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Intervention Review

Haemostatic drug therapies for acute primary intracerebral haemorrhage

  1. Hong You1,*,
  2. Rustam Al-Shahi Salman2

Editorial Group: Cochrane Stroke Group

Published Online: 19 JUL 2006

Assessed as up-to-date: 13 MAY 2006

DOI: 10.1002/14651858.CD005951.pub2

How to Cite

You H, Al-Shahi Salman R. Haemostatic drug therapies for acute primary intracerebral haemorrhage. Cochrane Database of Systematic Reviews 2006, Issue 3. Art. No.: CD005951. DOI: 10.1002/14651858.CD005951.pub2.

Author Information

  1. 1

    GanSu Province Peoples' Hospital, Department of Neurology and Neurosurgery, LanZhou, GanSu Province, China

  2. 2

    University of Edinburgh, Department of Clinical Neurosciences, Edinburgh, UK

*Hong You, Department of Neurology and Neurosurgery, GanSu Province Peoples' Hospital, DongGang Western Road No 96, LanZhou, GanSu Province, 730000, China.

Publication History

  1. Publication Status: Unchanged
  2. Published Online: 19 JUL 2006


This is not the most recent version of the article. View current version (07 OCT 2009)



  1. Top of page
  2. Abstract
  3. Plain language summary


Because primary intracerebral haemorrhage (PICH) volume influences its outcome and a third of PICHs enlarge by a third within 24 hours of onset, early haemostatic drug therapy might improve outcome.


To examine the clinical effectiveness and safety of haemostatic drug therapies for acute PICH in a randomised controlled trial (RCT) design.

Search strategy

We searched the Cochrane Stroke Group Trials Register (last searched May 2006), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2006), MEDLINE (1966 to August 2005) and EMBASE (1980 to August 2005). In an effort to identify further published, ongoing and unpublished studies we scanned bibliographies of relevant articles, searched international registers of clinical trials and research, and contacted authors and pharmaceutical companies.

Selection criteria

We sought RCTs of any haemostatic drug therapy for acute PICH, compared against placebo or open control, with relevant clinical outcome measures.

Data collection and analysis

Two review authors independently applied the inclusion criteria, reviewed the relevant studies, and extracted data from them.

Main results

We found four phase II RCTs, involving adults aged 18 years or over, within four hours of PICH: 116 received placebo and 373 participants received haemostatic drugs (two received epsilon-aminocaproic acid (EACA) and 371 received recombinant activated factor VII (rFVIIa)). Haemostatic drugs appeared to reduce the risk of death or dependence on the modified Rankin Scale (grades 4 to 6) within 90 days of PICH (risk reduction 0.79 (95% confidence intervals (CI) 0.67 to 0.93)), but not when assessed by the extended Glasgow Outcome Scale (risk reduction 0.90 (95%CI 0.81 to 1.01)). There was a statistically significant excess of arterial thromboembolism at 160 mcg/kg rFVIIa.

Authors' conclusions

Current evidence for the use of haemostatic drugs in the treatment of acute PICH cannot provide clear guidelines for clinical practice. Adults with acute PICH may benefit from haemostatic therapy with rFVIIa, but the evidence on major clinical outcomes is neither robust nor precise. Large phase III RCTs of rFVIIa - and other less costly drugs - are necessary.


Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary

Haemostatic drug therapies for acute primary intracerebral haemorrhage

Up to one fifth of all strokes are caused by intracerebral haemorrhage. Most are due to primary intracerebral haemorrhage (PICH) in which there is no identifiable cause. Some PICH enlarge within the first 24 hours and the bigger the PICH the more likely it is to be fatal. Therefore, drugs that promote clotting - known as haemostatic drugs - might reduce the risk of death or being disabled after PICH by limiting its growth. But haemostatic drugs can cause unwanted clotting (such as heart attacks and clots in leg veins). We reviewed the evidence from four phase II randomised controlled trials involving adults. Recombinant activated factor VII (rFVIIa) was the most widely tested drug. Although rFVIIa reduced the risk of a bad outcome (death or dependence) within 90 days of PICH, the highest dose of rFVIIa caused an excess of unwanted clots in arteries. Put together, the trial results were imprecise, and the apparent benefit needs to be confirmed by much larger trials. At the moment, only one person in every eight with PICH would be eligible for rFVIIa treatment, so the use of these drugs later than four hours after PICH merits study, as does their use in people with a past history of a blood clot. Furthermore, other drugs are cheaper than rFVIIa, and perhaps equally effective, so they too may be worth testing in further large scale trials.