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Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Rutgers, The State University of New Jersey
Sponsor:
Collaborators:
University of Pittsburgh
Johns Hopkins University
University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jeffrey L Carson, MD, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT02637427
First received: December 16, 2015
Last updated: November 29, 2016
Last verified: November 2016
  Purpose
The purpose of this study is to evaluate prophylactic fresh frozen plasma transfusion in patients with moderately elevated international normalized ratios (INR) prior to undergoing an invasive procedure.

Condition Intervention Phase
Blood Coagulation Disorders
Hemorrhage
Biological: Fresh frozen plasma transfusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Change in Hemoglobin Level [ Time Frame: within 2 days post procedure ] [ Designated as safety issue: No ]
    Change from pre-procedure hemoglobin

  • Trial Feasibility (Rates of eligible and enrolled study subjects) [ Time Frame: 16 month study enrollment ] [ Designated as safety issue: No ]
    Rates of eligible and enrolled study subjects


Secondary Outcome Measures:
  • Red Blood Cell Transfusion [ Time Frame: within 2 days post procedure ] [ Designated as safety issue: No ]
    Differences in number of units of red blood cell transfusions between the two study arms

  • Transfusion Associated Cardiac Overload (TACO) [ Time Frame: within 2 days post procedure ] [ Designated as safety issue: No ]
    Difference in rates between the two study arms

  • Transfusion Related Acute Lung Injury (TRALI). [ Time Frame: with 2 days post procedure ] [ Designated as safety issue: No ]
    Difference in rates between the two study arms

  • Major Bleed [ Time Frame: with 2 days post procedure ] [ Designated as safety issue: No ]
    2g/dL or greater fall in hemoglobin level

  • Change in INR Level Post Procedure [ Time Frame: day of procedure ] [ Designated as safety issue: No ]
    Change from pre-procedure INR level

  • Change in INR Level Day 1 [ Time Frame: day 1 post procedure ] [ Designated as safety issue: No ]
    Change from pre-procedure INR level

  • Change in INR Level Day 2 [ Time Frame: day 2 post procedure ] [ Designated as safety issue: No ]
    Change from pre-procedure INR level

  • Mortality [ Time Frame: in-hospital up to 30 days ] [ Designated as safety issue: No ]
    Death

  • Infection [ Time Frame: within 2 days post procedure ] [ Designated as safety issue: No ]
    Pneumonia or blood stream infection

  • ICU Admission [ Time Frame: within 2 days post procedure ] [ Designated as safety issue: No ]
    new admission to the intensive care unit


Estimated Enrollment: 110
Study Start Date: January 2016
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fresh frozen plasma transfusion
Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units)
Biological: Fresh frozen plasma transfusion
Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)
No Intervention: No transfusion
No transfusions prior to the procedure

Detailed Description:

Fresh frozen plasma is used very frequently in the US. Many plasma transfusions are given prior to a procedure in order to correct perceived bleeding risk, yet there is little evidence to support that use of plasma reduces bleeding. There has never been an adequately powered trial to establish the efficacy of plasma and document the risks. This pilot study will evaluate the feasibility of conducting a research protocol that will lead to a large scale clinical trial designed to evaluate the treatment effectiveness of prophylactic plasma transfusion in patients with moderately elevated INRs prior to undergoing an invasive procedure outside of the operating room.

Study subjects will be randomly allocated to either receive either plasma transfusion prior to the procedure, or to no treatment. Study outcomes will be compared between the two study arms. Recruitment rates, protocol adherence, and rates of study outcomes will be assessed to determine the feasibility of the large scale trial.

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. INR level between 1.50 and 2.50 inclusive
  2. undergoing an invasive procedure at the bedside, endoscopy laboratory, or in radiology

Exclusion Criteria:

  1. undergoing a surgical procedure in the operating room;
  2. active bleeding;
  3. undergoing a procedure involving or proximal to the central nervous system or spinal cord;
  4. cardiac catheterization,
  5. using 4 factor plasma concentrates
  6. using systemic heparin/heparinoid therapy, direct factor X inhibitors and other anticoagulants for which plasma will not correct prolonged INR;
  7. platelet count less than 50,000/ul,
  8. congenital coagulation disorders;
  9. acquired disorders (i.e., lupus anticoagulant) for which plasma will not correct the disorder;
  10. women who are pregnant and;
  11. unwillingness to consider blood transfusion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02637427

Contacts
Contact: Jeffrey L Carson, MD 732-235-7122 jeffrey.carson@rutgers.edu
Contact: Helaine Noveck, MPH 732-235-6581 helaine.noveck@rutgers.edu

Locations
United States, Maryland
Johns Hopkins University, The Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Paul M Ness, MD    410-502-8122    pness@jhmi.edu   
Principal Investigator: Paul M Ness, MD         
United States, New Jersey
Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Jeffrey L Carson, MD    732-235-7122    jeffrey.carson@rutgers.edu   
Principal Investigator: Jeffrey L Carson, MD         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
University of Pittsburgh
Johns Hopkins University
University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Study Chair: Jeffrey L Carson, MD Rutgers-Robert Wood Johnson Medical School
  More Information

Responsible Party: Jeffrey L Carson, MD, Principal Investigator, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT02637427     History of Changes
Other Study ID Numbers: Pro20150001801  1R34HL125804-01A1 
Study First Received: December 16, 2015
Last Updated: November 29, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
Fresh frozen plasma
Bleeding

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

ClinicalTrials.gov processed this record on December 06, 2016