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

June 14, 2010
June 14, 2013
May 2010
June 2013   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01143909 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Transfusion of Fresh Frozen Plasma in Non-bleeding Intensive Care Unit (ICU) Patients
Transfusion of Fresh Frozen Plasma in Non-bleeding ICU Patients

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Blood Coagulation Disorders
  • Hemorrhage
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)
  • 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.
    Intervention: Other: omitting FFP transfusion before an intervention
  • 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.
Müller MC, de Jonge E, Arbous MS, Spoelstra-de Man AM, Karakus A, Vroom MB, Juffermans NP. Transfusion of fresh frozen plasma in non-bleeding ICU patients--TOPIC trial: study protocol for a randomized controlled trial. Trials. 2011 Dec 23;12:266. doi: 10.1186/1745-6215-12-266.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01143909
ZonMw-80823109710069, NTR2262
Yes
N.P. Juffermans, MD, PhD, Academic Medical Centre - University of Amsterdam
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ZonMw: The Netherlands Organisation for Health Research and Development
Principal Investigator: Nicole P Juffermans, MD, PhD Academic Medical Centre - University of Amsterdam
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP