Safety and Efficacy of Low-dose Heparin During Intracranial Angioplasty and Stent Placement "SELHIAS "

Completed

Phase N/A Results

Trial Description

To compare intra-operative two doses of heparin regimen (low dose verses high dose), and to evaluate safety and efficacy of low-dose heparin in patients undergoing intracranial angioplasty and stent placement.

Interventions

Trial Design

Randomized, double-blind, controlled, single-center trial.

Patient Involvement

Patients are being randomly assigned to two groups, low-dose group who receive 2000 IU heparin intravenous bolus plus 500 IU/hr and high-dose group who receive 3000 IU heparin intravenous bolus plus 800 IU/hr after placement of an arterial sheath during intracranial angioplasty and stenting procedure.

Outcomes

Type Measure Time Frame Safety Issue
Primary Efficacy end point will be the thrombo-embolic complications within 24 hour and safety end point will be intracranial bleeding complications within 24 hour of intracranial angioplasty and stenting procedure.
Secondary Intra-operative activated clotting time (ACT) and bleeding complications at puncture site.

Sponsors

The Ministry of Health of the People's Republic of China