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

March 22, 2016 updated by: Dietmar Fries, M.D., Medical University Innsbruck

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Central Institution for Blood Transfution and Immunology
      • Innsbruck, Tirol, Austria, 6020
        • Department for Anesthesia and Intensive Care Medicine
      • Innsbruck, Tirol, Austria, 6020
        • General and Surgical Intensive Care Medicine
  • Denmark
    • Skejby
      • Aarhus, Skejby, Denmark, 8200
        • Faculty of Health Sciences, Centre for Haemophilia and Thrombosis, Aarhus University Hospital
      • Aarhus, Skejby, Denmark, 8200
        • Faculty of Health Sciences, Department for Anaesthesia and Critical Care Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 1 hour 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)
Time Frame: before and 1 hour after platelet transfusion
before and 1 hour after platelet transfusion
Standard coagulation tests as aPTT, PT, fibrinogen and FXIII
Time Frame: before and 1 hour after platelet transfusion
before and 1 hour after platelet transfusion
Further bleeding management system(ROTEM®)parameters
Time Frame: before and one hour after platelet transfusion
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Investigators

  • Principal Investigator: Dietmar Fries, Univ-Prof.Dr, General and Surgical Intensive Care Medicine, Medical University Innsbruck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

September 2, 2013

First Submitted That Met QC Criteria

September 27, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Estimate)

March 23, 2016

Last Update Submitted That Met QC Criteria

March 22, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FiT2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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