NCT06144125

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
3mo left

Started Mar 2026

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress61%
Mar 2026Oct 2026

First Submitted

Initial submission to the registry

November 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
2.3 years until next milestone

Study Start

First participant enrolled

March 27, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

November 16, 2023

Last Update Submit

June 15, 2026

Conditions

Cardiac Valve Disease

Keywords

prothrombin complex concentratefresh frozen plasmacoagulationbleedingcardiac surgery

Outcome Measures

Primary Outcomes (1)

  • treatment time

    duration from the time of diagnosing CT-EXTEM prolongation (ordering PCC or FFP) to the time achieving bleeding control (completing administration of PCC or FFP)

    1 min

Secondary Outcomes (11)

  • Red Blood Cell amount

    I hour

  • FFP amount

    1 hour

  • Platelet amount

    1 hour

  • cryoprecipiate amount

    1 hour

  • CT-EXTEM change

    1 min

  • +6 more secondary outcomes

Other Outcomes (1)

  • Thromboembolism complication

    24 hour

Study Arms (2)

fresh frozen plasma

ACTIVE COMPARATOR

according to the Rotational thromboelastometry (ROTEM) test, CT-EXTEM prolongation, fresh frozen plasma transfusion (FFP) 10-15 ml/kg is performed

Biological: fresh frozen plasma

prothrombin complex concentrate

EXPERIMENTAL

according to the Rotational thromboelastometry (ROTEM) test, CT-EXTEM prolongation, prothrombin complex concentrate (PCC) 10-15 IU/kg is administered

Biological: prothrombin complex concentrate

Interventions

fresh frozen plasmaBIOLOGICAL

transfusion of fresh frozen plasma

fresh frozen plasma
prothrombin complex concentrateBIOLOGICAL

prothrombin complex concentrate administration

prothrombin complex concentrate

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing cardiac surgery

You may not qualify if:

  • thrombocytopenia
  • oral anti-coagulant
  • anti platelet agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konkuk University Medical Center

Seoul, Seoul, 05030, South Korea

RECRUITING

MeSH Terms

Conditions

Heart Valve DiseasesHemophilia BThrombosisHemorrhage

Interventions

Factor IX

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBlood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-LinkedEmbolism and ThrombosisVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Enzyme PrecursorsEnzymes and CoenzymesBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological Factors

Study Officials

  • Tae-Yop Kim, MD PhD

    Konkuk University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tae-Yop KIm, MD PhD

CONTACT

+82-10-8811-6942taeyop@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients are randomly divided into two groups (experimental vs control groups).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 22, 2023

Study Start

March 27, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

June 17, 2026

Record last verified: 2026-06

Locations

KR(1)