TRIAL TO EVALUATE THE ANTIHEMORRAGIC EFFECT OF THE TOPICAL TRANEXAMIC ACID DURING PACEMAKER IN ANTICOAGULATED PATIENTS

Phase 1

• Conditions: Pacemaker implant for anticoagulated patients; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-002118-37-ES
• Lead Sponsor: Rafael Blancas-Gómez Casero

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-20
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

All patients undergoing implantation of definitive pacemakers, older than 18 years of age, who give their consent and receive anticoagulant therapy with acenocoumarol prior to the procedure
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

• Under 18
• Use of antiaggregant other than aspirin in the 5 days prior to implantation
• INR> 3.5 or INR <2
• Denial of informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified