Standard vs High Dose of Unfractionated Heparin in the Incidence of Radial Artery Occlusion (DEFINITION) Trial. (DEFINITION)
-
- STATUS
- Recruiting
-
- End date
- Aug 1, 2024
-
- participants needed
- 1988
-
- sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
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.
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.
Details
| Condition | Radial Artery Occlusion |
|---|---|
| Treatment | Unfractionated heparin |
| Clinical Study Identifier | NCT04561648 |
| Sponsor | Instituto Nacional de Cardiologia Ignacio Chavez |
| Last Modified on | 21 October 2022 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer