Safety and Efficacy of Low-dose hEparinization in Cerebral Angiography sTudy (NCT06365398) | Clinical Trial Compass
CompletedPhase 4
Safety and Efficacy of Low-dose hEparinization in Cerebral Angiography sTudy
China180 participantsStarted 2018-01-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. aged 18-65 years;
✓. suspected cerebrovascular disease, including vascular lesions of the carotid, middle cerebral, anterior cerebral, vertebral, basilar, and posterior cerebral arteries;
✓. Activity of daily living (ADL) score between 85\~100;
✓. normal coagulation function and no prior anticoagulant therapy before DSA;
✓. fully informed consent to participate in the study.
Exclusion criteria
✕. iodine allergy;
✕. hepatic and/or renal insufficiency;
✕. severe hypertension with poor blood pressure control;