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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 non-cardiac surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fresh frozen plasma | Active Comparator | according to the Thromboelastography (TEG) test, CK r-time prolongation, fresh frozen plasma transfusion (FFP) is performed |
|
| prothrombin complex concentrate | Experimental | according to the Thromboelastography (TEG) test, CK r-time prolongation,prothrombin complex concentrate (PCC) administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fresh frozen plasma | Biological | transfusion of fresh frozen plasma |
| |
| Measure | Description | Time Frame |
|---|---|---|
| duration from the time diagnosing r-time prolongation to the time achieving bleeding control | 1 min |
| Measure | Description | Time Frame |
|---|---|---|
| Red Blood Cell amount | Red Blood Cell transfusion amount during surgery | 1 hour |
| FFP amount | FFP transfusion amount during surgery | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tae-Yop Kim, MD PhD | Contact | +82-10-8811-6942 | taeyop@gmail.com |
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| prothrombin complex concentrate |
| Biological |
prothrombin complex concentrate administration |
|
| Platelet amount | Platelet transfusion amount during surgery | 1 hour |
| r-time | CK r-time after PCC or FFP | 10 min |
| CRT-MA | CRT-MA after PCC or FFP | 10 min |
| CFF-MA | CFF-MA after PCC or FFP | 10 min |
| Bleeding | Postoperative bleeding amount | 6 hour |
| oxygenation profile | PaO2/FiO2 ratio | 1 hour |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D016135 | Spinal Dysraphism |
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009436 | Neural Tube Defects |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D005164 | Factor IX |
| ID | Term |
|---|---|
| D004792 | Enzyme Precursors |
| D045762 | Enzymes and Coenzymes |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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