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

Capital Medical University

Status and phase: Completed; Phase 4

Conditions: Cerebral Angiography; Heparinization

Treatments: Drug: Heparin; Other: No heparinization; Drug: Heparin Sodium Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06365398

XWHL-2018010 (Other Grant/Funding Number)

SELECT

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. aged 18-65 years;
2. suspected cerebrovascular disease, including vascular lesions of the carotid, middle cerebral, anterior cerebral, vertebral, basilar, and posterior cerebral arteries;
3. Activity of daily living (ADL) score between 85~100;
4. normal coagulation function and no prior anticoagulant therapy before DSA;
5. fully informed consent to participate in the study.

Exclusion criteria

1. iodine allergy;
2. hepatic and/or renal insufficiency;
3. severe hypertension with poor blood pressure control;
4. hemorrhagic diseases;
5. hyperlipidemia;
6. poor glycemic control in diabetes;
7. pregnancy;
8. atrial fibrillation;
9. undergoing interventional treatment simultaneously.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 3 patient groups

Regular-dose group

Active Comparator group

Description:

3000\~5000 Units of normal heparin was injected via the sheath tube in the systemic heparinization (Regular-dose) group. Half a dose of normal heparin is added after the imaging session has lasted more than half an hour.

Treatment:

Drug: Heparin

Micro-dose group

Experimental group

Description:

Micro-dose group is performed with two bags of 500 milliliter(ml) saline with 2500 Units of heparin were used to make a 5000 Units per liter heparin saline, which was used to infuse anticoagulation.

Treatment:

Drug: Heparin Sodium Injection

heparinization group

Experimental group

Description:

No heparinization is performed with no additional heparin is administered by a sheath or arterial route in the third group.

Treatment:

Other: No heparinization