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

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06144125

Enrollment

100

Registered

2023-11-22

Start date

2026-03-27

Completion date

2026-10-30

Last updated

2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Valve Disease

Keywords

prothrombin complex concentrate, fresh frozen plasma, coagulation, bleeding, cardiac surgery

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.

Interventions

BIOLOGICALfresh frozen plasma

transfusion of fresh frozen plasma

BIOLOGICALprothrombin complex concentrate

prothrombin complex concentrate administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Patients are randomly divided into two groups (experimental vs control groups).

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* patients undergoing cardiac surgery

Exclusion criteria

* thrombocytopenia * oral anti-coagulant * anti platelet agents

Design outcomes

Primary

Measure	Time frame	Description
treatment time	1 min	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)

Secondary

Measure	Time frame	Description
Red Blood Cell amount	I hour	Red Blood Cell transfusion amount during surgery
FFP amount	1 hour	Red Blood Cell transfusion amount during surgery
Platelet amount	1 hour	Platelet transfusion amount during surgery
cryoprecipiate amount	1 hour	amount of cryoprecipitate transfusion
CT-EXTEM change	1 min	clotting time-EXTEM after PCC or FFP
A5-EXTEM change	1 min	clot amplitude at 5 min after clot initiation in EXTEM after PCC or FFP
MCF-EXTEM change	1 min	Maximal clot firmness in EXTEM after PCC or FFP
A5-FIBTEM change	1 min	clot amplitude at 5 min after clot initiation in FIBTEM after PCC or FFP
Postoperative bleeding	24 hour	chest tube drainage at postoperative 24 hour
Preparation time	1 min	from the start of cross-matching and thawing of FFP or unpacking of PCC in its storage area to the time of its delivery to patients in the operating room
success rate of the 1st coagulation management	10 min	incidence of achieving CT-EXTEM \< 80 sec after administering PCC or FFP as coagulation management

Countries

South Korea

Contacts

CONTACTTae-Yop KIm, MD PhD

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

PRINCIPAL_INVESTIGATORTae-Yop Kim, MD PhD

Konkuk University Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026