Improving Outcome in Subarachnoid Hemorrhage with Nadroparin: A Phase II Randomized Trial Comparing Therapeutic and Prophylactic Doses of LMWH

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.

Improving Outcome in Subarachnoid Hemorrhage wIth Nadroparine