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OpenTrials
Completed

NCT Number: NCT02570243

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Patras University Hospital

Pátrai, Rion, 26500, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High dose of Unfractionated Heparin

Drug

Unfractionated Heparin 100IU/Kg

Standard dose of Unfractionated heparin

Drug

Unfractionated heparin 50IU/Kg

Primary outcomes

  1. Radial artery occlusion

    Time frame: 30 days

    Radial artery occlusion as assessed by Doppler Ultrasound

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 7, 2015
Registry last updated
Sep 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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