Bleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension

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

Sponsors

Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Source Centre Hospitalier Universitaire de Saint Etienne
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.

Overall Status Recruiting
Start Date 2017-07-05
Completion Date 2022-12-01
Primary Completion Date 2021-12-01
Study Type Observational
Primary Outcome
Measure Time Frame
Number of major bleeding (according to the International Society on Thrombosis and Haemostasis definition) 1 year
Secondary Outcome
Measure Time Frame
Number of clinically relevant bleedings 1 year
Enrollment 203
Condition
Intervention

Intervention Type: Drug

Intervention Name: Oral anticoagulant treatment

Description: The treatment is delivered according to the usual practice.

Arm Group Label: Oral anticoagulant treatment

Eligibility

Sampling Method: Non-Probability Sample

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).

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Laurent Bertoletti, PhD Principal Investigator CHU de Saint-Etienne
Overall Contact

Last Name: Laurent Bertoletti, PhD

Phone: 04.77.82.91.21

Phone Ext.: +33

Email: [email protected]

Location
Facility: Status: Investigator:
CHU Clermont-Ferrand | Clermont-Ferrand, France Not yet recruiting Claire DAUPHIN, MD Principal Investigator Romain TRESORIER, MD Sub-Investigator
CHU de Grenoble | Grenoble, 38100, France Recruiting Christophe Pison, MD Principal Investigator Hélène Bouvaist, MD Sub-Investigator
Hospices Civils de Lyon | Lyon, 69002, France Recruiting Vincent Cottin, MD Principal Investigator Ségolène Turquier, MD Sub-Investigator Clément Deudon, MD Sub-Investigator Julie Traclet, MD Sub-Investigator Kais Ahmad, MD Sub-Investigator
CHU de Saint-Etienne | Saint-Etienne, 42055, France Recruiting Laurent Bertoletti, PhD 04 77 82 91 21 +33 [email protected] Laurent Bertoletti, PhD Principal 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 Sub-Investigator
Location Countries

France

Verification Date

2020-10-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Oral anticoagulant treatment

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

Acronym HEMA-HTP
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov

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