NCT01955811

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Blood Platelet Transfusion
• Blood Clotting

Interventions

Type	Name	Description
DRUG	Administration of platelet concentrate and taking blood samples	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.

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-10-08
• Last updated: 2016-03-23

Locations

5 sites across 2 countries: Austria, Denmark