NCT04561648

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,988 (estimated)
• Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radial Artery Occlusion

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-08-01
• Primary completion: 2025-12-01
• Completion: 2026-03-01
• First posted: 2020-09-23
• Last updated: 2024-02-20

Locations

1 site across 1 country: Mexico