Standard vs High Dose of Unfractionated Heparin in the Incidence of Radial Artery Occlusion (DEFINITION) Trial.
NCT ID: NCT04561648
Last Updated: 2024-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1988 participants
INTERVENTIONAL
2020-08-01
2026-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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High Dose of Unfractionated Heparin
100 IU/Kg of Unfractionated Heparin
Unfractionated Heparin
Before removing the introducer sheath, the 2nd operator will pass the missing UFH dose to the first operator to reach 100 IU per kg of body weight in a 10 ml syringe mixed with 0.9% saline solution. The blinded first operator will administer this without knowing if it is saline or the supplemental dose of unfractionated heparin.
Standard Dose of Unfractionated Heparin
5000 IU of Unfractionated Heparin.
Unfractionated Heparin
Before removing the introducer sheath, the 2nd operator will pass the missing UFH dose to the first operator to reach 100 IU per kg of body weight in a 10 ml syringe mixed with 0.9% saline solution. The blinded first operator will administer this without knowing if it is saline or the supplemental dose of unfractionated heparin.
Interventions
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Unfractionated Heparin
Before removing the introducer sheath, the 2nd operator will pass the missing UFH dose to the first operator to reach 100 IU per kg of body weight in a 10 ml syringe mixed with 0.9% saline solution. The blinded first operator will administer this without knowing if it is saline or the supplemental dose of unfractionated heparin.
Eligibility Criteria
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Inclusion Criteria
* Successful transradial acess for an elective diagnostic coronary angiography.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Instituto Nacional de Cardiologia Ignacio Chavez
OTHER
Responsible Party
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Julio Ivan Farjat Pasos
Co-Investigator
Principal Investigators
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Guering Eid Lidt, M.D.
Role: STUDY_DIRECTOR
Instituto Nacional de Cardiología Ignacio Chávez
Julio I Farjat Pasos, M.D.
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Cardiología Ignacio Chávez
Carlos Aguila Bravo, M.D.
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Cardiología Ignacio Chávez
Monserrat Villalobos Pedroza, M.D.
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Cardiología Ignacio Chávez
Locations
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Instituto Nacional de Cardiología Ignacio Chávez
Mexico City, Tlalpan, Mexico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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INCAR-DG-DI-205-2020
Identifier Type: -
Identifier Source: org_study_id
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