Clinical trial NCT02800941: Bleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension
Official title: Bleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension : HEMA-HTP Multicentric Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary Arterial hypertension
Oral anticoagulants
Major bleedings
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort of pulmonary hypertension patients receiving oral anticoagulant treatment.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of major bleeding (according to the International Society on Thrombosis and Haemostasis definition)
timeFrame: 1 year
Secondary outcomes:
measure: Number of clinically relevant bleedings
timeFrame: 1 year
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Saint-Etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Laurent Bertoletti, PhD
role: PRINCIPAL_INVESTIGATOR
References: