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

NCT01955811 | Completed Phase 4

• 1 other identifier: FiT2012
• Study Type: interventional
• Target: 130
• Locations: 2 countries
• Sites: 5

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.

Conditions

Blood Platelet Transfusion; Blood Clotting

Keywords

platelet transfusion; Fibrinogen; blood coagulation; Thrombocytopenia; in-vitro experiments; FGTW; Fit2012; factor I; Fibrin

Outcome Measures

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

  1 hour after platelet transfusion

Secondary Outcomes (3)

• 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

Study Arms (1)

Platelet concentrate transfusion and Human Fibrinogen

OTHER

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

Interventions

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.

Platelet concentrate transfusion and Human Fibrinogen

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient with the clinical need for platelet transfusion
• age: 18 - 85 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (5)

Central Institution for Blood Transfution and Immunology

Innsbruck, Tyrol, 6020, Austria

Location

Department for Anesthesia and Intensive Care Medicine

Innsbruck, Tyrol, 6020, Austria

Location

General and Surgical Intensive Care Medicine

Innsbruck, Tyrol, 6020, Austria

Location

Faculty of Health Sciences, Centre for Haemophilia and Thrombosis, Aarhus University Hospital

Aarhus, Skejby, 8200, Denmark

Location

Faculty of Health Sciences, Department for Anaesthesia and Critical Care Medicine

Aarhus, Skejby, 8200, Denmark

Location

MeSH Terms

Conditions

Thrombosis; Thrombocytopenia

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Dietmar Fries, Univ-Prof.Dr

  General and Surgical Intensive Care Medicine, Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ao. Univ.-Prof. Dr.

Study Record Dates

• First Submitted: September 2, 2013
• First Posted: October 8, 2013
• Study Start: December 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 23, 2016

Record last verified: 2016-03

Locations

DK (2); AU (3)