Heparin for RAO Post-Transradial Angiography in AIS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-04

Study Completion Date

2026-05-31

Brief Summary

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Cerebral angiography is a critical diagnostic tool in neurology, serving as the "gold standard" for evaluating cerebrovascular stenosis, hemodynamics, aneurysms, and arteriovenous malformations. Compared to the traditional transfemoral approach, transradial cerebral angiography (TRA) offers advantages such as preserved patient privacy, immediate post-procedure mobility, shorter hospitalization, and fewer access-site complications. Consequently, TRA has gained increasing acceptance among patients and clinicians as the preferred vascular access . However, radial artery occlusion (RAO) remains a common complication post-TRA, with reported incidence rates varying widely (1%-33%). RAO is particularly concerning as the radial artery serves as a key access for both cardiac and neurovascular interventions; its occlusion limits future procedural options.Evidence from interventional cardiology suggests that intra-arterial heparin administration significantly reduces RAO risk.However, patients undergoing transradial cerebral angiography are predominantly those with cerebrovascular diseases, including acute ischemic stroke (AIS)-a population at potential risk for hemorrhagic transformation.Although the 2022 Chinese Expert Consensus on Neurointerventional Diagnosis and Treatment via Transradial Access recommends intra-sheath heparin injection to prevent RAO, this recommendation is largely extrapolated from coronary intervention data. While several studies indicate that low-dose heparin is safe in moderate-to-severe AIS patients without increasing intracranial hemorrhage risk , high-level evidence specific to neurointerventional procedures-particularly in AIS patients-remains lacking.This multicenter, double-blind, randomized controlled trial (RCT) aims to: Evaluate the efficacy of intra-arterial heparin in preventing RAO following TRA cerebral angiography.Assess the safety of heparin in AIS patients, with a focus on hemorrhagic complications. By addressing these questions, the study will provide evidence-based guidance to optimize TRA outcomes, balancing RAO prevention with bleeding risk in neurovascular interventions. Its findings hold significant clinical value for improving the safety and efficacy of transradial cerebral angiography.

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Detailed Description

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Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Heparin Group

Inject 2,500 units (2mL) of unfractionated heparin intra-arterially via sheath prior to angiography

Group Type EXPERIMENTAL

Heparin - Therapeutic dosage

Intervention Type DRUG

Intra-arterial sheath injection of heparin 2500 units before operation

Saline (0.9% NaCl)

Inject 2ml saline intra-arterially via sheath prior to angiography

Group Type PLACEBO_COMPARATOR

Saline (0.9% NaCl)

Intervention Type DRUG

Intra-arterial sheath injection of 2mL saline (0.9% sodium chloride)

Interventions

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Heparin - Therapeutic dosage

Intra-arterial sheath injection of heparin 2500 units before operation

Intervention Type DRUG

Saline (0.9% NaCl)

Intra-arterial sheath injection of 2mL saline (0.9% sodium chloride)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years
2. Acute ischemic stroke onset within 7 days (inclusive)
3. Patients undergoing cerebral angiography via transradial approach
4. Participant or legal representative capable of providing informed consent

Exclusion Criteria

1. Current anticoagulation therapy prior to procedure
2. Positive modified Allen's test result
3. History of coronary artery bypass grafting(CABG) with missing right radial artery graft
4. Severe forearm deformities (skin/musculoskeletal) or failed radial artery sheath placement
5. Suspected/confirmed pregnancy or lactation
6. Acute ischemic stroke with hemorrhagic transformation
7. Active systemic bleeding
8. Renal insufficiency (eGFR \<30 mL/min or serum creatinine \>200 μmol/L)
9. Investigator-determined ineligibility for trial participation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No