Clinical trial NCT01955811: Study to Reveal if Fibrinogen Treatment Effects Blood Clotting Better Than a Platelet Transfusion
Official title: Bicentric Clinical Trial With in Vitro Experiments to Assess the Effect of Fibrinogen (FGTW) on Coagulation in Thrombocytopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Platelet Transfusion
Blood Clotting
Keywords: platelet transfusion
Fibrinogen
blood coagulation
Thrombocytopenia
in-vitro experiments
FGTW
Fit2012
factor I
Fibrin
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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

Primary outcomes:
measure: 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
timeFrame: 1 hour after platelet transfusion
Secondary outcomes:
measure: Assessment of the difference in the response profile of Blood cell count (EDTA blood sample)
timeFrame: before and 1 hour after platelet transfusion
measure: Standard coagulation tests as aPTT, PT, fibrinogen and FXIII
timeFrame: before and 1 hour after platelet transfusion
measure: Further bleeding management system(ROTEM®)parameters
timeFrame: before and one hour after platelet transfusion
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Central Institution for Blood Transfution and Immunology
state: Tirol
city: Innsbruck
country: Austria
facility: Department for Anesthesia and Intensive Care Medicine
state: Tirol
city: Innsbruck
country: Austria
facility: General and Surgical Intensive Care Medicine
state: Tirol
city: Aarhus
country: Denmark
facility: Faculty of Health Sciences, Centre for Haemophilia and Thrombosis, Aarhus University Hospital
state: Skejby
city: Aarhus
country: Denmark
facility: Faculty of Health Sciences, Department for Anaesthesia and Critical Care Medicine
state: Skejby
Study officials:
affiliation: General and Surgical Intensive Care Medicine, Medical University Innsbruck
name: Dietmar Fries, Univ-Prof.Dr
role: PRINCIPAL_INVESTIGATOR
References: