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

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Angiography; Heparinization
• Intervention / Treatment: Drug: Heparin; Drug: Heparin Sodium Injection; Other: No heparinization

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100053
    • Xuanwu Hospital, Capital Medical University.
  • Beijing
    • Beijing, Beijing, China
      • Xuanwu Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.; Other Names: Regular-dose heparinization
Experimental: 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.	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.; Other Names: Micro-dose heparinization
Experimental: heparinization group; No heparinization is performed with no additional heparin is administered by a sheath or arterial route in the third group.	Other: No heparinization; No additional heparin was administered via the sheath or arterial route in the no heparinization group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Estimated): April 15, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Nursing; Ischemic Stroke; heparin; cerebral angiography
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: SELECT (Other Identifier: Folktandvården Stockholms län AB); XWHL-2018010 (Other Grant/Funding Number: Xuanwu Hospital, Capital Medical University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No