se of fibrinogen in the treatment of bleeding in thrombopenic patients after intensive chemotherapy refractory to platelet transfusio

Phase 1

• Conditions: - Major patient; - Patient with malignant hemopathy requiring intensive chemotherapy, autologous or allogeneic hematopoietic stem cell transplantation; - Grade = 1 hemorrhagic symptom according to WHO - WHO classification; - Body weight between 38 and 78 kg; - Patient presenting with a platelet refractory state defined according to the Corrected Count Increment (CCI); - Patient affiliated to a social security scheme; MedDRA version: 21.1Level: LLTClassification code 10066481Term: Hematological malignancySystem Organ Class: 100000004864; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2021-000990-10-FR
• Lead Sponsor: Institut de Cancérologie Lucien Neuwirth

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-09
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

- Major patient;
- Patient with malignant hemopathy requiring intensive chemotherapy, autologous or allogeneic hematopoietic stem cell transplantation;
- Grade = 1 hemorrhagic symptom according to WHO - WHO classification;
- Body weight between 38 and 78 kg;
- Patient presenting with a platelet refractory state defined according to the Corrected Count Increment (CCI);
- Patient affiliated to a social security scheme
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

- Patient who expressed his opposition to participating in the study;
- Pregnant or breastfeeding woman;
- Legal incapacity or limited legal capacity. Medical or psychological conditions that do not allow the subject to understand the study and sign the consent (art. L.1121-6, L.1121-7, L.1211-8, L.1211-9);
- Patient with non-malignant hematological involvement;
- Patient with a high plasma fibrinogen concentration (> 5g / L);
- Patient allergic to fibrinogen;
- Patient with disseminated intravascular coagulopathy;
- Indication for the use of anti-thrombotic treatment (anti-platelet, anticoagulant).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified