals (CI). We used random-effects models for all analyses. We assessed the quality of the evidence with GRADE.

Main results: We included one new trial in this update, for a total of 11 included trials involving 2717 participants. The risk of bias was low in six studies. Five studies were open label, and we rated them at high risk of performance bias. We also rated one of these studies at high risk for attrition and reporting bias. Five trials reported on poor outcome (death, vegetative state, or (moderate) severe disability), with a pooled risk ratio (RR) of 1.03 (95% confidence interval (CI) 0.94 to 1.13; P = 0.53; 5 trials, 2359 participants; high-quality evidence), which showed no difference between groups. All trials reported on death from all causes, which showed no difference between groups, with a pooled RR of 1.02 (95% CI 0.90 to 1.16; P = 0.77; 11 trials, 2717 participants; high-quality evidence). In trials that combined short-term antifibrinolytic treatment (< 72 hours) with preventative measures for delayed cerebral ischaemia, the RR for poor outcome was 0.98 (95% CI 0.81 to 1.18; P = 0.83; 2 trials, 1318 participants; high-quality evidence). Antifibrinolytic treatment reduced the risk of rebleeding, reported at the end of follow-up (RR 0.65, 95% CI 0.47 to 0.91; P = 0.01; 11 trials, 2717 participants; absolute risk reduction 7%, 95% CI 3 to 12%; moderate-quality evidence), but there was heterogeneity (I² = 59%) between the trials. The pooled RR for delayed cerebral ischaemia was 1.27 (95% CI 1.00 to 1.62; P = 0.05; 7 trials, 2484 participants; moderate-quality evidence). However, this effect was less extreme after the implementation of ischaemia preventative measures and < 72 hours of treatment (RR 1.10, 95% CI 0.83 to 1.46; P = 0.49; 2 trials, 1318 participants; high-quality evidence). Antifibrinolytic treatment showed no effect on the reported rate of hydrocephalus (RR 1.09, 95% CI 0.99 to 1.20; P = 0.09; 6 trials, 1992 participants; high-quality evidence).

Authors' conclusions: The current evidence does not support the routine use of antifibrinolytic drugs in the treatment of people with aneurysmal subarachnoid haemorrhage. More specifically, early administration with concomitant treatment strategies to prevent delayed cerebral ischaemia does not improve clinical outcome. There is sufficient evidence from multiple randomised controlled trials to incorporate this conclusion in treatment guidelines.

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Conflict of interest statement

Menno Germans: co‐investigator in Post 2021 Wouter Dronkers: none known Merih Baharoglu: none known René Post: investigator in Post 2021 Dagmar Verbaan: principal investigator in Post 2021 Gabriel Rinkel: co‐investigator in Roos 2000a Yvo Roos: principal investigator in Roos 2000a None of the review authors have any financial or other commercial conflict of interest to disclose.

Figures

1
1
PRISMA overview of updated search (December 2012 to May 2022)
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
3
3
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
4
4
Funnel plot of included trials assessing case fatality
5
5
Funnel plot of included trials assessing rebleeding
1.1
1.1. Analysis
Comparison 1: Antifibrinolytic treatment versus control treatment with or without placebo, Outcome 1: Poor outcome (death, vegetative, or (moderate) severe disability) at end of follow‐up: open versus blind studies
1.2
1.2. Analysis
Comparison 1: Antifibrinolytic treatment versus control treatment with or without placebo, Outcome 2: Poor outcome (death, vegetative, or (moderate) severe disability) at end of follow‐up: trials with and without ischaemia prevention, according to treatment duration
1.3
1.3. Analysis
Comparison 1: Antifibrinolytic treatment versus control treatment with or without placebo, Outcome 3: Death from all causes at end of follow‐up: open versus blind studies
1.4
1.4. Analysis
Comparison 1: Antifibrinolytic treatment versus control treatment with or without placebo, Outcome 4: Death from all causes at end of follow‐up: trials with and without ischaemia prevention, according to treatment duration
1.5
1.5. Analysis
Comparison 1: Antifibrinolytic treatment versus control treatment with or without placebo, Outcome 5: Rebleeding reported at end of follow‐up: open versus blind studies
1.6
1.6. Analysis
Comparison 1: Antifibrinolytic treatment versus control treatment with or without placebo, Outcome 6: Confirmed rebleeding at end of follow‐up (sensitivity analysis): open versus blind studies
1.7
1.7. Analysis
Comparison 1: Antifibrinolytic treatment versus control treatment with or without placebo, Outcome 7: Rebleeding reported at end of follow‐up: trials with and without ischaemia prevention, according to treatment duration
1.8
1.8. Analysis
Comparison 1: Antifibrinolytic treatment versus control treatment with or without placebo, Outcome 8: Delayed cerebral ischaemia reported at end of follow‐up: open versus blind studies
1.9
1.9. Analysis
Comparison 1: Antifibrinolytic treatment versus control treatment with or without placebo, Outcome 9: Confirmed cerebral ischaemia at end of follow‐up (sensitivity analysis): open versus blind studies
1.10
1.10. Analysis
Comparison 1: Antifibrinolytic treatment versus control treatment with or without placebo, Outcome 10: Delayed cerebral ischaemia reported at end of follow‐up: trials with and without ischaemia prevention, according to treatment duration
1.11
1.11. Analysis
Comparison 1: Antifibrinolytic treatment versus control treatment with or without placebo, Outcome 11: Hydrocephalus reported at end of follow‐up: open versus blind studies
1.12
1.12. Analysis
Comparison 1: Antifibrinolytic treatment versus control treatment with or without placebo, Outcome 12: Confirmed hydrocephalus at end of follow‐up (sensitivity analysis): open versus blind studies
1.13
1.13. Analysis
Comparison 1: Antifibrinolytic treatment versus control treatment with or without placebo, Outcome 13: Hydrocephalus reported at end of follow‐up: trials with and without ischaemia prevention, according to treatment duration
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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References to other published versions of this review

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