Study to Reveal if Fibrinogen Treatment Effects Blood Clotting Better Than a Platelet Transfusion (FiT2012)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Medical University Innsbruck
Sponsor:
Information provided by (Responsible Party):
Dietmar Fries, M.D., Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT01955811
First received: September 2, 2013
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Blood Platelet Transfusion
Blood Clotting
Drug: Administration of platelet concentrate and taking blood samples
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Bicentric Clinical Trial With in Vitro Experiments to Assess the Effect of Fibrinogen (FGTW) on Coagulation in Thrombocytopenia

Resource links provided by NLM:


Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:
  • 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 [ Time Frame: 1 hour after platelet transfusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of the difference in the response profile of Blood cell count (EDTA blood sample) [ Time Frame: before and 1 hour after platelet transfusion ] [ Designated as safety issue: No ]
  • Standard coagulation tests as aPTT, PT, fibrinogen and FXIII [ Time Frame: before and 1 hour after platelet transfusion ] [ Designated as safety issue: No ]
  • Further bleeding management system(ROTEM®)parameters [ Time Frame: before and one hour after platelet transfusion ] [ Designated as safety issue: No ]
    maximum clot firmness(MCF) clotting time(CT) clot formation time (CFT) lysis index 30 minutes after CT (L30)


Estimated Enrollment: 300
Study Start Date: December 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01955811

Contacts
Contact: Bettina Schenk, MSc +43-512-504-80604 bettina.schenk@i-med.ac.at
Contact: Mirjam Bachler, Mag +43-512-504-80451 mirjam.bachler@i-med.ac.at

Locations
Austria
General and Surgical Intensive Care Medicine Recruiting
Innsbruck, Tirol, Austria, 6020
Sub-Investigator: Barbara Friesenecker, Dr.         
Sub-Investigator: Stefan Schmid, Dr.         
Sub-Investigator: Gottfried Gruber, Dr.         
Sub-Investigator: Gabriele Schögler, Dr.         
Department for Anesthesia and Intensive Care Medicine Recruiting
Innsbruck, Tirol, Austria, 6020
Sub-Investigator: Petra Innerhofer, Dr.         
Sub-Investigator: Axel Kleinsasser, Dr.         
Sub-Investigator: Elgar Oswald, Dr.         
Sub-Investigator: Wolfgang Koller, Dr.         
Central Institution for Blood Transfution and Immunology Recruiting
Innsbruck, Tirol, Austria, 6020
Sub-Investigator: Harald Schennach, Prof. Dr.         
Denmark
Faculty of Health Sciences, Centre for Haemophilia and Thrombosis, Aarhus University Hospital Recruiting
Aarhus, Skejby, Denmark, 8200
Sub-Investigator: Hans Christian Fenger Eriksen, Dr., PHD         
Faculty of Health Sciences, Department for Anaesthesia and Critical Care Medicine Recruiting
Aarhus, Skejby, Denmark, 8200
Sub-Investigator: Ole Halfdan Larsen, Dr.,PHD         
Sponsors and Collaborators
Medical University Innsbruck
Investigators
Principal Investigator: Dietmar Fries, Univ-Prof.Dr General and Surgical Intensive Care Medicine, Medical University Innsbruck
  More Information

No publications provided

Responsible Party: Dietmar Fries, M.D., Ao. Univ.-Prof. Dr., Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT01955811     History of Changes
Other Study ID Numbers: FiT2012
Study First Received: September 2, 2013
Last Updated: September 27, 2013
Health Authority: Austria : Federal Ministry for Labour, Health, and Social Affairs

Keywords provided by Medical University Innsbruck:
platelet transfusion
Fibrinogen
blood coagulation
Thrombocytopenia
in-vitro experiments
FGTW
Fit2012
factor I
Fibrin

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014