Bleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension

Pulmonary Arterial Hypertension Clinical Trial

— HEMA-HTP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02800941
• Other study ID #: 1608037
• Secondary ID: 2016-001608-41
• Status: Completed
• Start date: July 5, 2017
• Est. completion date: September 5, 2023

Study information

• Verified date: June 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: September 5, 2023
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hemorrhage
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Oral anticoagulant treatment
The treatment is delivered according to the usual practice.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	CHU de Grenoble	Grenoble
France	Hospices Civils de Lyon	Lyon
France	CHU de Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of major bleeding (according to the International Society on Thrombosis and Haemostasis definition)	Major bleedings (according to the International Society on Thrombosis and Haemostasis definition) will be notified during one year under oral anticoagulant treatment.	1 year
Secondary	Number of clinically relevant bleedings	Clinically relevant bleedings (major and non major ones) will be notified during one year under oral anticoagulant treatment.	1 year