Improving Outcome in Subarachnoid Hemorrhage wIth Nadroparine
Status:
Not yet recruiting
Trial end date:
2024-07-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)