Outcomes of an Anticoagulation Clinic in an University Hospital

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01006486

Enrollment

280

Registered

2009-11-02

Start date

2009-11-30

Completion date

2011-08-31

Last updated

2011-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopathy, Chagas Disease, Hemorrhage, Thrombosis

Keywords

Oral anticoagulants, Warfarin, Anticoagulation clinic, Thrombosis, Hemorrhage

Brief summary

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

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.

Interventions

OTHERAnticoagulation 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.

OTHERStandard 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Time in therapeutic range	1 year

Secondary

Measure	Time frame
Hemorrhagic events	1 year
Thromboembolic events	1 year

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026