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

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ClinicalTrials.gov Identifier: NCT04561648
Recruitment Status : Recruiting
First Posted : September 23, 2020
Last Update Posted : March 10, 2022
Sponsor:
Information provided by (Responsible Party):
Julio Ivan Farjat Pasos, Instituto Nacional de Cardiologia Ignacio Chavez

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Radial Artery Occlusion Drug: Unfractionated Heparin Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1988 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients that are planned to go to an invasive coronary artery angiography with good radial pulse and using the TRA are going to be randomized to two groups. One will receive the standard UFH dose and the other will receive the prespecified high dose (per Kg of body weight) of UFH.
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Standard vs High Dose of Unfractionated Heparin in the Incidence of Radial Artery Occlusion (DEFINITION) Trial.
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arms and Interventions
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Arm Intervention/treatment
Experimental: High Dose of Unfractionated Heparin
100 IU/Kg of Unfractionated Heparin
 Drug: 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.
Active Comparator: Standard Dose of Unfractionated Heparin
5000 IU of Unfractionated Heparin.
 Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Radial artery occlusion (RAO). [ Time Frame: 24 hours. ]
    The incidence of RAO (with DUS and plethysmography).

  2. Radial artery occlusion (RAO). [ Time Frame: 30 days. ]
    The incidence of RAO (with DUS and plethysmography).


Secondary Outcome Measures :
  1. Time to hemostasis. [ Time Frame: 24 hours. ]
    Time to hemostasis, from the removal of the introducer sheath to hemostasis.

  2. Diameters of the radial artery. [ Time Frame: 24 hours. ]
    Minimum, maximum and mean diameters of the radial artery by vascular ultrasound.

  3. Correlation of RAO by oximetric plethysmography and DUS. [ Time Frame: 30 days. ]
    Correlation of plethysmography and DUS for the determination of RAO.

  4. Hemorrhagic Complications. [ Time Frame: 30 days. ]

    Compare the incidence of bleeding complications according to The Bleeding Academic Research Consortium 2 (BARC-2) scale:

    The BARC-2 scale:

    • Type 0
    • Type 1
    • Type 2
    • Type 3
    • Type 4
    • Type 5

  5. Hemorrhagic Complications. [ Time Frame: 24 hours. ]

    Compare the incidence of bleeding complications according to the Early Discharge After Transradial Stenting of Coronary Arteries Study (EASY) scale:

    The EASY scale:

    • Grade I
    • Grade II
    • Grade III
    • Grade IV
    • Grade V


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

Inclusion Criteria:

  • 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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04561648


Contacts
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Contact: Julio I Farjat Pasos, M.D. 55 5573 2911 ext 21217 julio.farjat@gmail.com
Contact: Guering Eid Lidt, M.D. 55 5573 2911 ext 21217 guering@yahoo.com

Locations
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Mexico
Instituto Nacional de Cardiología Ignacio Chávez Recruiting
Mexico City, Tlalpan, Mexico, 14080
Contact: Julio I Farjat Pasos, M.D.    55 5573 2911 ext 21217    julio.farjat@gmail.com   
Contact: Guering Edit Lid, M.D.    55 5573 2911 ext 21217    guering@yahoo.com   
Sub-Investigator: Carlos A Aguila Bravo, M.D.         
Sub-Investigator: Diana I Becerril Lechuga, M.D.         
Sub-Investigator: Kathia E Estrada López, M.D.         
Sub-Investigator: María E Soto López, M.D.         
Sub-Investigator: Jorge Gaspar, M.D         
Sponsors and Collaborators
Instituto Nacional de Cardiologia Ignacio Chavez
Investigators
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Principal Investigator: Julio I Farjat Pasos, M.D. Instituto Nacional de Cardiología Ignacio Chávez
Study Director: Guering Eid Lidt, M.D. Instituto Nacional de Cardiología Ignacio Chávez
More Information
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Responsible Party: Julio Ivan Farjat Pasos, Principal Investigator, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier: NCT04561648    
Other Study ID Numbers: INCAR-DG-DI-205-2020
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The individual patient data will not be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julio Ivan Farjat Pasos, Instituto Nacional de Cardiologia Ignacio Chavez:
Radial Artery Occlusion
Percutaneous coronary intervention
Transradial access
Unfractionated Heparin
Coronary angiography
Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heparin
Calcium heparin
 Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action