NCT02570243

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,800 (actual)
• Sponsor: University of Patras · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Coronary Angiography

Interventions

Type	Name	Description
DRUG	High dose of Unfractionated Heparin	Unfractionated Heparin 100IU/Kg
DRUG	Standard dose of Unfractionated heparin	Unfractionated heparin 50IU/Kg

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2015-10-07
• Last updated: 2017-09-19

Locations

1 site across 1 country: Greece