Improving Outcome in Subarachnoid Hemorrhage wIth Nadroparine

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Aug 7, 2020

Keywords

ClinConnect Summary

This clinical trial is studying whether a higher dose of a blood thinner called nadroparin can help patients who have experienced a type of bleeding in the brain known as aneurysmal subarachnoid hemorrhage (aSAH). The main goal is to see if patients receiving this higher dose have a lower risk of dying within 30 days compared to those receiving a standard, lower dose. Researchers are also looking at other important outcomes, such as whether patients develop complications, their quality of life after treatment, and any additional healthcare costs.

To participate in the trial, patients must be at least 18 years old, have confirmed bleeding in the brain due to an aneurysm, and be treated with a specific procedure called coiling within 72 hours of the bleeding event. Participants will be randomly assigned to receive either the higher or standard dose of the blood thinner for 21 days. Throughout the study, patients will be monitored for various health outcomes. This trial is currently recruiting participants, and it's important to remember that those interested should be able to understand Dutch or English to provide informed consent.

Gender

ALL

Eligibility 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