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

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.

Study Overview

• Status: Recruiting
• Conditions: Radial Artery Occlusion
• Intervention / Treatment: Drug: Unfractionated Heparin

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 Type: Interventional
• Enrollment (Estimated): 1988
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Monserrat Villalobos Pedroza, M.D.; Phone Number: 21217 55 5573 2911; Email: movspa@hotmail.com
• Study Contact Backup: Name: Guering Eid Lidt, M.D.; Phone Number: 21217 55 5573 2911; Email: guering@yahoo.com

Study Locations

• Mexico
  • Tlalpan
    • Mexico City, Tlalpan, Mexico, 14080
      • Recruiting
      • Instituto Nacional de Cardiología Ignacio Chavez
      • Contact: Monserrat Villalobos, M.D.; Phone Number: 21217 55 5573 2911; Email: movspa@hotmail.com
      • Contact: Guering Edit Lid, M.D.; Phone Number: 21217 55 5573 2911; Email: guering@yahoo.com
      • Sub-Investigator: Carlos A Aguila Bravo, M.D.
      • Sub-Investigator: María E Soto López, M.D.
      • Sub-Investigator: Jorge Gaspar, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radial artery occlusion (RAO).	The incidence of RAO (with DUS and plethysmography).	24 hours.
Radial artery occlusion (RAO).	The incidence of RAO (with DUS and plethysmography).	30 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to hemostasis.	Time to hemostasis, from the removal of the introducer sheath to hemostasis.	24 hours.
Diameters of the radial artery.	Minimum, maximum and mean diameters of the radial artery by vascular ultrasound.	24 hours.
Correlation of RAO by oximetric plethysmography and DUS.	Correlation of plethysmography and DUS for the determination of RAO.	30 days.
Hemorrhagic Complications.	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	30 days.
Hemorrhagic Complications.	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	24 hours.

Collaborators and Investigators

• Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
• Investigators: Study Director: Guering Eid Lidt, M.D., Instituto Nacional de Cardiología Ignacio Chavez; Principal Investigator: Julio I Farjat Pasos, M.D., Instituto Nacional de Cardiología Ignacio Chavez; Principal Investigator: Carlos Aguila Bravo, M.D., Instituto Nacional de Cardiología Ignacio Chavez; Principal Investigator: Monserrat Villalobos Pedroza, M.D., Instituto Nacional de Cardiología Ignacio Chavez

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: September 19, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 17, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Transradial access; Coronary angiography; Percutaneous coronary intervention; Radial Artery Occlusion; Unfractionated Heparin
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: INCAR-DG-DI-205-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual patient data will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No