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BACKGROUND: Perioperative bleeding and transfusion are important causes of morbidity and mortality in patients undergoing liver transplantation. The aim of this study is to assess whether viscoelastic tests-guided therapy with the use of synthetic factor concentrates impact transfusion rates of hemocomponents in adult patients undergoing liver transplantation.
METHODS: This is an interventional before-after comparative study. Patients undergoing liver transplantation before the implementation of a protocol using thromboelastometry and synthetic factor concentrates were compared to patients after the implementation. Primary outcome was transfusion of any hemocomponents. Secondary outcomes included: transfusion of red blood cells (RBC), fresh frozen plasma (FFP), cryoprecipitate or platelets, clinical complications, length of stay and in-hospital mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care (Before) | Active Comparator | No Thromboelastometry No Synthetic Factor Concentrates Usual Care |
|
| Thromboelastometry-Guided Therapy (After) | Experimental | Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care | Other | Treatment of Coagulation Disorders Using Standard Coagulation Tests and Blood Components |
|
| Measure | Description | Time Frame |
|---|---|---|
| Need of Any Blood Products Transfusion | Collapsed composite of need of any transfusion of blood product during surgery and in the first 48 hours in the postoperative, including the need of RBC, FFP, cryoprecipitate and/or platelets. | 48 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Use of Synthetic Factor Concentrates or Antifibrinolytic | Any use of synthetic factor concentrates or antifibrinolytic | 48 Hours |
| Clinical Complications Related to the Procedure | Defined as: 1) Upper digestive hemorrhage; 2) Arterial thrombosis; 3) Infection; and/or 4) Any thromboembolic event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ary Serpa Neto, MD, MSc, PhD | Physician and Researcher | Principal Investigator |
| Raffael PC Zamper, MD | Raffael | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23478547 | Background | Rana A, Petrowsky H, Hong JC, Agopian VG, Kaldas FM, Farmer D, Yersiz H, Hiatt JR, Busuttil RW. Blood transfusion requirement during liver transplantation is an important risk factor for mortality. J Am Coll Surg. 2013 May;216(5):902-7. doi: 10.1016/j.jamcollsurg.2012.12.047. Epub 2013 Mar 9. | |
| 26819521 | Background |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D020141 | Hemostatic Disorders |
| D001778 | Blood Coagulation Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates | Other | Thromboelastometry-Guided Treatment of Coagulation Disorders Using Synthetic Factor Concentrates |
|
| Third days or until hospital discharge, whichever occurs first |
| Duration of Mechanical Ventilation | Duration of mechanical ventilation in the post-operative period | Third days or until hospital discharge, whichever occurs first |
| ICU Length of Stay | Duration of stay in the intensive care unit | Third days or until ICU discharge, whichever occurs first |
| Hospital Length of Stay | Duration of stay in the hospital | Third days or until hospital discharge, whichever occurs first |
| In-Hospital Mortality | Any death during hospitalization | Third days or until hospital discharge, whichever occurs first |
| Hartmann M, Szalai C, Saner FH. Hemostasis in liver transplantation: Pathophysiology, monitoring, and treatment. World J Gastroenterol. 2016 Jan 28;22(4):1541-50. doi: 10.3748/wjg.v22.i4.1541. |
| 15784122 | Background | Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005 Apr;27(2):81-90. doi: 10.1111/j.1365-2257.2005.00681.x. |
| 22914710 | Background | Weber CF, Gorlinger K, Meininger D, Herrmann E, Bingold T, Moritz A, Cohn LH, Zacharowski K. Point-of-care testing: a prospective, randomized clinical trial of efficacy in coagulopathic cardiac surgery patients. Anesthesiology. 2012 Sep;117(3):531-47. doi: 10.1097/ALN.0b013e318264c644. |
| 20832550 | Background | Wang SC, Shieh JF, Chang KY, Chu YC, Liu CS, Loong CC, Chan KH, Mandell S, Tsou MY. Thromboelastography-guided transfusion decreases intraoperative blood transfusion during orthotopic liver transplantation: randomized clinical trial. Transplant Proc. 2010 Sep;42(7):2590-3. doi: 10.1016/j.transproceed.2010.05.144. |
| 30579327 | Derived | Zamper RPC, Amorim TC, Queiroz VNF, Lira JDO, Costa LGV, Takaoka F, Juffermans NP, Neto AS. Association between viscoelastic tests-guided therapy with synthetic factor concentrates and allogenic blood transfusion in liver transplantation: a before-after study. BMC Anesthesiol. 2018 Dec 22;18(1):198. doi: 10.1186/s12871-018-0664-8. |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |