Clinical trial · Interventional
Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Non-cardiac Surgery
Prothrombin Complex Concentrate and Fresh Frozen Plasma in Viscoelastic Test-based Goal-directed Bleeding Management in Non-Cardiac Surgery
NCT06144099CI-TRIAL-00072664unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hip Osteoarthritis | — | UNRESOLVED | — |
| Knee Disease | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Spine, Open | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fresh frozen plasma | Biological | — | UNRESOLVED |
| prothrombin complex concentrate | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- fresh frozen plasma
- description
- according to the Thromboelastography (TEG) test, CK r-time prolongation, fresh frozen plasma transfusion (FFP) is performed
- interventionNames
- Biological: fresh frozen plasma
- type
- EXPERIMENTAL
- label
- prothrombin complex concentrate
- description
- according to the Thromboelastography (TEG) test, CK r-time prolongation,prothrombin complex concentrate (PCC) administration
- interventionNames
- Biological: prothrombin complex concentrate
Primary outcomes (1)
- measure
- duration from the time diagnosing r-time prolongation to the time achieving bleeding control
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.