Efficacy and Safety of Bivalirudin Versus Heparin During Coil Embolization in Patients With Ruptured Intracranial Aneurysms

• Status: Not yet recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, open label, multi-center, positive-controlled study, in which a total of 236 patients will be enrolled and randomly assigned to receive bivalirudin or heparin in a 1:1 ratio during coil embolization in patients with ruptured intracranial aneurysms.

Procedure-related complication, mRS, Activated Clotting Time, ischemic and hemorrhagic complications, symptomatic and asymptomatic intracranial hemorrhage, death, Heparin Induced Thrombocytopenia will be evaluated during procedure, at 24hs, 7days and 30 days after.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Changhai Hospital
• Collaborators: Qilu Hospital of Shandong University; The First Affiliated Hospital of Zhengzhou University; The First People's Hospital of Changzhou; Wuhan University; Zhejiang University
• Treatments: Bivalirudin; Heparin

Criteria

Inclusion Criteria:

• Aged 18 to 80 years, any gender

• intracranial aneurysms ruptured in 14 days

• Diagnosed as subarachnoid hemorrhage (SAH) by CT, confirmed aneurysmal SAH by DSA

• Hunt-Hess I-III

• Patient is suitable for coil embolization

• Informed consent and availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements

Exclusion Criteria:

• Nonsaccular Aneurysms (include infective, fusiform, dissecting aneurysms)

• Prior intracranial aneurysms

• Poor baseline of mRS 4-5

• Aneurysms that cannot be successfully treated by interventional treatment judged by clinician.

• Patients cannot receive antiplatelet aggregation or anticoagulant therapy

• Patients with indications for emergency craniotomy: intracranial hematoma, high intracranial pressure or hydrocephalus etc..

• Patients with AVM, intracranial artery stenosis or moyamoya disease

• Pregnancy or lactation

• Patients with severe abnormal function of main organs, liver or kidney

• Other serious diseases not suitable for this study

• Patients are currently participating in another drug-related clinical study

• Patients are allergic to heparin or bivalirudin and its excipients or hirudin

• Patients with a clear history of allergy to coil embolic material

• Patients had or may have had severe reactions to contrast media that could not complete the preoperative medication

• Patients are not suitable to participate in this clinical study judged by clinician