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

Coronary Angiography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02570243
• Other study ID #: PATRASCARDIOLOGY 20
• Status: Completed
• Phase: Phase 4
• First received: October 5, 2015
• Last updated: September 17, 2017
• Start date: February 2015
• Est. completion date: September 2017

Study information

• Verified date: September 2017
• Source: University of Patras
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Angiography

Intervention

Drug:
• High dose of Unfractionated Heparin
Unfractionated Heparin 100IU/Kg
• Standard dose of Unfractionated heparin
Unfractionated heparin 50IU/Kg

Locations

Country	Name	City	State
Greece	Patras University Hospital	Patras	Rion

Sponsors (1)

Lead Sponsor	Collaborator
University of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radial artery occlusion	Radial artery occlusion as assessed by Doppler Ultrasound	30 days
Secondary	Large local hematomas of the forearm	large local hematomas of the forearm (defined as those extending beyond the forearm)	30 days
Secondary	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