NL-OMON31663
Not yet recruiting
Phase 3
Platelet Transfusion in Cerebral Haemorrhage - PATCH
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 190
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
Investigators
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