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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet concentrate transfusion and Human Fibrinogen | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of platelet concentrate and taking blood samples | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
pregnant or nursing women
patients who disagree to participate in the study
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
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| Name | Affiliation | Role |
|---|---|---|
| Dietmar Fries, Univ-Prof.Dr | General and Surgical Intensive Care Medicine, Medical University Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Institution for Blood Transfution and Immunology | Innsbruck | Tyrol | 6020 | Austria | ||
| Department for Anesthesia and Intensive Care Medicine |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 6, 2021 | |
| Reset | Oct 1, 2021 |
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|
| 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 |
| Innsbruck |
| Tyrol |
| 6020 |
| Austria |
| General and Surgical Intensive Care Medicine | Innsbruck | Tyrol | 6020 | Austria |
| Faculty of Health Sciences, Centre for Haemophilia and Thrombosis, Aarhus University Hospital | Aarhus | Skejby | 8200 | Denmark |
| Faculty of Health Sciences, Department for Anaesthesia and Critical Care Medicine | Aarhus | Skejby | 8200 | Denmark |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 6, 2021 | Oct 1, 2021 |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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