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

NCT ID: NCT01955811

Last Updated: 2016-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-08-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Platelet concentrate transfusion and Human Fibrinogen

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.

Group Type: OTHER

Administration of platelet concentrate and taking blood samples

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: lead

Responsible Party

Dietmar Fries, M.D.

Ao. Univ.-Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dietmar Fries, Univ-Prof.Dr

Role: PRINCIPAL_INVESTIGATOR

General and Surgical Intensive Care Medicine, Medical University Innsbruck

Locations

Central Institution for Blood Transfution and Immunology

Innsbruck, Tyrol, Austria

Department for Anesthesia and Intensive Care Medicine

Innsbruck, Tyrol, Austria

General and Surgical Intensive Care Medicine

Innsbruck, Tyrol, Austria

Faculty of Health Sciences, Centre for Haemophilia and Thrombosis, Aarhus University Hospital

Aarhus, Skejby, Denmark

Faculty of Health Sciences, Department for Anaesthesia and Critical Care Medicine

Aarhus, Skejby, Denmark

Countries

Austria; Denmark

Other Identifiers

FiT2012

Identifier Type: -

Identifier Source: org_study_id