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| Name | Class |
|---|---|
| Samsung Medical Center | OTHER |
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We compared the time consumed for goal-directed management of hypofibrinogemia using two strategies during liver transplant (LT) surgery: a conventional cryoprecipitate-based strategy versus a lyophilized fibrinogen concentrate-based strategy
The primary outcome is an inter-group comparison of treatment time (T-time, the duration from ordering cryoprecipitate or FC to completing its administration). The secondary measures include comparisons of perioperative bleeding, blood transfusion, coagulation profiles, reoperation, thromboembolic complications, mortality, oxygenation profiles, fibrinolysis phenotypes, and costs for bleeding management and length of hospital stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cryoprecipitate | Active Comparator | If serum-fibrinogen < 100 mg/dl or CFF-MA < 15 mm in thromboelastography (TEG), cryoprecipitate is administered |
|
| fibirnogen concentrate | Experimental | If serum-fibrinogen < 80 mg/dl or CFF-MA < 15 mm in thromboelastography (TEG), fibrinogen concentrate is administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fresh frozen plasma | Biological | transfusion of fresh frozen plasma |
| |
| Measure | Description | Time Frame |
|---|---|---|
| intergroup difference in the treatment time (T-time) | The treatment time (T-time): the duration from ordering cryoprecipitate or FC to completing its administration | 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42243996 | Derived | Bang YJ, Oh CS, Lee DK, Kang H, Kim KW, Kim H, Lee H, Kim TY, Kim GS. Fibrinogen concentrates versus cryoprecipitate for intraoperative hypofibrinogenemia in liver transplantation: study protocol for a randomized trial (FIBCRYO-LT trial). Trials. 2026 Jun 4;27(1):419. doi: 10.1186/s13063-026-09805-1. |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic 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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| 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 | 1 min |
| CRT-MA | CRT-MA after PCC or FFP | 1 min |
| CFF-MA | CFF-MA after PCC or FFP | 1 min |
| Bleeding | Postoperative bleeding amount | 6 hour |
| oxygenation profile | PaO2/FiO2 ratio | 1 hour |
| preparation time of cryoprecipitate or FC | time from the start of preparation (ABO-cross matching and thawing of cryoprecipitate or unpacking FC from its storage) to the delivery to patients in the operation theater | 1 min |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |