Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 21 of 989 for:    Heparin sodium

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02570243
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Dimitrios Alexopoulos, 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).


Condition or disease Intervention/treatment Phase
Coronary Angiography Drug: High dose of Unfractionated Heparin Drug: Standard dose of Unfractionated heparin Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High (100IU/Kg) Versus Standard (50IU/Kg) Heparin Dose for Prevention of Forearm Artery Occlusion Forearm Artery Occlusion
Study Start Date : February 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Active Comparator: Standard dose of Heparin
50IU/Kg heparin intravenously
Drug: Standard dose of Unfractionated heparin
Unfractionated heparin 50IU/Kg

Experimental: High dose of Heparin
100IU/Kg heparin intravenously
Drug: High dose of Unfractionated Heparin
Unfractionated Heparin 100IU/Kg




Primary Outcome Measures :
  1. Radial artery occlusion [ Time Frame: 30 days ]
    Radial artery occlusion as assessed by Doppler Ultrasound


Secondary Outcome Measures :
  1. Large local hematomas of the forearm [ Time Frame: 30 days ]
    large local hematomas of the forearm (defined as those extending beyond the forearm)

  2. Major bleeding [ Time Frame: 30 days ]
    ≥ 5g/dL decrease in hemoglobin or ≥15% decrease in hematocrit or any life-threatening bleeding (confirmed by MRI or computed tomography)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570243


Locations
Layout table for location information
Greece
Patras University Hospital
Patras, Rion, Greece, 26500
Sponsors and Collaborators
University of Patras

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dimitrios Alexopoulos, Professor of Cardiology, University of Patras
ClinicalTrials.gov Identifier: NCT02570243     History of Changes
Other Study ID Numbers: PATRASCARDIOLOGY 20
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017

Keywords provided by Dimitrios Alexopoulos, University of Patras:
heparin
radial artery

Additional relevant MeSH terms:
Layout table for MeSH terms
Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action