Fibrinogen and platelets in patients with acute myeloid leukaemia and thrombocytopenia

Phase 1

• Conditions: Bleeding i patients with acute myeloid leukemia; MedDRA version: 20.0 Level: LLT Classification code 10005103 Term: Bleeding System Organ Class: 100000004866; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2019-004295-18-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-19
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1.Patients treated for non-promyelocyte AML with intensive chemotherapy at the Department of Haematology, Aarhus University Hospital.
2.Able to give written informed consent
3.Above 18 years old
4.Fertile women must have a negative pregnancy test and agree to use safe anti-conception(hormonal anti-conception or intrauterine device) for 30 days after receiving the study treatment.

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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.Known inherited bleeding disorder
2.Known serious thrombophilia(antithrombin deficiency, protein C or S deficiency, homozygous factor V Leiden)
3.Thromboembolic disease within the past 3 months
4.Known allergy to Riastap

Study & Design

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