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Clinical Trials/EUCTR2019-002118-37-ES
EUCTR2019-002118-37-ES
Active, not recruiting
Phase 1

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

Rafael Blancas-Gómez Casero0 sites100 target enrollmentDecember 20, 2019
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DrugsAmchafibrin

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Rafael Blancas-Gómez Casero
Enrollment
100
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 20, 2019
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Rafael Blancas-Gómez Casero

Eligibility Criteria

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

  • •Use of antiaggregant other than aspirin in the 5 days prior to implantation
  • •INR\> 3\.5 or INR \<2
  • •Denial of informed consent

Outcomes

Primary Outcomes

Not specified

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