Bleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension (HEMA-HTP)

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Oral anticoagulant treatment

Study type: Observational

Funder types: Other

Identifiers

NCT02800941

1608037

2016-001608-41 (EudraCT Number)

Details and patient eligibility

About

Pulmonary hypertension (PHT) patients often receive long term oral anticoagulants. If the indication is strong, in the secondary chronic thrombo-embolism pulmonary hypertension (CTE-PHT) prevention, the frequent prescription (50 to 90% of patients) contrasts with their low level of proof in the PHT. Last but not least, anticoagulants are known to be the principal cause of iatrogenic hospitalization (major bleeding).

In this study, patients are all followed during one year, to determine the annual frequency of major bleedings (according to the International Society on Thrombosis and Haemostasis (ISTH) international definition). Each event notified is validated by an independent committee for clinical events.

Full description

Pulmonary hypertension (PHT) patients often receive long term oral anticoagulants. If the indication is strong, in the secondary chronic thrombo-embolism pulmonary hypertension (CTE-PHT) prevention, the frequent prescription (50 to 90% of patients) contrasts with their low level of proof in the PHT. Last but not least, anticoagulants are known to be the principal cause of iatrogenic hospitalization (bleeding).

The only one study scaling the tolerance of anticoagulants for this population found major hemorrhagic levels discording with the clinical practice : really high for connectives associated to pulmonary arterial hypertension (PAHT), and lower in "simple" pulmonary embolism in CTE-PHT. These discoveries could belong to methodological failures of this study: a retrospective, monocentric one, without adjudication of events by an independent committee. Furthermore, there were no information about the existence of a validated indication for anticoagulant treatments.

Patients are all followed during one year, to determine the annual frequency of major bleedings (according to the International Society on Thrombosis and Haemostasis (ISTH) international definition). Each event notified is validated by an independent committee for clinical events.

Enrollment: 203 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient insured or entitled to a social security scheme;
• Patient with confirmed pulmonary hypertension;
• Pulmonary hypertension among the following etiological diagnosis: idiopathic PAH, PAH associated with appetite suppressants, PAH associated with connective, or Chronic Thrombo-embolism Pulmonary Hypertension;
• Patients receiving oral anticoagulants.

Exclusion criteria

• Impossible following;
• Bleeding at baseline;
• Life expectancy of less than 3 months;
• Pulmonary hypertension in Group 2, Group 3 (in the absence of associated pulmonary embolism) and Group 5 (in the absence of associated pulmonary embolism).

Trial design

203 participants in 1 patient group

Oral anticoagulant treatment

Description:

Patients with pulmonary hypertension are treated with oral anticoagulants according to the usual practice. Patients have follow-up at 3, 6 and 12 months.

Treatment:

Drug: Oral anticoagulant treatment