Recruiting
Phase 3

Plasma Transfusion

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT02561026

Conditions

Blood Coagulation Disorders

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Frozen plasma

Study Details

Brief summary:

Frozen plasma (FP) is commonly transfused to patients with abnormal coagulation results prior to medical procedures associated with a risk of bleeding (e.g. involving a needle or incision). The most frequent group that requires FP transfusions are patients admitted to an intensive care unit. These patients frequently have abnormal coagulation tests and also frequently require invasive medical procedures that can be associated with bleeding. While FP transfusions can improve abnormal coagulation test results, there is no evidence to suggest that prophylactic FP transfusions will reduce bleeding associated with medical procedures in patients with mild coagulation abnormalities. Additionally, it is known that important adverse complications occur with FP transfusions.

The investigators will undertake a pilot randomized controlled trial in non-bleeding ICU patients who require an invasive medical procedure (central venous catheterization, chest tube, thoracocentesis, paracentesis, biopsy, fluid drainage) in 3 Canadian hospitals. Patients with an abnormal coagulation test (INR between 1.5 to 2.5) will receive a FP transfusion or no treatment prior to an invasive procedure.

The primary outcome for this pilot study will be feasibility (the number of patients enrolled per month). Other important outcomes will include those that will be evaluated in the definitive trial including bleeding post procedure, red cell transfusions, adverse transfusion reactions, mortality and hospital length of stay.

The objective of the study is to enrol 80 patients over 2 years in 3 Canadian hospitals.

Conditions

Blood Coagulation Disorders

Study ID

NCT02561026

Start date

Jan, 2016

Status verified date

Mar, 2018

Completion date

Feb, 2019

Anticipated

Primary completion date

Aug, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 or greater
  • Admission or planned admission (e.g. patients in emergency department who are being seen by the ICU team) to an intensive care unit.
  • An elevated INR between 1.5 and 2.5.
  • Requiring an invasive procedure in the next 24 hours including central venous line, arterial line, paracentesis, thoracocentesis, bronchoscopy, endoscopy, and ultrasound guided biopsy (mass or organ) or fluid drainage.

Exclusion Criteria:

  • Active bleeding, defined as visible or suspected blood loss in last 48 hours, resulting in a fall in hemoglobin greater than or equal to 20 g/L, requiring a red cell transfusion or an intervention to control bleeding.
  • Full dose therapeutic anticoagulation with warfarin, heparin, low molecular weight heparin, or other novel oral anticoagulants.
  • Congenital bleeding disorders including hemophilia, von Willebrand Disease or platelet function disorders.
  • Acquired coagulation factor deficiencies.
  • Frozen plasma transfusion during this ICU admission.
  • Use of other hemostatic blood products (recombinant factor VIIa, prothrombin complex concentrate, cryoprecipitate, fibrinogen concentrate) during the ICU admission
  • Previously enrolment in the study.

Patients will not be excluded for thrombocytopenia or anti-platelet drugs. As a pilot trial for a pragmatic large randomized controlled trial, both thrombocytopenic patients and patients on anti- platelet agents will be enrolled as they are routinely encountered in clinical practice. Specific therapy (i.e. platelet transfusions) will not be mandated, but left to local routine practice. Information regarding platelet counts, anti-platelet medications, platelet transfusions and other hemostatic therapies will be collected.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: FP Transfusion

patients randomized to receive frozen plasma transfusions

no intervention: no FP Transfusion

patients not receiving frozen plasma transfusions

Interventions

Frozen plasma

patients randomized to receive frozen plasma transfusions

Primary outcome measure

  • Recruitment feasibility, as measured by the number of participants screened per month at each center. [ Time Frame: monthly, up to 21 months ]

Central Contacts and Locations

Central contacts

Elizabeth Chatelain, BScN

613-737-8899echatelain@ohri.ca

Locations

Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Alan Tinmouth, MD

737-8899atinmouth@ohri.ca

Principal Investigator:

Alan Tinmouth, MD MSc RCPSC

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Mar 30, 2018

Last verified

Mar, 2018

Keywords

  • Frozen plasma
  • INR
  • procedures

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2018-03-30.