Clinical trial NCT04561648: Standard vs High Dose of Unfractionated Heparin in the Incidence of Radial Artery Occlusion (DEFINITION) Trial.
Official title: Standard vs High Dose of Unfractionated Heparin in the Incidence of Radial Artery Occlusion (DEFINITION) Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Radial Artery Occlusion
Keywords: Radial Artery Occlusion
Percutaneous coronary intervention
Transradial access
Unfractionated Heparin
Coronary angiography
Lead sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 1988
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Radial artery occlusion (RAO).
timeFrame: 24 hours.
measure: Radial artery occlusion (RAO).
timeFrame: 30 days.
Secondary outcomes:
measure: Time to hemostasis.
timeFrame: 24 hours.
measure: Diameters of the radial artery.
timeFrame: 24 hours.
measure: Correlation of RAO by oximetric plethysmography and DUS.
timeFrame: 30 days.
measure: Hemorrhagic Complications.
timeFrame: 30 days.
measure: Hemorrhagic Complications.
timeFrame: 24 hours.
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cardiología Ignacio Chávez
state: Tlalpan
Study officials:
affiliation: Instituto Nacional de Cardiología Ignacio Chávez
name: Guering Eid Lidt, M.D.
role: STUDY_DIRECTOR
affiliation: Instituto Nacional de Cardiología Ignacio Chávez
name: Julio I Farjat Pasos, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Cardiología Ignacio Chávez
name: Carlos Aguila Bravo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Cardiología Ignacio Chávez
name: Monserrat Villalobos Pedroza, M.D.
role: PRINCIPAL_INVESTIGATOR
References: