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

Hemorrhage Clinical Trial

— TOPIC  

Official title:

Transfusion of Fresh Frozen Plasma in Non-bleeding ICU Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143909
• Other study ID #: ZonMw-80823109710069
• Secondary ID: NTR2262
• Status: Completed
• Phase: N/A
• First received: June 14, 2010
• Last updated: June 14, 2013
• Start date: May 2010
• Est. completion date: June 2013

Study information

• Verified date: June 2010
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care InspectorateNetherlands: Medical Ethics Review Committee (METC) - Academic Medical Centre AmsterdamNetherlands: ZonMw, Netherlands Organisation for Health Research and Development
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemorrhage
• Hemostatic Disorders

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)

Locations

Country	Name	City	State
Netherlands	Academic Medical Centre - University of Amsterdam	Amsterdam
Netherlands	Ter Gooi Ziekenhuizen	Hilversum
Netherlands	Leids Universitair Medisch Centrum	Leiden
Netherlands	Diakonessenhuis	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure-related relevant bleeding, occurring within 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.	24 hours after the procedure	Yes
Secondary	minor bleeding within 24 hours		within 24 hours of the procedure	Yes
Secondary	onset of acute lung injury within 48 hours.	Lung injury will be evaluated by P/F ratio, change in ventilator settings, chest x-ray and Lung Injury Score.	48 hours within the intervention	Yes
Secondary	effect of FFP transfusion on coagulation parameters	a range of coagulation parameters will be evaluated to assess efficacy of FFP transfusion in these patients	within 24 hours of transfusion of FFP	No
Secondary	evaluation of costs	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.	up to 28 days after inclusion	No