Pacemaker implant for anticoagulated patients
Conditions
Interventions
Trade Name: Amchafibrin
Product Name: TRANEXAMIC ACID
Product Code: 53939
Pharmaceutical Form: Concentrate for concentrate for solution for infusion
INN or Proposed INN: TRANEXAMIC ACID
Other descript
Sponsors
Rafael Blancas-Gómez Casero
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Prolongation of hospital stay 2. Infections: infection of the surgical wound, of the pacemaker bag, bacteraemia, endocarditis. 3. Thrombotic complications;Timepoint(s) of evaluation of this end point: At 24 hours and 7, 15 and 30 days and 6 months after pacemaker implantation | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of hemorrhage and / or hematoma in anticoagulated patients with acenocoumarol after pacemaker implantation and the effect of tranexamic acid (TXA) to reduce these events.;Secondary Objective: 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;Primary end point(s): 1. Bleeding: according to previous literature we will differentiate between minor or major bleeding A. Minor bleeding: • Pocket hematoma that consists of the appearance of an elevated, painful mass with ecchymosis around the generator. Therefore, we must reflect both the maximum and minimum diameters and the height in millimeters. • Decrease in hemoglobin <2 g / dL after the procedure and without requiring transfusion of blood products. • Need for suspension of anticoagulant drugs. B. Major hemorrhage: defined by the International Society of Thrombosis and Hemostasis (8) • Bleeding related to a pacemaker implant with a decrease in hemoglobin = 2 g / dL after the procedure. • Hemorrhage that requires transfusion of blood products. • Need to evacuate pocket hematoma or surgical revision. • Appearance of hemopericardium. • Appearance of hemothorax. • Bleeding with data of organ hypoperfusion (renal failure, lactic acidosis, neurological impairment, liver damage), not attributable to other causes.;Timepoint(s) of evaluation of this end point: At 7, 15, 30 days and 6 months in the implant center. | — |
Countries
Spain
Contacts
Public ContactRafael Blancas-Gómez Casero
Rafael Blancas-Gómez Casero
Outcome results
None listed