Fibrinogen and platelets in patients with acute myeloid leukaemia and thrombocytopenia

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004295-18-DK

Enrollment

Registered

2019-11-19

Start date

2019-12-13

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding i patients with acute myeloid leukemia MedDRA version: 20.0 Level: LLT Classification code 10005103 Term: Bleeding System Organ Class: 100000004866

Interventions

Trade Name: Riastap Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Riastap CAS Number: 9001-32-5 Other

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this study is to investigate the efficacy of fibrinogen concentrate as bleeding prophylaxis in patients with thrombocytopenia suffering from AML Primary objectives The specific objectives are to investigate: a) Whether administration of fibrinogen concentrate beyond platelet transfusions increases clot initiation and clot strength. b) If there is a difference in the fibrin network structure between: 1. Healthy individuals with in vitro induced thrombocytopenia and leukaemia patients with thrombocytopenia undergoing chemotherapy. 2. Baseline, after platelet transfusion and after administration of fibrinogen concentrate in leukaemia patients with thrombocytopenia undergoing chemotherapy. ;Secondary Objective: not applicable;Primary end point(s): Improvement in clot initiation (ROTEM, low tissue factor assay) determined as shorter clotting time after in vivo administration of fibrinogen concentrate subsequent to platelet transfusion.; Timepoint(s) of evaluation of this end point: The primary end point will be evaluated after the collection of all data. No interim analyses will be performed.	—

Measure

Time frame

Main Objective: The purpose of this study is to investigate the efficacy of fibrinogen concentrate as bleeding prophylaxis in patients with thrombocytopenia suffering from AML Primary objectives The specific objectives are to investigate: a) Whether administration of fibrinogen concentrate beyond platelet transfusions increases clot initiation and clot strength. b) If there is a difference in the fibrin network structure between: 1. Healthy individuals with in vitro induced thrombocytopenia and leukaemia patients with thrombocytopenia undergoing chemotherapy. 2. Baseline, after platelet transfusion and after administration of fibrinogen concentrate in leukaemia patients with thrombocytopenia undergoing chemotherapy. ;Secondary Objective: not applicable;Primary end point(s): Improvement in clot initiation (ROTEM, low tissue factor assay) determined as shorter clotting time after in vivo administration of fibrinogen concentrate subsequent to platelet transfusion.; Timepoint(s) of evaluation of this end point: The primary end point will be evaluated after the collection of all data. No interim analyses will be performed.

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Secondary

Measure	Time frame
Secondary end point(s): • 30 days mortality • Thromboembolic events ; Timepoint(s) of evaluation of this end point: The Secondary end points will be evaluated after the collection of all data. No interim analyses will be performed.	—

Countries

Denmark

Contacts

Public ContactDepartment of Biochemistry

Aarhus University Hospital

biokemi@auh.rm.dk+4540465739

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026