NCT04561648

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,988

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 11, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

5.3 years

First QC Date

September 11, 2020

Last Update Submit

February 17, 2024

Conditions

Radial Artery Occlusion

Keywords

Radial Artery OcclusionPercutaneous coronary interventionTransradial accessUnfractionated HeparinCoronary angiography

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Time to hemostasis.

    24 hours.

  • Diameters of the radial artery.

    24 hours.

  • Correlation of RAO by oximetric plethysmography and DUS.

    30 days.

  • Hemorrhagic Complications.

    30 days.

  • Hemorrhagic Complications.

    24 hours.

Study Arms (2)

High Dose of Unfractionated Heparin

EXPERIMENTAL

100 IU/Kg of Unfractionated Heparin

Drug: Unfractionated Heparin

Standard Dose of Unfractionated Heparin

ACTIVE COMPARATOR

5000 IU of Unfractionated Heparin.

Drug: Unfractionated Heparin

Interventions

Unfractionated HeparinDRUG

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.

High Dose of Unfractionated HeparinStandard Dose of Unfractionated Heparin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18 years of age, both genders.
  • Successful transradial acess for an elective diagnostic coronary angiography.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Cardiología Ignacio Chávez

Mexico City, Tlalpan, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

Arterial Occlusive Diseases

Interventions

Heparin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Guering Eid Lidt, M.D.

    Instituto Nacional de Cardiología Ignacio Chávez

    STUDY DIRECTOR

  • Julio I Farjat Pasos, M.D.

    Instituto Nacional de Cardiología Ignacio Chávez

    PRINCIPAL INVESTIGATOR

  • Carlos Aguila Bravo, M.D.

    Instituto Nacional de Cardiología Ignacio Chávez

    PRINCIPAL INVESTIGATOR

  • Monserrat Villalobos Pedroza, M.D.

    Instituto Nacional de Cardiología Ignacio Chávez

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Monserrat Villalobos Pedroza, M.D.

CONTACT

55 5573 2911movspa@hotmail.com

Guering Eid Lidt, M.D.

CONTACT

55 5573 2911guering@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Investigator

Study Record Dates

First Submitted

September 11, 2020

First Posted

September 23, 2020

Study Start

August 1, 2020

Primary Completion

December 1, 2025

Study Completion

March 1, 2026

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

The individual patient data will not be shared with other researchers.

Locations

ME(1)