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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 203

Contacts and Locations

• Study Contact: Name: Laurent Bertoletti, PhD; Phone Number: +33 04.77.82.91.21; Email: laurent.bertoletti@chu-st-etienne.fr
• Study Contact Backup: Name: Carine Labruyere, CRA; Phone Number: +33 04 77 12 04 69; Email: carine.labruyere@chu-st-etienne.fr

Study Locations

• France
  • Clermont-Ferrand, France
    • Recruiting
    • CHU Clermont-Ferrand
    • Principal Investigator: Claire DAUPHIN, MD
    • Sub-Investigator: Romain TRESORIER, MD
  • Grenoble, France, 38100
    • Recruiting
    • CHU de Grenoble
    • Sub-Investigator: Hélène BOUVAIST, MD
    • Principal Investigator: Christophe Pison, MD
  • Lyon, France, 69002
    • Recruiting
    • Hospices Civils de Lyon
    • Sub-Investigator: Clément DEUDON, MD
    • Sub-Investigator: Julie TRACLET, MD
    • Sub-Investigator: Ségolène Turquier, MD
    • Sub-Investigator: Kais Ahmad, MD
  • Saint-Etienne, France, 42055
    • Recruiting
    • CHU de Saint-Etienne
    • Sub-Investigator: Jean-Baptiste GAULTIER, MD
    • Contact: Laurent Bertoletti, PhD; Phone Number: +33 04 77 82 91 21; Email: laurent.bertoletti@chu-st-etienne.fr
    • Principal Investigator: Laurent Bertoletti, PhD
    • Sub-Investigator: Elodie DE MAGALHAES, MD
    • Sub-Investigator: Judith Catella, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cohort of pulmonary hypertension patients receiving oral anticoagulant treatment.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Laurent Bertoletti, PhD, CHU de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 5, 2017
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: June 10, 2016
• First Submitted That Met QC Criteria: June 10, 2016
• First Posted (ESTIMATE): June 15, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Oral anticoagulants; Pulmonary Arterial hypertension; Major bleedings
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hemorrhage; Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Warfarin; Anticoagulants; Acenocoumarol; Fluindione
• Other Study ID Numbers: 1608037; 2016-001608-41 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No