HEMA-HTP: Bleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Recruiting

CT.gov ID

NCT02800941

Collaborator

(none)

203

Enrollment

Locations

76.9

Anticipated Duration (Months)

50.8

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension	Drug: Oral anticoagulant treatment

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

203 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Bleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension : HEMA-HTP Multicentric Study.

Actual Study Start Date :

Jul 5, 2017

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Oral anticoagulant treatment Patients with pulmonary hypertension are treated with oral anticoagulants according to the usual practice. Patients have follow-up at 3, 6 and 12 months.	Drug: Oral anticoagulant treatment The treatment is delivered according to the usual practice. Other Names: warfarin (Coumadine®) fluindione (Préviscan®) acenocoumarol (Sintrom®)

Arm

Intervention/Treatment

Oral anticoagulant treatment

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

Drug: Oral anticoagulant treatment

The treatment is delivered according to the usual practice.

Other Names:

warfarin (Coumadine®)

fluindione (Préviscan®)

acenocoumarol (Sintrom®)

Outcome Measures

Primary Outcome Measures

Number of major bleeding (according to the International Society on Thrombosis and Haemostasis definition) [1 year]
Major bleedings (according to the International Society on Thrombosis and Haemostasis definition) will be notified during one year under oral anticoagulant treatment.

Secondary Outcome Measures

Number of clinically relevant bleedings [1 year]
Clinically relevant bleedings (major and non major ones) will be notified during one year under oral anticoagulant treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU Clermont-Ferrand	Clermont-Ferrand	France
2	CHU de Grenoble	Grenoble	France	38100
3	Hospices Civils de Lyon	Lyon	France	69002
4	CHU de Saint-Etienne	Saint-Etienne	France	42055