Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures

Hemorrhage Clinical Trial

Official title:

Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02637427
• Other study ID #: Pro20150001801
• Secondary ID: 1R34HL125804-01A
• Status: Completed
• Phase: Phase 3
• Start date: February 26, 2016
• Est. completion date: November 2020

Study information

• Verified date: August 2021
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: November 2020
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemorrhage
• Hemostatic Disorders

Intervention

Biological:
• Fresh frozen plasma transfusion
Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)

Locations

Country	Name	City	State
United States	Johns Hopkins University, The Johns Hopkins Hospital	Baltimore	Maryland
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey

Sponsors (5)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Johns Hopkins University, National Heart, Lung, and Blood Institute (NHLBI), University of Pittsburgh, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin Level	Change from pre-procedure hemoglobin to lowest within 2 days after procedure	within 2 days post procedure
Secondary	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
Secondary	Number of Participants With Transfusion Associated Cardiac Overload (TACO)	Difference in rates between the two study arms	within 2 days post procedure
Secondary	Number of Participants With Transfusion Related Acute Lung Injury (TRALI).	Difference in rates between the two study arms	with 2 days post procedure
Secondary	Number of Participants With Major Bleed	2g/dL or greater fall in hemoglobin level	with 2 days post procedure
Secondary	Change in International Normalized Ratio (INR) Level Post Procedure	Change from pre-procedure INR level	day of procedure
Secondary	Change in INR Level Day 1	Change from pre-procedure INR level	day 1 post procedure
Secondary	Change in INR Level Day 2	Change from pre-procedure INR level	day 2 post procedure
Secondary	Mortality (Number of Participants)	Death	in-hospital up to 7 days
Secondary	Number of Participants With Infection	Pneumonia or blood stream infection	within 2 days post procedure
Secondary	Number of Participants With ICU Admission	new admission to the intensive care unit	within 2 days post procedure