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

NCT04532333 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2020-08-31

No results posted yet for this study

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.

Conditions

  • Subarachnoid Hemorrhage, Aneurysmal

Interventions

DRUG

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

DRUG

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • Zhejiang University

    collaborator OTHER

  • Wuhan University

    collaborator OTHER

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • The First People's Hospital of Changzhou

    collaborator OTHER

  • Changhai Hospital

    lead OTHER

Principal Investigators

  • Jianmin Liu, M.D. · Neurosurgical Department of Changhai Hospital

  • Sheng Guan, M.D. · Neurointerventional Department, The First Affiliated Hospital of Zhengzhou University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-31
Primary Completion
2021-05-31
Completion
2021-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04532333 on ClinicalTrials.gov