Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage; Blood Coagulation Disorders
• Intervention / Treatment: Biological: Fresh frozen plasma transfusion

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University, The Johns Hopkins Hospital
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Robert Wood Johnson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin Level	Change from pre-procedure hemoglobin to lowest within 2 days after procedure	within 2 days post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Red Blood Cell Transfusions	Differences in number of units of red blood cell transfusions between the two study arms	within 2 days post procedure
Number of Participants With Transfusion Associated Cardiac Overload (TACO)	Difference in rates between the two study arms	within 2 days post procedure
Number of Participants With Transfusion Related Acute Lung Injury (TRALI).	Difference in rates between the two study arms	with 2 days post procedure
Number of Participants With Major Bleed	2g/dL or greater fall in hemoglobin level	with 2 days post procedure
Change in International Normalized Ratio (INR) Level Post Procedure	Change from pre-procedure INR level	day of procedure
Change in INR Level Day 1	Change from pre-procedure INR level	day 1 post procedure
Change in INR Level Day 2	Change from pre-procedure INR level	day 2 post procedure
Mortality (Number of Participants)	Death	in-hospital up to 7 days
Number of Participants With Infection	Pneumonia or blood stream infection	within 2 days post procedure
Number of Participants With ICU Admission	new admission to the intensive care unit	within 2 days post procedure

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: Johns Hopkins University; National Heart, Lung, and Blood Institute (NHLBI); University of Pittsburgh; University of Washington
• Investigators: Study Chair: Jeffrey L Carson, MD, Rutgers Robert Wood Johnson Medical School

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2016
• Primary Completion (Actual): June 28, 2019
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: December 16, 2015
• First Submitted That Met QC Criteria: December 17, 2015
• First Posted (Estimate): December 22, 2015

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Bleeding; Fresh frozen plasma
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage
• Other Study ID Numbers: Pro20150001801; 1R34HL125804-01A1 (U.S. NIH Grant/Contract)