Status:
RECRUITING
Improving Outcome in Subarachnoid Hemorrhage wIth Nadroparine
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Aneurysmal Subarachnoid Hemorrhage
Delayed Cerebral Ischemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage (aSAH) was long thought to be caused by subarachnoid blood-induced vasospasm. Experimental and clinical evidence suggest activa...
Detailed Description
One in every 20 strokes is caused by aneurysmal subarachnoid hemorrhage (aSAH). Mortality amounts to 32%-39%, and 50% of the survivors experience a permanent disability. Because half of the patients i...
Eligibility Criteria
Inclusion
- SAH confirmed by CT or lumbar puncture with the causative aneurysm confirmed by CT-A and/or digital subtraction angiography
- Coiling of the causative aneurysm within 72 hours of initial SAH
- Informed consent within 24 hours after coiling
Exclusion
- Stent-assisted coiling
- Use of anticoagulant medication post-coiling for other reasons
- Contra-indications for LMWH:
- Previous history of history of heparin-induced thrombocytopenia
- (Suspicion of) active arterial or venous bleeding
- Previous history of hemorrhagic diathesis due to coagulation disorders (with the ex-ception of disseminated intravascular coagulation)
- Severe hypertension: uncontrolled hypertension with a mean arterial pressure \>135mmHg
- Previous history of hypertensive or diabetic retinopathy
- Previous history of active infectious endocarditis
- Severe renal impairment (creatinine clearance \<30 mL / min)
- No proficiency of Dutch or English language
Key Trial Info
Start Date :
February 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04507178
Start Date
February 2 2022
End Date
April 1 2027
Last Update
January 29 2025
Active Locations (1)
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1
Amsterdam University Medical Centers
Amsterdam, Netherlands, 1087HV