Efficacy and Safety of Bivalirudin Versus Heparin During Coil Embolization in Patients With Ruptured Intracranial Aneurysms
NCT ID: NCT04532333
Last Updated: 2020-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
236 participants
INTERVENTIONAL
2020-08-31
2021-06-30
Brief Summary
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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.
Detailed Description
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The administration of anticoagulant may reduce thromboembolic events during the endovascular embolization, meanwhile, involves the risk of bleeding. Although heparin is commonly used during the procedure, the safety in patients with ruptured intracranial aneurysms has not been established. In contrast to heparin, bivalirudin is a short-lived direct thrombin inhibitor with an intrinsic antiplatelet activity and more stable pharmacokinetic and pharmacodynamic properties which has been associated with reduced bleeding and an overall favorable profile. Bivalirudin administration in patients with high bleeding risk during coronary intervention is recommended by current guidelines.
This is an open label, multicenter, randomized pilot study, which is aimed to investigate the safety and efficacy of bivalirudin coil embolization in patients with ruptured intracranial aneurysms.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Bivalirudin
Bivalirudin at full dose Bivalirudin 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until end of the procedure
Bivalirudin 250 MG Injection
Bivalirudin 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until end of the procedure
Heparin
Heparin first dose at 0.6mg/kg(75U/kg) Heparin should be administered each hour, 0.6mg/kg(75U/kg) as bolus dose, 0.3mg/kg 1h later, 10mg(1250U) every hour after.
Heparin
Heparin should be administered each hour, 0.6mg/kg(75U/kg) as bolus dose, 0.3mg/kg 1h later, 10mg(1250U) every hour after.
Interventions
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Bivalirudin 250 MG Injection
Bivalirudin 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until end of the procedure
Heparin
Heparin should be administered each hour, 0.6mg/kg(75U/kg) as bolus dose, 0.3mg/kg 1h later, 10mg(1250U) every hour after.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Zhengzhou University
OTHER
Zhejiang University
OTHER
Wuhan University
OTHER
Qilu Hospital of Shandong University
OTHER
The First People's Hospital of Changzhou
OTHER
Changhai Hospital
OTHER
Responsible Party
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Jian-min Liu
Dean of Neurosurgical Department,Changhai Hospital,Shanghai,China
Principal Investigators
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Jianmin Liu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Neurosurgical Department of Changhai Hospital
Sheng Guan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Neurointerventional Department, The First Affiliated Hospital of Zhengzhou University
Central Contacts
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Other Identifiers
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CHEC2020-042
Identifier Type: -
Identifier Source: org_study_id