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

NCT ID: NCT06365398

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2022-01-01

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.

Conditions

Cerebral Angiography; Heparinization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Regular-dose group

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.

Group Type: ACTIVE_COMPARATOR

Heparin

Intervention Type: DRUG

As soon as the sheath was inserted, three different doses of heparin were administered according to the patients group assignment. In the conventional systemic heparinization (Regular-dose) group (The drug is Heparin Sodium Injection 2ml:12500 Units per bottle), systemic heparin was administered by intravenous injection at a dose of 83 Units/Kg. Patients in both the regular dose (83 units/kg) and low dose (42 units/kg) groups were given heparin intravenously once before the procedure of cerebral angiography, and no further heparin infusion was given during the angiography procedure. If the duration of the imaging procedure exceeded 1 hour, an additional 1/2 amount of the first dose of heparin was given.

Micro-dose group

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.

Group Type: EXPERIMENTAL

Heparin Sodium Injection

Intervention Type: DRUG

In the micro-dose systemic heparinization (Micro-dose) group (the drug is Heparin Sodium Injection 2ml:12500 Units per bottle), systemic heparin was administered by intravenous injection at a dose of 42 Units/Kg. Patients in both the regular dose (83 units/kg) and low dose (42 units/kg) groups were given heparin intravenously once before the procedure of cerebral angiography, and no further heparin infusion was given during the angiography procedure. If the duration of the imaging procedure exceeded 1 hour, an additional 1/2 amount of the first dose of heparin was given.

heparinization group

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

Group Type: EXPERIMENTAL

No heparinization

Intervention Type: OTHER

No additional heparin was administered via the sheath or arterial route in the no heparinization group.

Interventions

Heparin

As soon as the sheath was inserted, three different doses of heparin were administered according to the patients group assignment. In the conventional systemic heparinization (Regular-dose) group (The drug is Heparin Sodium Injection 2ml:12500 Units per bottle), systemic heparin was administered by intravenous injection at a dose of 83 Units/Kg. Patients in both the regular dose (83 units/kg) and low dose (42 units/kg) groups were given heparin intravenously once before the procedure of cerebral angiography, and no further heparin infusion was given during the angiography procedure. If the duration of the imaging procedure exceeded 1 hour, an additional 1/2 amount of the first dose of heparin was given.

Intervention Type: DRUG

Heparin Sodium Injection

In the micro-dose systemic heparinization (Micro-dose) group (the drug is Heparin Sodium Injection 2ml:12500 Units per bottle), systemic heparin was administered by intravenous injection at a dose of 42 Units/Kg. Patients in both the regular dose (83 units/kg) and low dose (42 units/kg) groups were given heparin intravenously once before the procedure of cerebral angiography, and no further heparin infusion was given during the angiography procedure. If the duration of the imaging procedure exceeded 1 hour, an additional 1/2 amount of the first dose of heparin was given.

Intervention Type: DRUG

No heparinization

No additional heparin was administered via the sheath or arterial route in the no heparinization group.

Intervention Type: OTHER

Other Intervention Names

Regular-dose heparinization; Micro-dose heparinization

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Xuanwu Hospital, Capital Medical University.

Beijing, , China

Countries

China

Other Identifiers

XWHL-2018010

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SELECT

Identifier Type: -

Identifier Source: org_study_id