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| Name | Class |
|---|---|
| Asan Medical Center | OTHER |
| Soonchunhyang University Hospital | OTHER |
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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 cardiac surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fresh frozen plasma | Active Comparator | according to the Rotational thromboelastometry (ROTEM) test, CT-EXTEM prolongation, fresh frozen plasma transfusion (FFP) 10-15 ml/kg is performed |
|
| prothrombin complex concentrate | Experimental | according to the Rotational thromboelastometry (ROTEM) test, CT-EXTEM prolongation, prothrombin complex concentrate (PCC) 10-15 IU/kg is administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fresh frozen plasma | Biological | transfusion of fresh frozen plasma |
| |
| Measure | Description | Time Frame |
|---|---|---|
| treatment time | duration from the time of diagnosing CT-EXTEM prolongation (ordering PCC or FFP) to the time achieving bleeding control (completing administration of PCC or FFP) | 1 min |
| Measure | Description | Time Frame |
|---|---|---|
| Red Blood Cell amount | Red Blood Cell transfusion amount during surgery | I hour |
| FFP amount | Red Blood Cell transfusion amount during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Thromboembolism complication | myocardial infarction, stroke, cerebral infarction, bowel ischemia | 24 hour |
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 |
| Name | Affiliation | Role |
|---|---|---|
| Tae-Yop Kim, MD PhD | Konkuk University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk University Medical Center | Recruiting | Seoul | Seoul | 05030 | South Korea |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D002836 | Hemophilia B |
| D013927 | Thrombosis |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
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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 |
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Patients are randomly divided into two groups (experimental vs control groups).
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| prothrombin complex concentrate |
| Biological |
prothrombin complex concentrate administration |
|
| 1 hour |
| Platelet amount | Platelet transfusion amount during surgery | 1 hour |
| cryoprecipiate amount | amount of cryoprecipitate transfusion | 1 hour |
| CT-EXTEM change | clotting time-EXTEM after PCC or FFP | 1 min |
| A5-EXTEM change | clot amplitude at 5 min after clot initiation in EXTEM after PCC or FFP | 1 min |
| MCF-EXTEM change | Maximal clot firmness in EXTEM after PCC or FFP | 1 min |
| A5-FIBTEM change | clot amplitude at 5 min after clot initiation in FIBTEM after PCC or FFP | 1 min |
| Postoperative bleeding | chest tube drainage at postoperative 24 hour | 24 hour |
| Preparation time | from the start of cross-matching and thawing of FFP or unpacking of PCC in its storage area to the time of its delivery to patients in the operating room | 1 min |
| success rate of the 1st coagulation management | incidence of achieving CT-EXTEM < 80 sec after administering PCC or FFP as coagulation management | 10 min |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |