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Not yet recruitingNCT06144099Updated Jan 2, 2024

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

A Phase 4 interventional study of fresh frozen plasma and prothrombin complex concentrate in Prostate Cancer, Spine, Open and Hip Osteoarthritis, sponsored by Konkuk University Medical Center. Not yet recruiting. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-02.

Sponsored by Konkuk University Medical Center · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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 non-cardiac surgery.

02

Conditions studied

  • Prostate Cancer
  • Spine, Open
  • Hip Osteoarthritis
  • Knee Disease
03

In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

This study's planned enrollment of 154 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Konkuk University Medical Center is the lead sponsor of 95 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients undergoing spine surgery
  • patients undergoing open radical prostatectomy
  • patients undergoing hip arthroplasty
  • patients undergoing knee arthroplasty

Exclusion criteria

Exclusion Criteria:

  • Patients taking oral anticoagulants,
  • Patient taking recombinant factor VII a
  • pregnancy
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
154 participants (estimated)

Study arms

  • Active comparator
    fresh frozen plasma

    according to the Thromboelastography (TEG) test, CK r-time prolongation, fresh frozen plasma transfusion (FFP) is performed

    Biological: fresh frozen plasma

  • Experimental
    prothrombin complex concentrate

    according to the Thromboelastography (TEG) test, CK r-time prolongation,prothrombin complex concentrate (PCC) administration

    Biological: prothrombin complex concentrate

Interventions

06

What researchers measure

Primary outcomes

  1. duration from the time diagnosing r-time prolongation to the time achieving bleeding control

    Time frame: 1 min

Secondary outcomes

  1. Red Blood Cell amount

    Red Blood Cell transfusion amount during surgery

    Time frame: 1 hour

  2. FFP amount

    FFP transfusion amount during surgery

    Time frame: 1 hour

  3. Platelet amount

    Platelet transfusion amount during surgery

    Time frame: 1 hour

  4. r-time

    CK r-time after PCC or FFP

    Time frame: 10 min

  5. CRT-MA

    CRT-MA after PCC or FFP

    Time frame: 10 min

  6. CFF-MA

    CFF-MA after PCC or FFP

    Time frame: 10 min

  7. Bleeding

    Postoperative bleeding amount

    Time frame: 6 hour

  8. oxygenation profile

    PaO2/FiO2 ratio

    Time frame: 1 hour

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06144099
Lead sponsor
Konkuk University Medical Center
Responsible party
Tae-Yop Kim, MD PhD (Professor of Anesthesiology, Konkuk University Medical Center) — Principal investigator
First posted
Nov 22, 2023
Start date
Mar 1, 2024 (estimated)
Primary completion
Apr 1, 2025 (estimated)
Completion
Apr 1, 2025 (estimated)
Last update
Jan 2, 2024

Study contacts

Tae-Yop Kim, MD PhD
Contact
taeyop@gmail.com
+82-10-8811-6942

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Prothrombin complex concentrate

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