Outcomes of an Anticoagulation Clinic in an University Hospital

October 24, 2011 updated by: Antonio Luiz Pinho Ribeiro, Federal University of Minas Gerais

Evaluation of Impact of the Implantation of an Anticoagulation Clinic in an University Hospital in Brazil

A clinical trial designed to compare the oral anticoagulation control obtained by an anticoagulation clinic and the usual medical care in Chagas and Non-Chagas disease patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Randomized, Crossover, Clinical Trial performed to compare the results of oral anticoagulation for Chagas and non-Chagas disease patients treated at an anticoagulation clinic and by the usual clinical practice. The primary endpoint was the time that the International Normalized Ratio (INR) was in the therapeutic range and the secondary endpoints were thromboembolic/haemorragic events.

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-100
        • Federal University of Minas Gerais

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 other prospective clinical study involving anticoagulation care during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anticoagulation clinic
Anticoagulation clinic, including all procedures related to a standardized use of coumarins.
Other: Anticoagulation clinic
Patients randomized to this arm will be cared at an anticoagulation clinic, with educational measures and standardized procedures related to the use of coumarins.
Other Names:
  • Implementation of a health service
Active Comparator: Standard care
Standard use of coumarins, as prescribed by their physicians.
Other: Standard anticoagulation care
Patients randomized to this arm will be cared by their physician, with standard care. No standardized protocol of the use of coumarins will be established.
Other Names:
  • Implementation of a health service

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time in therapeutic range
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Hemorrhagic events
Time Frame: 1 year
1 year
Thromboembolic events
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Investigators

  • Study Chair: Antonio L Ribeiro, MD, PhD, Federal University of Minas Gerais
  • Principal Investigator: Manoel Otávio C Rocha, MD, PhD, Federal University of Minas Gerais
  • Principal Investigator: Maria Auxiliadora P Martins, Pharmacist, Federal University of Minas Gerais
  • Principal Investigator: Cibele C César, MD, PhD, Federal University of Minas Gerais
  • Principal Investigator: Daniel D Ribeiro, Physician, Federal University of Minas Gerais
  • Principal Investigator: Vandack Nobre, MD, PhD, Federal University of Minas Gerais

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

November 1, 2009

First Submitted That Met QC Criteria

November 1, 2009

First Posted (Estimate)

November 1, 2009

Study Record Updates

Last Update Posted (Estimate)

October 25, 2011

Last Update Submitted That Met QC Criteria

October 24, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COEP376/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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