drugset / Trial / NCT06365398

Safety and Efficacy of Low-dose hEparinization in Cerebral Angiography sTudy

NCT06365398

Phase 4 Completed 180 enrolled Xuanwu Hospital, Beijing
RandomizedParallel-groupTriple-blindTreatment

Summary

Purpose: Systemic heparinization is a widely used technique on digital subtraction angiography (DSA). Heparin, however, is associated with a variety of complications, including hemorrhage, thrombocytopenia, and hematomas. This study aimed to investigate the safety and efficacy of micro-dose systemic heparinization or no heparinization on cerebral angiography for cerebrovascular diseases. Methods: A prospective, single-blind, randomized controlled study on patients who experienced transient ischemic attacks (TIAs) or acute ischemic strokes and underwent DSA is performed. Participants are randomized into three groups: regular-dose systemic heparinization, micro-dose systemic heparinization, and no heparinization. Information on patient demographics, laboratory tests, perioperative complications, and back pain scores is collected. Safety endpoints are defined as cerebral ischemic events and local complications of puncture site. Efficacy endpoints were defined as the recovery of the patients.

Timeline

Start
2018-01-01
Primary completion
2021-06-01
Completion
2022-01-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Heparin Other / unclassified 42 iu/kg Intravenous
Comparator Heparin Other / unclassified 83 iu/kg Intravenous

Indications

No indication recorded.