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

Blood Clotting Clinical Trial

— FiT2012  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01955811
• Other study ID #: FiT2012
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2013
• Last updated: March 22, 2016
• Start date: December 2012
• Est. completion date: August 2014

Study information

• Verified date: March 2016
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria : Federal Ministry for Labour, Health, and Social Affairs
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Blood Clotting
• Blood Platelet Transfusion
• Thrombocytopenia

Intervention

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.

Locations

Country	Name	City	State
Austria	Central Institution for Blood Transfution and Immunology	Innsbruck	Tirol
Austria	Department for Anesthesia and Intensive Care Medicine	Innsbruck	Tirol
Austria	General and Surgical Intensive Care Medicine	Innsbruck	Tirol
Denmark	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

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Countries where clinical trial is conducted

Austria,  Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		1 hour after platelet transfusion	No
Secondary	Assessment of the difference in the response profile of Blood cell count (EDTA blood sample)		before and 1 hour after platelet transfusion	No
Secondary	Standard coagulation tests as aPTT, PT, fibrinogen and FXIII		before and 1 hour after platelet transfusion	No
Secondary	Further bleeding management system(ROTEM®)parameters	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	No