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

NCT02561026 | Unknown Phase 3 DMC

• 1 other identifier: 20150215-01H
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Frozen plasma; INR; procedures

Outcome Measures

Primary Outcomes (1)

• Recruitment feasibility, as measured by the number of participants screened per month at each center.

  monthly, up to 21 months

Secondary Outcomes (4)

• Bleeding assessment (Changes in hemoglobin and red cell transfusions as measured by a standardized bleeding assessment tool)

  24-48 hours post-procedure

• Ventilator requirement

  24-48 hours post frozen plasma transfusion

• Overall length of stay

  Length of stay will be measured as the number of days elapsed between hospital admission and hospital discharge dates up to 21 months.

• ICU length of stay

  ICU length of stay will be measured as the number of days elapsed between Intensive Care Unit admission and discharge dates up to 21months.

Study Arms (2)

FP Transfusion

EXPERIMENTAL

patients randomized to receive frozen plasma transfusions

Biological: Frozen plasma

no FP Transfusion

NO INTERVENTION

patients not receiving frozen plasma transfusions

Interventions

Frozen plasma BIOLOGICAL

patients randomized to receive frozen plasma transfusions

FP Transfusion

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

MeSH Terms

Conditions

Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Alan Tinmouth, MD MSc

  The Ottawa Hospital, Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Chatelain, BScN

CONTACT

613-737-8899; echatelain@ohri.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: September 25, 2015
• Study Start: January 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: February 1, 2019
• Last Updated: March 30, 2018

Record last verified: 2018-03

Locations

CA (1)