NCT02637427

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2016

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 26, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
10 months until next milestone

Results Posted

Study results publicly available

August 17, 2021

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

3.3 years

First QC Date

December 16, 2015

Results QC Date

July 2, 2021

Last Update Submit

August 16, 2021

Conditions

Blood Coagulation DisordersHemorrhage

Keywords

Fresh frozen plasmaBleeding

Outcome Measures

Primary Outcomes (1)

  • Change in Hemoglobin Level

    Change from pre-procedure hemoglobin to lowest within 2 days after procedure

    within 2 days post procedure

Secondary Outcomes (10)

  • Number of Red Blood Cell Transfusions

    within 2 days post procedure

  • Number of Participants With Transfusion Associated Cardiac Overload (TACO)

    within 2 days post procedure

  • Number of Participants With Transfusion Related Acute Lung Injury (TRALI).

    with 2 days post procedure

  • Number of Participants With Major Bleed

    with 2 days post procedure

  • Change in International Normalized Ratio (INR) Level Post Procedure

    day of procedure

  • +5 more secondary outcomes

Study Arms (2)

Fresh frozen plasma transfusion

EXPERIMENTAL

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

No transfusion

NO INTERVENTION

No transfusions prior to the procedure

Interventions

Fresh frozen plasma transfusionBIOLOGICAL

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

Fresh frozen plasma transfusion

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • undergoing a surgical procedure in the operating room;
  • active bleeding;
  • undergoing a procedure involving or proximal to the central nervous system or spinal cord;
  • cardiac catheterization,
  • using 4 factor plasma concentrates
  • using systemic heparin/heparinoid therapy, direct factor X inhibitors and other anticoagulants for which plasma will not correct prolonged INR;
  • platelet count less than 50,000/ul,
  • congenital coagulation disorders;
  • acquired disorders (i.e., lupus anticoagulant) for which plasma will not correct the disorder;
  • women who are pregnant and;
  • unwillingness to consider blood transfusion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins University, The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Blood Coagulation DisordersHemorrhage

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Jeffrey L Carson, MD
Organization
Rutgers, The State University of New Jersey
Jeffrey.Carson@Rutgers.edu
732-235-7122

Study Officials

  • Jeffrey L Carson, MD

    Rutgers Robert Wood Johnson Medical School

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 16, 2015

First Posted

December 22, 2015

Study Start

February 26, 2016

Primary Completion

June 28, 2019

Study Completion

November 1, 2020

Last Updated

August 18, 2021

Results First Posted

August 17, 2021

Record last verified: 2021-08

Locations

US(2)