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Perioperative Eltrombopag in Patients With Inherited Thrombocytopenia

NCT03638817 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-08-27

No results posted yet for this study

Summary

The objective of the study is to estimate the response to eltrombopag based on platelet count increase above a safety level of 80 G/L and lack of requirement for pre-, per- and post-operative administration of platelet concentrates (PC) for performing elective invasive acts at mild or high bleeding risk,in selected patients with inherited thrombocytopenia (IT).

Conditions

Interventions

DRUG

Eltrombopag

Eltrombopag will be prescribed at doses recommended in primary immune thrombocytopenia (50, 25 or 75 mg), starting 4 weeks before the procedure and stopped 2 days before. PC will be administrated prophylactically if the platelet count is \< 80 G/L or per/post-operatively in case of bleeding of undetermined cause. Antifibrinolytics will be authorized and low molecular weight heparin prescribed if indicated for the prophylaxis of postoperative venous thrombosis according to the standard dose and duration, , irrespective of the platelet count

Sponsors & Collaborators

  • French network for inherited hemorragic diseases

    collaborator UNKNOWN

  • National Reference Centre for Platelet Pathologies

    collaborator UNKNOWN

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Pierre SIE, Prof. · University Hospital, Toulouse

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-02
Primary Completion
2023-06-27
Completion
2023-06-27

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03638817 on ClinicalTrials.gov