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Trial Title:
Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Non-cardiac Surgery
NCT ID:
NCT06144099
Condition:
Prostate Cancer
Spine, Open
Hip Osteoarthritis
Knee Disease
Conditions: Official terms:
Osteoarthritis, Hip
Spinal Dysraphism
Thrombin
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Biological
Intervention name:
fresh frozen plasma
Description:
transfusion of fresh frozen plasma
Arm group label:
fresh frozen plasma
Intervention type:
Biological
Intervention name:
prothrombin complex concentrate
Description:
prothrombin complex concentrate administration
Arm group label:
prothrombin complex concentrate
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- patients undergoing spine surgery
- patients undergoing open radical prostatectomy
- patients undergoing hip arthroplasty
- patients undergoing knee arthroplasty
Exclusion Criteria:
- Patients taking oral anticoagulants,
- Patient taking recombinant factor VII a
- pregnancy
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
March 1, 2024
Completion date:
April 1, 2025
Lead sponsor:
Agency:
Konkuk University Medical Center
Agency class:
Other
Source:
Konkuk University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06144099