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

• Sponsor: Konkuk University Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06144099
• Collaborator: (none)
• Enrollment: 154
• Arms: 2
• Anticipated Duration (Months): 13

Study Details

Study Description

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 non-cardiac surgery.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Spine, Open; Hip Osteoarthritis; Knee Disease	Biological: fresh frozen plasma; Biological: prothrombin complex concentrate	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 154 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Prothrombin Complex Concentrate and Fresh Frozen Plasma in Viscoelastic Test-based Goal-directed Bleeding Management in Non-Cardiac Surgery
• Anticipated Study Start Date: Mar 1, 2024
• Anticipated Primary Completion Date: Apr 1, 2025
• Anticipated Study Completion Date: Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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; transfusion of 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; prothrombin complex concentrate administration

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Red Blood Cell amount [1 hour]

   Red Blood Cell transfusion amount during surgery

2. FFP amount [1 hour]

   FFP transfusion amount during surgery

3. Platelet amount [1 hour]

   Platelet transfusion amount during surgery

4. r-time [10 min]

   CK r-time after PCC or FFP

5. CRT-MA [10 min]

   CRT-MA after PCC or FFP

6. CFF-MA [10 min]

   CFF-MA after PCC or FFP

7. Bleeding [6 hour]

   Postoperative bleeding amount

8. oxygenation profile [1 hour]

   PaO2/FiO2 ratio

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• oral anticoagulants, warfarin

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Konkuk University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tae-Yop Kim, MD PhD, Professor of Anesthesiology, Konkuk University Medical Center
• ClinicalTrials.gov Identifier: NCT06144099
• Other Study ID Numbers: HC22195220002002
• First Posted: Nov 22, 2023
• Last Update Posted: Nov 22, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoarthritis, Hip; Thrombin

Study Results

No Results Posted as of Nov 22, 2023