Cerebral vasospasm (CV) is the most severe and dangerous complication in the early stages of hemorrhage, typically occurring within 3–14 days following the onset of bleeding. Although early treatment of aneurysms has become the primary means of preventing rebleeding, postoperative neurological complications are also common, including vasospasm, hydrocephalus, and rebleeding. ĭue to the complex pathophysiology of aSAH, it is often associated with ischemic and hemorrhagic complications. Approximately one third of patients require lifelong care, which greatly affects their quality of life and places a tremendous burden on society. Registered on March 30, 2023.Īneurysmal subarachnoid hemorrhage (aSAH) is a highly fatal disease with a high incidence rate, accounting for about 80% of cases of SAH, and 46% of aSAH survivors suffer from long-term cognitive impairment.
Trial registrationĬlinicalTrials ID: NCT05696639. This work will be published in peer-reviewed international medical journals and presented at medical conferences. This study protocol obtained ethical approval from the Ethics Committee of Baoan People’s Hospital, Shenzhen, Guangdong (approval number: BYL20220805).
The primary outcome was CV the second outcomes measures are occurrence of bleeding events, ischemic events, heparin-induced thrombocytopenia, deep vein thrombosis, cerebral venous circulation time, brain edema score, and hydrocephalus incidence. The study is an open-label, single-center, randomized controlled trial and aims to recruit 456 patients, with 228 patients in each group. Therefore, this study aims to compare the clinical outcomes associated with these two treatment approaches. Although most retrospective studies have confirmed the safety and effectiveness of unfractionated heparin (UFH) after aneurysm embolization therapy and its ability to reduce CV, there is still no randomized clinical trial comparing UFH and subcutaneous low-molecular-weight heparin (LMWH) injection in this population. Subcutaneous heparin injection is considered safe and effective, whereas continuous intravenous heparin infusion is still being debated due to the risk of bleeding. Heparin anticoagulation therapy is a widely used method to prevent cerebral vasospasm (CV) and venous thrombosis in patients with subarachnoid hemorrhage caused by ruptured cerebral aneurysms.
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