Evaluation of the Implantation of an Anticoagulation Clinic in the Assistance of Chagas and Non-Chagas Patients at the Hospital of Clinics of the Universidade Federal de Minas Gerais - UFMG

Phase 4

• Conditions: Heart DiseasesChagas DiseaseHemorrhageThrombosis; C03.752.300.900.200; D03.438.150.446.520.914; C14.907.355; C14.280.067.198; C23.550.414

• Registration Number: RBR-88btzp
• Lead Sponsor: niversidade Federal de Minas Gerais

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-10
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Outpatients
Chagas and non-Chagas disease patients
Any indication for chronic treatment with warfarin
Anticoagulation for at least 30 days.

Exclusion Criteria

Refusal to participate in the study
Use of phenprocoumon
Expectation of treatment lower than 1 year
Difficulties to attend medical visits
Participation in any other type of research involving anticoagulation during this study period

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Calculation of the Time of International Normalized Ratio (INR) in therapeutic range. <br>The method proposed by Rosendaal will be applied to calculate the percentage of the time within the therapeutic range for the target INR 2-3 and 2,5-3,5, defined for each clinical condition<br>Time Frame: 1 year<br>

Secondary Outcome Measures

Name	Time	Method
Hemorrhagic events<br>Safety Issue<br>Criteria<br>Minor bleeding (any type of bleeding that did not required hospitalization, specific procedures and/or hemotransfusion) <br>Major bleeding (any type of bleeding that required hospitalization, specific procedures and/or hemotransfusion)<br>Fatal bleeding: bleeding involved directly to patient's death<br>Time Frame: 1 year<br>;Thromboembolic events<br>Safety Issue<br>Criteria:<br>Evidence of thromboembolic event confirmed by appropriate image exam, including deep or superficial venous thrombosis, systemic thrombosis, heart thrombus, isquemic stroke<br>Time Frame: 1 year<br>