MULTICENTER, DOUBLE BLIND CLINICAL TRIAL TO EVALUATE THE ANTIHEMORRAGIC EFFECT OF THE TOPICAL TRANEXAMIC ACID DURING PACEMAKER IN ANTICOAGULATED PATIENTS

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520929-20-00

Acronym

HTAJ-TRANEX-2019-01

Enrollment

100

Registered

2025-01-30

Start date

Unknown

Completion date

Unknown

Last updated

2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PACEMAKER IN ANTICOAGULATED PATIENTS

Brief summary

Evaluation of hemorrhage and/or hematoma in patients anticoagulated with acenocoumarol after pacemaker implantation and the effect of tranexamic acid (TXA) to reduce these events.

Detailed description

Assess the occurrence of the following events: • Infectious complications • Duration of the procedure • Hospital stay • Need for blood products • Need for prohemostatic drugs • Thrombotic complications

Interventions

DRUGAmchafibrin 500 mg solución inyectable

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Evaluation of hemorrhage and/or hematoma in patients anticoagulated with acenocoumarol after pacemaker implantation and the effect of tranexamic acid (TXA) to reduce these events.	—

Secondary

Measure	Time frame
Assess the occurrence of the following events: • Infectious complications • Duration of the procedure • Hospital stay • Need for blood products • Need for prohemostatic drugs • Thrombotic complications	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026