Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Non-cardiac Surgery

December 29, 2023 updated by: Tae-Yop Kim, MD PhD, Konkuk University Medical Center

Prothrombin Complex Concentrate and Fresh Frozen Plasma in Viscoelastic Test-based Goal-directed Bleeding Management in Non-Cardiac Surgery

The primary endpoint of this study is the completion time of hemostasis treatment when administered Fresh frozen plasma (FFP) and frozen powder coagulation factor concentrate (PCC) in goal-directed bleeding management for non-cardiac surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

154

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Tae-Yop Kim, MD PhD
  • Phone Number: +82-10-8811-6942
  • Email: taeyop@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • patients undergoing spine surgery
  • patients undergoing open radical prostatectomy
  • patients undergoing hip arthroplasty
  • patients undergoing knee arthroplasty

Exclusion Criteria:

  • Patients taking oral anticoagulants,
  • Patient taking recombinant factor VII a
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: fresh frozen plasma
according to the Thromboelastography (TEG) test, CK r-time prolongation, fresh frozen plasma transfusion (FFP) is performed
Biological: fresh frozen plasma
transfusion of fresh frozen plasma
Experimental: prothrombin complex concentrate
according to the Thromboelastography (TEG) test, CK r-time prolongation,prothrombin complex concentrate (PCC) administration
Biological: prothrombin complex concentrate
prothrombin complex concentrate administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
duration from the time diagnosing r-time prolongation to the time achieving bleeding control
Time Frame: 1 min
1 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet amount
Time Frame: 1 hour
Platelet transfusion amount during surgery
1 hour
Red Blood Cell amount
Time Frame: 1 hour
Red Blood Cell transfusion amount during surgery
1 hour
FFP amount
Time Frame: 1 hour
FFP transfusion amount during surgery
1 hour
r-time
Time Frame: 10 min
CK r-time after PCC or FFP
10 min
CRT-MA
Time Frame: 10 min
CRT-MA after PCC or FFP
10 min
CFF-MA
Time Frame: 10 min
CFF-MA after PCC or FFP
10 min
Bleeding
Time Frame: 6 hour
Postoperative bleeding amount
6 hour
oxygenation profile
Time Frame: 1 hour
PaO2/FiO2 ratio
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konkuk University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

November 16, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Actual)

November 22, 2023

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC22195220002002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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