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

NCT ID: NCT06144125

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Valve Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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fresh frozen plasma

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

Group Type ACTIVE_COMPARATOR

fresh frozen plasma

Intervention Type BIOLOGICAL

transfusion of fresh frozen plasma

prothrombin complex concentrate

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

Group Type EXPERIMENTAL

prothrombin complex concentrate

Intervention Type BIOLOGICAL

prothrombin complex concentrate administration

Interventions

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fresh frozen plasma

transfusion of fresh frozen plasma

Intervention Type BIOLOGICAL

prothrombin complex concentrate

prothrombin complex concentrate administration

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* patients undergoing cardiac surgery

Exclusion Criteria

* thrombocytopenia
* oral anti-coagulant
* anti platelet agents
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Konkuk University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Tae-Yop Kim, MD PhD

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tae-Yop Kim, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Konkuk University Medical Center

Central Contacts

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Tae-Yop KIm, MD PhD

Role: CONTACT

[email protected]
+82-10-8811-6942

Other Identifiers

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HC22195220002004

Identifier Type: -

Identifier Source: org_study_id