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

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2024

Shorter than P25 for phase_4

Status
unknown

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

November 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

November 16, 2023

Last Update Submit

November 16, 2023

Conditions

Cardiac Valve Disease

Outcome Measures

Primary Outcomes (1)

  • treatment time

    duration from the time diagnosing CT-EXTEM prolongation to the time achieving bleeding control

    1 min

Secondary Outcomes (7)

  • Red Blood Cell amount

    I hour

  • FFP amount

    1 hour

  • Platelet amount

    1 hour

  • CT-EXTEM

    10 min

  • MA-EXTEM

    10 min

  • +2 more secondary outcomes

Study Arms (2)

fresh frozen plasma

ACTIVE COMPARATOR

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

Biological: fresh frozen plasma

prothrombin complex concentrate

EXPERIMENTAL

according to the Rotational thromboelastometry (ROTEM) test, CT-EXTEM prolongation, prothrombin complex concentrate (PCC) 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

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Factor IX

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

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 1, 2024

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

November 22, 2023

Record last verified: 2023-11