Platelet Transfusion in Cerebral Haemorrhage

Phase 3

• Conditions: brain haemorrhage; intracerebral haemorrhage (ICH); 10007963; 10047075

• Registration Number: NL-OMON31663
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 190

Inclusion Criteria

- Age 18-75 years
- Patients with non-traumatic, supratentorial ICH confirmed by CT
- Haematoma volume < 150 cc
- Glagow Coma Scale score 8-15
- Platelet aggregation inhibitors used at least seven days preceding haemorrhage
- Treatment can be initiated within 6 hours after onset of first signs and within 1* hours of the CT scan
- Pre-stroke Rankin scale score 0 or 1 (No symptoms, No significant disability despite
symptoms; able to carry out all usual duties and activities)

Exclusion Criteria

- Haematoma on CT compatible with epidural, subdural, aneurysmal or arterio-venous malformation (AVM) haematoma
- Planned surgical evacuation of haematoma within 24 hours after admission
- Presence of intraventricular blood if more than sedimentation in the posterior horns of the lateral ventricles
- Previous adverse reaction after platelet transfusion
- Previously legally incompetent adults
- Death appears imminent
- Known use of vitamin K antagonists (unless INR < 1.3)
- Known thrombocytopenia < 100 x 10E9/l
- History of coagulopathy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Three months after randomisation patients functional health outcome is scored<br /><br>on the modified Rankin Scale (mRS), poor outcome is defined as a score of 3-6. </p><br>