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Transfusion of Plasma Prior to Invasive Procedures Pilot Trial (TOPPIT) (TOPPIT)

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ClinicalTrials.gov Identifier: NCT02561026
Recruitment Status : Recruiting
First Posted : September 25, 2015
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.


Condition or disease Intervention/treatment Phase
Blood Coagulation Disorders Biological: Frozen plasma Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Transfusion of Plasma Prior to Invasive Procedures Pilot Trial (TOPPIT)
Study Start Date : January 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FP Transfusion
patients randomized to receive frozen plasma transfusions
Biological: Frozen plasma
patients randomized to receive frozen plasma transfusions

No Intervention: no FP Transfusion
patients not receiving frozen plasma transfusions



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

Secondary Outcome Measures :
  1. Bleeding assessment (Changes in hemoglobin and red cell transfusions as measured by a standardized bleeding assessment tool) [ Time Frame: 24-48 hours post-procedure ]
    Changes in hemoglobin and red cell transfusions as measured by a standardized bleeding assessment tool.

  2. Ventilator requirement [ Time Frame: 24-48 hours post frozen plasma transfusion ]
    Requirement for mechanical ventilation as it pertains to the feasibility of the study procedures.

  3. Overall length of stay [ Time Frame: Length of stay will be measured as the number of days elapsed between hospital admission and hospital discharge dates up to 21 months. ]
    Overall length of stay = discharge date - admission date

  4. ICU length of stay [ Time Frame: ICU length of stay will be measured as the number of days elapsed between Intensive Care Unit admission and discharge dates up to 21months. ]
    ICU length of stay = ICU discharge date - ICU admission date



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02561026


Contacts
Contact: Elizabeth Chatelain, BScN 613-737-8899 ext 71264 echatelain@ohri.ca

Locations
Canada, Ontario
Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Alan Tinmouth, MD    737-8899 ext 73914    atinmouth@ohri.ca   
Principal Investigator: Alan Tinmouth, MD MSc RCPSC         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Alan Tinmouth, MD MSc The Ottawa Hospital, Ottawa Hospital Research Institute

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02561026     History of Changes
Other Study ID Numbers: 20150215-01H
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

Keywords provided by Ottawa Hospital Research Institute:
Frozen plasma
INR
procedures

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders