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

Phase 4

Completed

• Conditions: Cerebral Angiography; Heparinization
• Interventions: Drug: Heparin Sodium Injection; Other: No heparinization; Drug: Heparin

• Registration Number: NCT06365398
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2018-03
• Primary Completion: 2021-06-01
• Study Completion: 2022-01-01
• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-04-12
• Last Update Submitted: 2024-04-12
• Study First Posted: 2024-04-15
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Micro-dose group	Heparin Sodium Injection	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.
heparinization group	No heparinization	No heparinization is performed with no additional heparin is administered by a sheath or arterial route in the third group.
Regular-dose group	Heparin	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.

Primary Outcome Measures

Name	Time	Method
postoperative cerebral infarction	Perioperative period	The safety endpoints of the study were postoperative cerebral infarction on imaging, and local complications such as bleeding at the puncture site, subcutaneous hematoma, and pseudoaneurysm diagnosed by computed tomography angiography (CTA). All patients underwent magnetic resonance imaging within 48 hours after cerebral angiography to check for new ischemic infarction. Postoperative ischemia was characterized as the abrupt appearance of novel neurological deficits, including hemiplegia, hemianopia, aphasia, dysphagia, sensory impairment, or confusion, persisting for more than 24 hours, accompanied with the presence of newly detected cerebral infarction using diffusion-weighted magnetic resonance imaging or computed tomography.

Secondary Outcome Measures

Name	Time	Method
the incidence of pain of surgical limb	24 hours after intervention	the incidence of pain of surgical limb is assessed after intervention
the incidence of postoperative urethral catheterization	24 hours after intervention	the incidence of postoperative urethral catheterization is assessed after intervention.
the incidence of paralysis of surgical limb	24 hours after intervention	the incidence of paralysis is assessed after intervention
Numerical Rating Scale (NRS) for back pain	24 hours after intervention	Numerical Rating Scale (NRS) for back pain is assessed by investigators after intervention

Trial Locations

Locations (2)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Xuanwu Hospital, Capital Medical University.; 🇨🇳 Beijing, China