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

Study Overview
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Brief Summary
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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).

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

Conditions
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Coronary Angiography

Intervention / Treatment
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* Drug: High dose of Unfractionated Heparin
* Drug: Standard dose of Unfractionated heparin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard dose of Heparin<br>50IU/Kg heparin intravenously | Drug: Standard dose of Unfractionated heparin<br>* Unfractionated heparin 50IU/Kg<br>|
| Experimental: High dose of Heparin<br>100IU/Kg heparin intravenously | Drug: High dose of Unfractionated Heparin<br>* Unfractionated Heparin 100IU/Kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radial artery occlusion | Radial artery occlusion as assessed by Doppler Ultrasound | 30 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heparin, radial artery