Standard vs High Dose of Unfractionated Heparin in the Incidence of Radial Artery Occlusion (DEFINITION) Trial.

  • STATUS
    Recruiting
  • End date
    Apr 1, 2022
  • participants needed
    1988
  • sponsor
    Instituto Nacional de Cardiologia Ignacio Chavez
Updated on 25 January 2021

Summary

Double blind single center clinical trial to compare the incidence of radial artery occlusion (RAO) using standard doses of Unfractionated Heparin (UFH) vs. high doses of UFH.

Description

Radial artery occlusion (RAO) is one of the most common complications in transradial artery interventions (up to 30% of cases if specific measures are not taken to prevent it) and is related to the prothrombotic state of the patient, the scarce distal flow to the access site and the trauma caused to the artery during the procedure.

Currently worldwide, the transradial (TRA) access is the most widely used access for coronary angiography (in up to 90% of the procedures) because the transradial approach is associated with lower rates of vascular complications and event mortality (compared to the femoral access).

Although TRA access is safer, it is not free of complications, being one of the most important the RAO.

There are universal efforts to reduce RAO improving every aspects of the technique, from the type of introducer to the hemostasis time to a distal TRA, with evidence suggesting that higher doses of UFH can also decrease RAO to a greater extent. The decrease in the incidence of RAO have been proposed to be up to 2.8 times with high doses of UFH (single-center, retrospective study that compared regular not standard doses of UFH versus higher doses of UFH) although no proper prospective clinical trial have been undertaken to prove this.

The standard dose that has shown a lower rate of RAO is 5000 IU, which will be compared with 100 IU / Kg of UFH, with a randomized, prospective, double-blind design, with short-term (24-hour) follow-up with Doppler ultrasound (DUS) and its correlation with plethysmography to document RAO, and in occluded arteries, there will be a 30-day follow-up to determine the recanalization (or persistent occlusion) rates by DUS (and plethysmography). In order to address safety concerns of higher UFH doses, all the potential hemorrhagic complications will be evaluated during the study follow-up time and higher hemorrhagic risk patients are going to be excluded.

Details
Condition Radial Artery Occlusion
Treatment Unfractionated heparin
Clinical Study IdentifierNCT04561648
SponsorInstituto Nacional de Cardiologia Ignacio Chavez
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Radial Artery Occlusion?
Do you have any of these conditions: Do you have Radial Artery Occlusion??
Patients over 18 years of age, both genders
Successful transradial acess for an elective diagnostic coronary angiography

Exclusion Criteria

Weight <50 Kg
Puncture of the ipsilateral radial artery in the last month
Still ongoing effect of pre-procedural recently used oral anticoagulants
Use of enoxaparin in the past in the last 12 hours prior to the procedure
Use of unfractionated heparin in the last 6 hours prior the procedure
Alterations in coagulation or platelets prone to bleeding or thrombotic complications
Anatomical alterations at the radial access site or radial artery
Arteriovenous fistula in the ipsilateral arm
History of major bleeding associated with the use of UFH
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