Platelet transfusion in brain haemorrhage

Platelet Transfusion in Cerebral Haemorrhage (PATCH)

Background

Stroke is a major cause of acquired disability in the Netherlands. After the care for children born with a handicap, the care for stroke patients consumes the largest portion of the total health care budget.

In recent years acute treatment in ischemic stroke improved significantly. Thrombolysis within 3 hours was shown to improve clinical outcome. However, for haemorrhagic stroke or intracerebral haemorrhage (ICH), which accounts for 15% of all stroke patients, no acute treatment option currently exists.
Haematoma volume is one of the most important outcome predictors in ICH. Because several studies have shown that haematoma volume increases during the first 6 hours after onset of ICH, reduction of this haematoma growth provides a promising target to improve outcome. Patients using platelet aggregation inhibitors (PAI) are especially at risk for haematoma growth and therefore platelet transfusion (PT) is an acute treatment option which should be investigated.



Objective

The objective of our study is to investigate whether platelet transfusion within 6 hours after onset of ICH can improve functional outcome by limiting haematoma growth in patients using PAI.



Study Design

Probe: Prospective, randomised, open treatment, blind end-point evaluation



Study Population

Patients with spontaneous ICH who were using PAI at least during the 7 days preceding haemorrhage.



Intervention

Patients are randomised to receive a single gift of platelets (5 or 10 donor units) within 6 hours after start of symptoms or standard care without platelet transfusion



Outcome

The primary endpoint is poor functional outcome as recorded on the modified Rankin Scale (mRS) at three months follow-up (mRS 4-6).

Secondary endpoints are complications of PT, haematoma enlargement on CT-scan, survival at three months, changes in outcome at three months (analysis of the mRS score as an ordinal scale ), poor outcome defined as mRS 3-6, disability assessed with the ALDS scale, cause of poor outcome, costs and predictive value of the CTA 'spot sign' and different laboratory measurements.



Sample Size

Poor outcome occurs in at least 70% of these patients. To detect a reduction of poor outcome from 70% to 50% with a two group Chi-square test with a 0.05 two-sided significance level and 80% power, 95 patients are needed in each group (190 patients in total).

Thirty centers are willing to participate in our study. If each center can randomize 3 to 4 patients each year, patient inclusion will be completed in 21 months. The last patient will then be assessed 2 years after the onset of the study.

Platelet transfusion limits haematoma growth and thus improves outcome in patients with intracerebral haemorrhage using anti-platelet therapy.

Primary outcome will be determined after 3 months.

- 95 patients receive platelet transfusion as soon as possible within 6 hours after onset

- 95 patients receive standard care



Platelet transfusion consists of a single gift of 5 or 10 donor units depending on type of anti-platelet medication (only patients using clopidogrel receive 10 units).