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

NCT01143909 | Completed DMC

• 2 other identifiers: ZonMw-80823109710069NTR2262
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Blood Coagulation Disorders; Hemorrhage

Keywords

Fresh frozen plasma; Coagulopathy; Intensive care; Adverse effects; Lung injury

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• minor bleeding within 24 hours

  within 24 hours of the procedure

• onset of acute lung injury within 48 hours.

  48 hours within the intervention

• effect of FFP transfusion on coagulation parameters

  within 24 hours of transfusion of FFP

• evaluation of costs

  up to 28 days after inclusion

Study Arms (2)

No FFP transfusion prior to intervention

EXPERIMENTAL

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

FFP transfusion prior to intervention

NO 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.

Interventions

omitting FFP transfusion before an intervention OTHER

In the interventional group FFP transfusion is omitted before performing a procedure (e.g. placement of central venous catheter, tracheostomy, chest tube)

No FFP transfusion prior to intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• INR \>1.5 and \<3.0
• undergoing invasive procedure (insertion of a central venous catheter, a chest drain, percutaneous tracheostomy)

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (4)

Diakonessenhuis

Utrecht, Utrecht, 3582 KE, Netherlands

Location

Academic Medical Centre - University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Ter Gooi Ziekenhuizen

Hilversum, 1231 XZ, Netherlands

Location

Leids Universitair Medisch Centrum

Leiden, 2333 XZ, Netherlands

Location

Related Publications (3)

• Straat M, Muller MC, Meijers JC, Arbous MS, Spoelstra-de Man AM, Beurskens CJ, Vroom MB, Juffermans NP. Effect of transfusion of fresh frozen plasma on parameters of endothelial condition and inflammatory status in non-bleeding critically ill patients: a prospective substudy of a randomized trial. Crit Care. 2015 Apr 15;19(1):163. doi: 10.1186/s13054-015-0828-6.

  PMID: 25880761 DERIVED

• Muller MC, Straat M, Meijers JC, Klinkspoor JH, de Jonge E, Arbous MS, Schultz MJ, Vroom MB, Juffermans NP. Fresh frozen plasma transfusion fails to influence the hemostatic balance in critically ill patients with a coagulopathy. J Thromb Haemost. 2015 Jun;13(6):989-97. doi: 10.1111/jth.12908. Epub 2015 Apr 18.

  PMID: 25809519 DERIVED

• Muller 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.

  PMID: 22196464 DERIVED

MeSH Terms

Conditions

Blood Coagulation Disorders; Hemorrhage; Hemostatic Disorders; Lung Injury

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Study Officials

• Nicole P Juffermans, MD, PhD

  Academic Medical Centre - University of Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 15, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 17, 2013

Record last verified: 2010-06

Locations

NL (4)