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

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Completed

Conditions: Hemorrhage; Blood Coagulation Disorders

Treatments: Other: omitting FFP transfusion before an intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01143909

NTR2262 (Registry Identifier)

ZonMw-80823109710069

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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81 participants in 2 patient groups

No FFP transfusion prior to intervention

Experimental group

Description:

Patients with a coagulopathy (INR 1,5-3,0), who are randomized to omitting transfusion of fresh frozen plasma before they undergo an intervention.

Treatment:

Other: omitting FFP transfusion before an intervention

FFP transfusion prior to intervention

No Intervention group

Description:

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.