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Transfusion of Fresh Frozen Plasma in Non-bleeding Intensive Care Unit (ICU) Patients (TOPIC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01143909
First Posted: June 15, 2010
Last Update Posted: June 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  Purpose
With the aim to restrict inappropriate fresh frozen plasma (FFP) transfusions to critically ill patients, a randomized clinical trial will be conducted in a subgroup of intensive care (ICU) patients undergoing an invasive procedure. The objective is to assess the effectiveness and costs of omitting prophylactic FFP transfusion compared to current practice of prophylactic transfusion, in non-bleeding ICU patients with a coagulopathy.

Condition Intervention
Blood Coagulation Disorders Hemorrhage Other: omitting FFP transfusion before an intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Transfusion of Fresh Frozen Plasma in Non-bleeding ICU Patients

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Procedure-related relevant bleeding, occurring within 24 hours after the procedure. [ Time Frame: 24 hours after the procedure ]

    Relevant bleeding will be defined using a validated tool for assessment of bleeding in the critically ill.

    An assessment of bleeding will be standardized and performed by an independent research physician or intensivist blinded to the transfusion strategy 1 and 24 hours after the procedure and when clinically indicated.



Secondary Outcome Measures:
  • minor bleeding within 24 hours [ Time Frame: within 24 hours of the procedure ]
  • onset of acute lung injury within 48 hours. [ Time Frame: 48 hours within the intervention ]
    Lung injury will be evaluated by P/F ratio, change in ventilator settings, chest x-ray and Lung Injury Score.

  • effect of FFP transfusion on coagulation parameters [ Time Frame: within 24 hours of transfusion of FFP ]
    a range of coagulation parameters will be evaluated to assess efficacy of FFP transfusion in these patients

  • evaluation of costs [ Time Frame: up to 28 days after inclusion ]
    Evaluation of costs in the two different groups will be made. Length of stay, number of ventilation days, differences in medication use, all will be taken into account.


Enrollment: 81
Study Start Date: May 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: No FFP transfusion prior to intervention
Patients with a coagulopathy (INR 1,5-3,0), who are randomized to omitting transfusion of fresh frozen plasma before they undergo an intervention.
Other: omitting FFP transfusion before an intervention
In the interventional group FFP transfusion is omitted before performing a procedure (e.g. placement of central venous catheter, tracheostomy, chest tube)
No Intervention: FFP transfusion prior to intervention
Patients with a coagulopathy (INR 1,5-3,0), who are randomized to transfusion of fresh frozen plasma before they undergo an intervention. This is considered standard care.

Detailed Description:

Rationale: Fresh frozen plasma (FFP) is an effective therapy to correct for a deficiency of multiple coagulation factors during bleeding. In past years, use of FFP has increased, in particular in patients on the Intensive Care Unit (ICU), and has expanded to include prophylactic use in patients with a coagulopathy prior to undergoing an invasive procedure. Retrospective studies suggest that prophylactic use of FFP does not prevent bleeding, but carries the risk of transfusion-related morbidity. However, up to 50% of FFP is administered to non-bleeding ICU patients.

Objective: With the aim to restrict inappropriate FFP transfusions to critically ill patients, a randomized clinical trial will be conducted in a subgroup of ICU patients with a coagulopathy undergoing an invasive procedure. The objective is to assess the effectiveness and costs of prophylactic FFP transfusion (current practice) compared to no prophylactic transfusion, in non-bleeding ICU patients with a coagulopathy, prior to undergoing an invasive procedure (e.g. placement of central venous catheter, tracheostomy, chest tube).

Study design: Prospective, multicentre, randomized, open-label, blinded end point evaluation (PROBE) design.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years and older
  • INR >1.5 and <3.0
  • undergoing invasive procedure (insertion of a central venous catheter, a chest drain, percutaneous tracheostomy)

Exclusion Criteria:

  • clinically overt bleeding at the time of the procedure (excludes minor epistaxis, minor gum bleeding, microscopic hematuria, superficial bruises, or normal menses)
  • thrombocytopenia of < 30 x 109/L.
  • use of abciximab, tirofiban, ticlopidine or activated protein C
  • use of heparin < 1 hour prior to the procedure, or low molecular weight heparin in therapeutic doses < 12 hours prior to procedure
  • history of congenital or acquired coagulation factor deficiency or bleeding diathesis
  • no informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143909


Locations
Netherlands
Academic Medical Centre - University of Amsterdam
Amsterdam, Netherlands, 1105 AZ
Ter Gooi Ziekenhuizen
Hilversum, Netherlands, 1231 XZ
Leids Universitair Medisch Centrum
Leiden, Netherlands, 2333 XZ
Diakonessenhuis
Utrecht, Netherlands, 3582 KE
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Nicole P Juffermans, MD, PhD Academic Medical Centre - University of Amsterdam
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: N.P. Juffermans, MD, PhD, Academic Medical Centre - University of Amsterdam
ClinicalTrials.gov Identifier: NCT01143909     History of Changes
Other Study ID Numbers: ZonMw-80823109710069
NTR2262 ( Registry Identifier: Dutch Trial Register )
First Submitted: June 14, 2010
First Posted: June 15, 2010
Last Update Posted: June 17, 2013
Last Verified: June 2010

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Fresh frozen plasma
Coagulopathy
Intensive care
Adverse effects
Lung injury

Additional relevant MeSH terms:
Hemorrhage
Blood Coagulation Disorders
Hemostatic Disorders
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders