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

NCT06365398 | Completed Phase 4 DMC

• 2 other identifiers: SELECTXWHL-2018010
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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

Keywords

cerebral angiography; heparin; Nursing; Ischemic Stroke; Safety; Efficacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Numerical Rating Scale (NRS) for back pain

  24 hours after intervention

• the incidence of paralysis of surgical limb

  24 hours after intervention

• the incidence of pain of surgical limb

  24 hours after intervention

• the incidence of postoperative urethral catheterization

  24 hours after intervention

Study Arms (3)

Regular-dose group

ACTIVE COMPARATOR

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

Micro-dose group

EXPERIMENTAL

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

heparinization group

EXPERIMENTAL

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

Other: No heparinization

Interventions

Heparin 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.

Also known as: Regular-dose heparinization

Regular-dose group

Heparin Sodium Injection 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.

Also known as: Micro-dose heparinization

Micro-dose group

No heparinization OTHER

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

heparinization group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• iodine allergy;
• hepatic and/or renal insufficiency;
• severe hypertension with poor blood pressure control;
• hemorrhagic diseases;
• hyperlipidemia;
• poor glycemic control in diabetes;
• pregnancy;
• atrial fibrillation;
• undergoing interventional treatment simultaneously.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (2)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Xuanwu Hospital, Capital Medical University.

Beijing, 100053, China

Location

Related Publications (1)

• Wang Z, Luo J, Qin Q, Tang H, Yao H, Wang T, Feng F, Li W, Sun M, Jiao L. Safety and efficacy of low dose or no heparinization in cerebral angiography: A randomized controlled study (SELECT trial). Brain Circ. 2024 Sep 13;11(4):301-308. doi: 10.4103/bc.bc_41_24. eCollection 2025 Oct-Dec.

  PMID: 41531874 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Heparin

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients enrolled are randomly divided into three groups according to the random number principle, which includes conventional systemic heparinization group, micro-dose systemic heparinization, and heparin-free angiography. It is carried out with a 1:1:1 ratio and variable block sizes.

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 15, 2024
• Study Start: January 1, 2018
• Primary Completion: June 1, 2021
• Study Completion: January 1, 2022
• Last Updated: April 15, 2024

Record last verified: 2018-03

Locations

CN (2)