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

Cerebral Angiography Clinical Trial

— SELECT  

Official title:

Safety and Efficacy of Low-dose Heparinization in Cerebral Angiography: a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06365398
• Other study ID #: SELECT
• Secondary ID: XWHL-2018010
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2018
• Est. completion date: January 1, 2022

Study information

• Verified date: March 2018
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 1, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Angiography

Intervention

Drug:
• 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.
• 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.

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

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing
China	Xuanwu Hospital, Capital Medical University.	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative cerebral infarction	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.	Perioperative period
Secondary	Numerical Rating Scale (NRS) for back pain	Numerical Rating Scale (NRS) for back pain is assessed by investigators after intervention	24 hours after intervention
Secondary	the incidence of paralysis of surgical limb	the incidence of paralysis is assessed after intervention	24 hours after intervention
Secondary	the incidence of pain of surgical limb	the incidence of pain of surgical limb is assessed after intervention	24 hours after intervention
Secondary	the incidence of postoperative urethral catheterization	the incidence of postoperative urethral catheterization is assessed after intervention.	24 hours after intervention