Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01143909
First received: June 14, 2010
Last updated: June 14, 2013
Last verified: June 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
  • onset of acute lung injury within 48 hours. [ Time Frame: 48 hours within the intervention ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Additional 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
Study First Received: June 14, 2010
Last Updated: June 14, 2013
Health Authority: Netherlands: Dutch Health Care Inspectorate
Netherlands: Medical Ethics Review Committee (METC) - Academic Medical Centre Amsterdam
Netherlands: ZonMw, Netherlands Organisation for Health Research and Development

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:
Blood Coagulation Disorders
Hemorrhage
Hemostatic Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014