Investigation of the effect of fibrinogen on blood clotting in patients with lack of platelets before and after a platelet-transfusion

Bicentric clinical trial with in vitro experiments to assess the effect of Fibrinogen (FGTW) on Coagulation in Thrombocytopenia - Fibrinogen in Thrombocytopenia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004087-22-AT

Enrollment

300

Registered

2012-09-26

Start date

2012-12-19

Completion date

Unknown

Last updated

2015-08-04

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

Conditions

Thrombocytopenia MedDRA version: 14.1 Level: HLT Classification code 10043555 Term: Thrombocytopenias System Organ Class: 100000004851

Interventions

Product Name: Thrombocyte Concentrate Pharmaceutical Form: Solution for infusion Product Name: Pool-Thrombocyte Concentrate Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Patient with the clinical need for platelet transfusion ? Age 18-85 years 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 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: ? Pregnant and nursing women ? Patients who disagree to participate on the study for emergency patients: patients with known refusal of a participation in this clinical trial ? Active participation in a clinical trial ? Any condition, including the presence of laboratory abnormalities, which would place confound the ability to interpret data from the study ? Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to assess the difference in A30 (ExTEM®) between blood samples after in vitro spiking and compared to those blood samples obtained from the same patients after platelet-transfusion. ;Secondary Objective: Assessment of the difference in the response profile of the following parameters: ? Blood cell count (EDTA blood sample) ? Standard coagulation tests as aPTT, PT, fibrinogen and FXIII ? Further ROTEM® parameters ? confocal microscopy ? Other biological paramaters (thrombingeneration, d-dimers, etc.) ;Primary end point(s): The difference in the A30 (ExTEM®) between samples spiked with fibrinogen before and one hour after platelets transfusion.;Timepoint(s) of evaluation of this end point: Visit 1: Timepoint 0 hours versus Visit 2: Timepoint 1 hour	—

Measure

Time frame

Main Objective: The primary objective is to assess the difference in A30 (ExTEM®) between blood samples after in vitro spiking and compared to those blood samples obtained from the same patients after platelet-transfusion. ;Secondary Objective: Assessment of the difference in the response profile of the following parameters: ? Blood cell count (EDTA blood sample) ? Standard coagulation tests as aPTT, PT, fibrinogen and FXIII ? Further ROTEM® parameters ? confocal microscopy ? Other biological paramaters (thrombingeneration, d-dimers, etc.) ;Primary end point(s): The difference in the A30 (ExTEM®) between samples spiked with fibrinogen before and one hour after platelets transfusion.;Timepoint(s) of evaluation of this end point: Visit 1: Timepoint 0 hours versus Visit 2: Timepoint 1 hour

—

Secondary

Measure	Time frame
Secondary end point(s): ? Difference in the Blood cell count (EDTA blood sample) between Visit 1, Visit 2 and Visit 3 ? Difference in the standard coagulation tests as aPTT, PT, fibrinogen and FXIII of fibrinogen-spiked blood samples before and after-transfusion ? Difference in further ROTEM® parameters of fibrinogen-spiked blood samples before and after-transfusion ? Difference in other biological paramaters (thrombingeneration, d-dimers, etc.) of fibrinogen-spiked blood samples before and after-transfusion ? Difference in confocal microscopy images of fibrinogen-spiked blood samples before and after-transfusion ;Timepoint(s) of evaluation of this end point: Visit 1: Timepoint 0 hours versus Visit 2: Timepoint 1 hour Visit 3: Timepoint 24 hours	—

Measure

Time frame

Secondary end point(s): ? Difference in the Blood cell count (EDTA blood sample) between Visit 1, Visit 2 and Visit 3 ? Difference in the standard coagulation tests as aPTT, PT, fibrinogen and FXIII of fibrinogen-spiked blood samples before and after-transfusion ? Difference in further ROTEM® parameters of fibrinogen-spiked blood samples before and after-transfusion ? Difference in other biological paramaters (thrombingeneration, d-dimers, etc.) of fibrinogen-spiked blood samples before and after-transfusion ? Difference in confocal microscopy images of fibrinogen-spiked blood samples before and after-transfusion ;Timepoint(s) of evaluation of this end point: Visit 1: Timepoint 0 hours versus Visit 2: Timepoint 1 hour Visit 3: Timepoint 24 hours

—

Countries

Austria, Denmark

Contacts

Public ContactProjektmanagement

Medizinische Universität Innsbruck / Univ.-Klinik für Allgem. und Chirurgische Intensivmedizin

mirjam.bachler@i-med.ac.at+4351250480451

Outcome results

None listed

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