Study to Reveal if Fibrinogen Treatment Effects Blood Clotting Better Than a Platelet Transfusion

Study Overview
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Brief Summary
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Patients with need of platelet transfusion for any reason will participate in this study. Directly before the start of infusion and one hour after the end of platelet transfusion blood samples will be drawn and treated with different concentrations of Fibrinogen (a blood clotting factor) in-vitro. Blood samples with and without Fibrinogen/platelet transfusion will be compared. The study hypothesis is that treatment with Fibrinogen results in a better stabilisation of blood coagulation.

Detailed Description
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In total 300 patients with the need of platelet transfusion for whatever reason will be included when meeting the inclusion- and exclusion criteria. For all patients three visits are planned, where blood samples will be taken. The first blood samples will be taken directly before the start of platelet transfusion, the second 1 hour after the end of the platelet transfusion and the third after 24 hours. Untreated citrate and EDTA blood samples from Visit 1 will be serving as baseline for the coagulation testing. Further citrate blood samples from the first visit will be spiked with different concentrations of fibrinogen in vitro. Untreated citrate and EDTA blood samples will be taken 1 hour and 24 hours after platelet transfusion for comparison. Further citrate blood samples will be spiked with different concentrations of fibrinogen in vitro again 1 hour after platelet transfusion. In addition, randomly chosen samples will be analyzed using confocal microscopy. Routine coagulation analysis include activated partial thromboplastin time (aPTT), prothrombin time(PT), fibrinogen, blood coagulation factor thirteen (FXIII), thromboelastometry (ExTEM & FibTEM) before and after platelet transfusion.

Official Title
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Bicentric Clinical Trial With in Vitro Experiments to Assess the Effect of Fibrinogen (FGTW) on Coagulation in Thrombocytopenia

Conditions
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Blood Platelet Transfusion, Blood Clotting

Intervention / Treatment
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* Drug: Administration of platelet concentrate and taking blood samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient with the clinical need for platelet transfusion age: 18 - 85 years Exclusion Criteria: pregnant or nursing women patients who disagree to participate in 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 in the ability to interpret data from the study any serious medical condition, laboratory abnormalities, or psychiatric illness, that would prevent the subject from signing the informed consent form

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Platelet concentrate transfusion and Human Fibrinogen<br>Blood samples will be collected directly before the start of transfusion and 1 hour after the end of transfusion. These samples will be spiked with Human Fibrinogen and clotting tests will be performed. After 24 h after end of transfusion a clotting test will be performed again. | Drug: Administration of platelet concentrate and taking blood samples<br>* Patient with the need of a platelet transfusion, will have 4 intervention points. 1. directly before the start of the transfusion a blood sample will be drawn. 2. Patient receives the platelet transfusion. 3. One hour after the end of transfusion a second blood sample will be drawn. 4. 24 h after the end of the platelet transfusion a further bloos sample will be collected. The first two samples will be (beside blood cell counts) spiked in-vitro with different amounts of Human fibrinogen and blood clotting tests will be performed. The same with the 3. blood sample, but without spiking steps.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 1 hour after platelet transfusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the difference in the response profile of Blood cell count (EDTA blood sample) |  | before and 1 hour after platelet transfusion | 
| Standard coagulation tests as aPTT, PT, fibrinogen and FXIII |  | before and 1 hour after platelet transfusion | 
| Further bleeding management system(ROTEM®)parameters | maximum clot firmness(MCF) clotting time(CT) clot formation time (CFT) lysis index 30 minutes after CT (L30) | before and one hour after platelet transfusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet transfusion, Fibrinogen, blood coagulation, Thrombocytopenia, in-vitro experiments, FGTW, Fit2012, factor I, Fibrin