Outcomes of an Anticoagulation Clinic in an University Hospital

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cardiopathy, Chagas Disease, Hemorrhage, Thrombosis

Intervention / Treatment
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* Other: Anticoagulation clinic
* Other: Standard anticoagulation care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anticoagulation clinic<br>Anticoagulation clinic, including all procedures related to a standardized use of coumarins. | Other: Anticoagulation clinic<br>* Patients randomized to this arm will be cared at an anticoagulation clinic, with educational measures and standardized procedures related to the use of coumarins.<br>* Other names: Implementation of a health service;|
| Active Comparator: Standard care<br>Standard use of coumarins, as prescribed by their physicians. | Other: Standard anticoagulation care<br>* 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.<br>* Other names: Implementation of a health service;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in therapeutic range |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemorrhagic events |  | 1 year | 
| Thromboembolic events |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral anticoagulants, Warfarin, Anticoagulation clinic, Thrombosis, Hemorrhage