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

• ClinicalTrials.gov Identifier: NCT02800941
• Recruitment Status: Recruiting
• First Posted: June 15, 2016
• Last Update Posted: October 20, 2020
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Saint Etienne

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
Pulmonary Arterial Hypertension	Drug: Oral anticoagulant treatment

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.

Study Design

• Study Type: Observational
• Estimated 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: July 5, 2017
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: December 2022

Groups and Cohorts

Group/Cohort	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 :

1. Number of major bleeding (according to the International Society on Thrombosis and Haemostasis definition) [ Time Frame: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Cohort of pulmonary hypertension patients receiving oral anticoagulant treatment.

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).

Contacts and Locations

Contacts

Contact: Laurent Bertoletti, PhD; 04.77.82.91.21 ext +33; laurent.bertoletti@chu-st-etienne.fr

Contact: Carine Labruyere, CRA; 04 77 12 04 69 ext +33; carine.labruyere@chu-st-etienne.fr

Locations

France

CHU Clermont-Ferrand; Not yet recruiting

Clermont-Ferrand, France

Principal Investigator: Claire DAUPHIN, MD

Sub-Investigator: Romain TRESORIER, MD

CHU de Grenoble; Recruiting

Grenoble, France, 38100

Principal Investigator: Christophe Pison, MD

Sub-Investigator: Hélène Bouvaist, MD

Hospices Civils de Lyon; Recruiting

Lyon, France, 69002

Principal Investigator: Vincent Cottin, MD

Sub-Investigator: Ségolène Turquier, MD

Sub-Investigator: Clément Deudon, MD

Sub-Investigator: Julie Traclet, MD

Sub-Investigator: Kais Ahmad, MD

CHU de Saint-Etienne; Recruiting

Saint-Etienne, France, 42055

Contact: Laurent Bertoletti, PhD 04 77 82 91 21 ext +33 laurent.bertoletti@chu-st-etienne.fr

Principal Investigator: Laurent Bertoletti, PhD

Sub-Investigator: Elodie De Magalhaes, MD

Sub-Investigator: Sandrine Accassat, MD

Sub-Investigator: Cécile Duvillard, MD

Sub-Investigator: Judith Catella, MD

Sub-Investigator: Jean-Baptiste Gaultier, MD

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

• Principal Investigator: Laurent Bertoletti, PhD; CHU de Saint-Etienne

More Information

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT02800941
• Other Study ID Numbers: 1608037; 2016-001608-41 ( EudraCT Number )
• First Posted: June 15, 2016
• Last Update Posted: October 20, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:

Pulmonary Arterial hypertension; Oral anticoagulants; Major bleedings

Additional relevant MeSH terms:

Hypertension, Pulmonary; Hypertension; Hemorrhage; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Lung Diseases; Respiratory Tract Diseases; Warfarin; Anticoagulants; Acenocoumarol; Fluindione