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

November 16, 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 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 cardiac surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

152

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 cardiac surgery

Exclusion Criteria:

  • thrombocytopenia
  • oral anti-coagulant
  • anti platelet agents

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 Rotational thromboelastometry (ROTEM) test, CT-EXTEM prolongation, fresh frozen plasma transfusion (FFP) is performed
Biological: fresh frozen plasma
transfusion of fresh frozen plasma
Experimental: prothrombin complex concentrate
according to the Rotational thromboelastometry (ROTEM) test, CT-EXTEM prolongation, prothrombin complex concentrate (PCC) is administered
Biological: prothrombin complex concentrate
prothrombin complex concentrate administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
treatment time
Time Frame: 1 min
duration from the time diagnosing CT-EXTEM prolongation to the time achieving bleeding control
1 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Red Blood Cell amount
Time Frame: I hour
Red Blood Cell transfusion amount during surgery
I hour
FFP amount
Time Frame: 1 hour
Red Blood Cell transfusion amount during surgery
1 hour
Platelet amount
Time Frame: 1 hour
Platelet transfusion amount during surgery
1 hour
CT-EXTEM
Time Frame: 10 min
clotting time-EXTEM after PCC or FFP
10 min
MA-EXTEM
Time Frame: 10 min
Maximal amplitude-EXTEM after PCC or FFP
10 min
MA-FIBTEM
Time Frame: 10 min
Maximal amplitude-FIBTEM after PCC or FFP
10 min
Postoperative bleeding
Time Frame: 24 hour
chest tube drainage at postoperative 24 hour
24 hour

Collaborators and Investigators

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

Sponsor

Konkuk University Medical Center

Investigators

  • Principal Investigator: Tae-Yop Kim, MD PhD, 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 (Estimated)

November 22, 2023

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC22195220002004

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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