Skip to main content
OpenTrials
Completed

NCT Number: NCT01955811

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Blood Platelet Transfusion Blood Clotting Blood Platelet Disorders Cardiovascular Diseases Cytopenia Embolism and Thrombosis Hematologic Diseases Hemic and Lymphatic Diseases Thrombocytopenia Thrombosis Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Central Institution for Blood Transfution and Immunology, Innsbruck, Tyrol, Austria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Assessment of the difference in the response profile of Blood cell count (EDTA blood sample)

    Time frame: before and 1 hour after platelet transfusion

  2. Standard coagulation tests as aPTT, PT, fibrinogen and FXIII

    Time frame: before and 1 hour after platelet transfusion

  3. 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)

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

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

Acronym: FiT2012

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 8, 2013
Registry last updated
Mar 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.