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

Phase 4

Completed

• Conditions: Blood Platelet Transfusion; Blood Clotting
• Interventions: Drug: Administration of platelet concentrate and taking blood samples

• Registration Number: NCT01955811
• Lead Sponsor: Medical University Innsbruck

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-09-02
• Study First Submitted QC: 2013-09-27
• Study First Posted: 2013-10-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-22
• Last Update Posted: 2016-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Platelet concentrate transfusion and Human Fibrinogen	Administration of platelet concentrate and taking blood samples	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.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Assessment of the difference in the response profile of Blood cell count (EDTA blood sample)	before and 1 hour after platelet transfusion
Standard coagulation tests as aPTT, PT, fibrinogen and FXIII	before and 1 hour after platelet transfusion
Further bleeding management system(ROTEM®)parameters	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)

Trial Locations

Locations (5)

Faculty of Health Sciences, Department for Anaesthesia and Critical Care Medicine; 🇩🇰 Aarhus, Skejby, Denmark

Central Institution for Blood Transfution and Immunology; 🇦🇹 Innsbruck, Tirol, Austria

Faculty of Health Sciences, Centre for Haemophilia and Thrombosis, Aarhus University Hospital; 🇩🇰 Aarhus, Skejby, Denmark

General and Surgical Intensive Care Medicine; 🇦🇹 Innsbruck, Tirol, Austria

Department for Anesthesia and Intensive Care Medicine; 🇦🇹 Innsbruck, Tirol, Austria