Using Nadroparin to Improve Outcomes in Patients with Aneurysmal Subarachnoid Hemorrhage
Improving Outcome in Subarachnoid Hemorrhage wIth Nadroparine
PHASE2 · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT04507178
This study is testing if giving higher doses of Nadroparin can help patients who have had an aneurysmal subarachnoid hemorrhage live longer and have better recovery outcomes compared to standard doses.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other) |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT04507178 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of therapeutic low-molecular weight heparin (Nadroparin) on patients who have experienced an aneurysmal subarachnoid hemorrhage (aSAH). The study aims to determine if higher doses of Nadroparin can reduce the 30-day mortality rate compared to standard prophylactic doses. It also seeks to explore differences in clinical outcomes related to delayed cerebral ischemia (DCI) in these patients. Participants will be monitored for their response to treatment following the coiling of the causative aneurysm.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with aSAH who have undergone coiling of the aneurysm within 72 hours of the initial hemorrhage.
Not a fit: Patients with contraindications for low-molecular weight heparin or those who have undergone stent-assisted coiling may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly lower mortality rates and improve recovery outcomes for patients with aSAH.
How similar studies have performed: Previous studies have indicated potential benefits of therapeutic LMWH in similar patient populations, suggesting this approach may be promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: 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
Where this trial is running
Amsterdam
- Amsterdam University Medical Centers — Amsterdam, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Dagmar Verbaan, PhD
- Email: d.verbaan@amsterdamumc.nl
- Phone: +31205663316
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aneurysmal Subarachnoid Hemorrhage, Delayed Cerebral Ischemia, nadroparin, subarachnoid hemorrhage, brain ischemia, delayed cerebral ischemia