Heparin for RAO Post-Transradial Angiography in AIS

Not Applicable

Recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Heparin - Therapeutic dosage; Drug: Saline (0.9% NaCl)

• Registration Number: NCT07162064
• Lead Sponsor: Xiang Luo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-04
• Study First Submitted: 2025-08-26
• Study First Submitted QC: 2025-09-07
• Last Update Submitted: 2025-09-07
• Study First Posted: 2025-09-09
• Last Update Posted: 2025-09-09
• Primary Completion: 2026-03-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 440

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heparin Group	Heparin - Therapeutic dosage	Inject 2,500 units (2mL) of unfractionated heparin intra-arterially via sheath prior to angiography
Saline (0.9% NaCl)	Saline (0.9% NaCl)	Inject 2ml saline intra-arterially via sheath prior to angiography

Primary Outcome Measures

Name	Time	Method
24 hours radial artery occlusion rate after operation	24 hours±12hours	Radial artery occlusion rate was assessed by ultrasonography 24 hours±12hours after the procedure.

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, China