Improving Outcome in Subarachnoid Hemorrhage wIth Nadroparine

Who is this study for? Patients with subarachnoid hemorrhage
What treatments are being studied? Nadroparin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 activation of several pathophysiological pathways, affecting the cerebral microcirculation. Recently, lower in-hospital mortality and less non-home discharge was reported in patients treated with therapeutic low-molecular weight heparin (LMWH), compared to patients with standard, prophylactic LMWH, pointing towards a potential benefit of higher doses of LMWH in the acute course after aSAH. Treatment with therapeutic LMWH might improve clinical outcome in endovascularly treated aSAH patients. The primary objective is to evaluate whether aSAH patients treated with therapeutic LMWH have a lower 30-day mortality rate compared to patients treated with prophylactic LMWH. Secondary objectives are to evaluate whether there are significant differences between patients treated with therapeutic and prophylactic LMWH in development of DCI, (hemorrhagic) complications during admission, hydrocephalus, non-home discharge location, quality of life, clinical outcome and cognitive functioning at three and six months, total health care costs. A single center, prospective, phase II randomized clinical trial in aneurysmal SAH patients ≥18 years old, in whom the causative aneurysm is treated with endovascular coiling less than 72 hours after initial SAH. Patients are randomized into 2 groups: (1) Therapeutic dose LMWH group: the standard prophylactic dose, administered upon hospital admission, will be replaced by nadroparin s.c. twice daily 5700 IE anti-Xa, starting within 24 hours after coiling and continued until 21 days after ictus of initial SAH. After 21 days, patients will continue with standard care prophylactic dose until discharge or when mobilized for more than 6 hours per day; (2) Control group: standard of care treatment with prophylactic dose of LMWH; nadroparin, s.c. once daily 2850 AxaIU until discharge or when mobilized for at least 6 hours a day. Primary outcome: 30-days' mortality. Secondary outcome: DCI, venous thrombo-embolic complications, occurrence of major and non-major bleeding, hemorrhagic complications after external ventricular/lumbar drain (EVD/ELD) placement and lumbar puncture (LP), other SAH-related complications, shunt-dependent hydrocephalus, discharge location, quality of life, total health care costs, cognitive functioning, clinical outcome.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Amsterdam University Medical Centers
RECRUITING
Amsterdam
Contact Information
Primary
Dagmar Verbaan, PhD
d.verbaan@amsterdamumc.nl
+31205663316
Backup
William P Vandertop, MD PhD
wp.vandertop@amsterdamumc.nl
+31205669111
Time Frame
Start Date: 2022-02-02
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 100
Treatments
No_intervention: prophylactic dose LMWH
Patients assigned to the control group will receive standard care according to current protocol with a prophylactic dose of LMWH (nadroparin once daily 2850 AxaIE subcutaneously) starting within 24 hours after coiling, continued until discharge or when mobilized for at least six hours a day.
Active_comparator: therapeutic dose LMWH
In the intervention group, the standard prophylactic dose will be replaced by a higher dose of LMWH (nadroparin; twice daily 5700 IE) starting within 24 hours after coiling and continued for 21 days after initial SAH. After this, patients will continue with standard care (prophylactic dose until discharge or when mobilized for more than six hours per day).
Related Therapeutic Areas
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov

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