Evaluating Higher Dose Nadroparin to Improve Survival and Outcomes
in Adults With Aneurysmal Subarachnoid Hemorrhage Treated by Endovascular Coiling
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-01-29
100
Participants Needed
1
Research Sites
34 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether using a higher dose of low-molecular weight heparin LMWH called nadroparin can reduce the 30-day mortality rate in patients who have suffered an aneurysmal subarachnoid hemorrhage aSAH and were treated with endovascular coiling. This condition, a type of stroke caused by bleeding around the brain, has a high risk of delayed cerebral ischemia DCI, which contributes significantly to death and disability. The study is a phase II randomized clinical trial aiming to improve outcomes by comparing therapeutic versus prophylactic doses of LMWH in adults aged 18 and older.
Participants are randomly assigned to one of two groups one group receives a higher therapeutic dose of nadroparin twice daily starting within 24 hours after coiling and continuing for 21 days post-hemorrhage, followed by the standard prophylactic dose until discharge or sufficient mobilization. The other group receives the standard prophylactic dose once daily until discharge or mobilization. The trial also monitors various secondary outcomes, including development of DCI, bleeding complications, hydrocephalus, discharge location, quality of life, cognitive function, and healthcare costs.
During the study, participants undergo assessments for mortality at 30 days, as well as evaluations of neurological complications and recovery over six months. Researchers track bleeding events, cognitive function, and overall clinical status using clinical exams and patient-reported outcomes. Safety is monitored closely due to potential bleeding risks. The total participation includes the initial treatment period and follow-up visits to assess longer-term health and functional outcomes after the hemorrhage.
CONDITIONS
Brief Title
Improving Outcome in Subarachnoid Hemorrhage wIth Nadroparine
Research Team
D
Dagmar Verbaan, PhD
W
William P Vandertop, MD PhD
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Aneurysmal subarachnoid hemorrhage confirmed by CT or lumbar puncture with the causative aneurysm confirmed by CT-angiography or digital subtraction angiography
Treatment of the causative aneurysm by endovascular coiling within 72 hours of initial hemorrhage
Informed consent obtained within 24 hours after coiling
Age 18 years or older
You will not qualify if you...
Stent-assisted coiling
Use of anticoagulant medication after coiling for reasons other than the study
History of heparin-induced thrombocytopenia
Suspected or active arterial or venous bleeding
History of hemorrhagic diathesis due to coagulation disorders (except disseminated intravascular coagulation)
Severe uncontrolled hypertension with mean arterial pressure above 135 mmHg
History of hypertensive or diabetic retinopathy
History of active infectious endocarditis
Severe renal impairment with creatinine clearance less than 30 mL/min
Inability to speak Dutch or English
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 21 days
Participants receive either a higher dose or a prophylactic dose of LMWH starting within 24 hours after coiling and continuing for 21 days to investigate effects on delayed cerebral ischemia and other complications.
Daily subcutaneous injections for 21 days
Follow-up
Duration - Up to 6 months
Participants are monitored for longer-term outcomes including mortality, neurological impairment, cognitive functioning, and discharge destination up to 6 months after treatment.
Assessments at 30 days and 6 months post-treatment
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Evaluating Higher Dose Nadroparin to Improve Survival and Outcomes
in Adults With Aneurysmal Subarachnoid Hemorrhage Treated by Endovascular Coiling
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Published Research Related To This Trial
The durability of endovascular coiling versus neurosurgical clipping of ruptured cerebral aneurysms: 18 year follow-up of the UK cohort of the International Subarachnoid Aneurysm Trial (ISAT).
Andrew J Molyneux, Jacqueline Birks, Alison Clarke...
Low-molecular weight and unfractionated heparins induce a downregulation of inflammation: decreased levels of proinflammatory cytokines and nuclear factor-kappaB in LPS-stimulated human monocytes.
Hélène Hochart, P Vincent Jenkins, Owen P Smith...