Status:
COMPLETED
Transfusion of Fresh Frozen Plasma in Non-bleeding Intensive Care Unit (ICU) Patients
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Blood Coagulation Disorders
Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 u...
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 pati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT01143909
Start Date
May 1 2010
End Date
June 1 2013
Last Update
June 17 2013
Active Locations (4)
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1
Diakonessenhuis
Utrecht, Utrecht, Netherlands, 3582 KE
2
Academic Medical Centre - University of Amsterdam
Amsterdam, Netherlands, 1105 AZ
3
Ter Gooi Ziekenhuizen
Hilversum, Netherlands, 1231 XZ
4
Leids Universitair Medisch Centrum
Leiden, Netherlands, 2333 XZ