High (100IU/Kg) Versus Standard (50IU/Kg) Heparin Dose for Prevention of Forearm Artery Occlusion

Phase 4

Completed

• Conditions: Coronary Angiography
• Interventions: Drug: Standard dose of Unfractionated heparin; Drug: High dose of Unfractionated Heparin

• Registration Number: NCT02570243
• Lead Sponsor: University of Patras

Brief Summary

This is a prospective, multi-center, superiority study of parallel design. Patients are enrolled if they are older than 18 years old, are scheduled for 5 or 6 Fr diagnostic coronary angiography and the interventional cardiologist is willing to proceed with radial access. Patients are randomized before diagnostic catheterization to receive intravenously either 100IU/Kg or 50 IU/Kg of unfractionated heparin (UFH) in a 1:1 ratio. Patients are discharged usually within 4 to 6 hours after coronary angiography.

Radial artery in each patient is evaluated either in-hospital or during a subsequent visit by one physician who is blinded to the actual antithrombotic treatment given. Radial artery is considered occluded if it exhibits ultrasonographically no antegrade flow signal both at baseline and after reevaluation on a second occasion, within 30 days after the index procedure. Initially patent arteries will not be reexamined and are thought to remain permanently patent. The investigators also monitor major bleeding (defined as ≥ 5g/dL decrease in hemoglobin or ≥15% decrease in hematocrit or any life-threatening bleeding (confirmed by MRI or computed tomography) and large local hematomas of the forearm (defined as those extending beyond the forearm).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-10-05
• Study First Submitted QC: 2015-10-06
• Study First Posted: 2015-10-07
• Status Verified: 2017-09
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Last Update Submitted: 2017-09-17
• Last Update Posted: 2017-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

• Older than 18 years old
• Scheduled for 5 or 6 Fr diagnostic coronary angiography
• The interventional cardiologist is willing to proceed with radial access
• Written informed consent

Exclusion Criteria

Before randomization

• chronic hemodialysis
• oral anticoagulation
• hemodynamic instability
• severe dermo-myoskeletal forearm deformities
• history of CABG and bilateral use of either the internal mammary or radial artery
• history of CABG and ipsilateral use of both the internal mammary and radial artery
• admission for elective PCI After randomization
• crossover to another arterial access site is required
• ad hoc PCI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard dose of Heparin	Standard dose of Unfractionated heparin	50IU/Kg heparin intravenously
High dose of Heparin	High dose of Unfractionated Heparin	100IU/Kg heparin intravenously

Primary Outcome Measures

Name	Time	Method
Radial artery occlusion	30 days	Radial artery occlusion as assessed by Doppler Ultrasound

Secondary Outcome Measures

Name	Time	Method
Major bleeding	30 days	≥ 5g/dL decrease in hemoglobin or ≥15% decrease in hematocrit or any life-threatening bleeding (confirmed by MRI or computed tomography)
Large local hematomas of the forearm	30 days	large local hematomas of the forearm (defined as those extending beyond the forearm)

Trial Locations

Locations (1)

Patras University Hospital; 🇬🇷 Patras, Rion, Greece