Association Between Viscoelastic Tests-Guided Therapy With Synthetic Factor Concentrates And Allogenic Blood Transfusion In Liver Transplantation: A Before-After Study
| Registry | NCT03756948, acronym VETLT |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; non randomized, sequential, masking: none, treatment |
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| Enrollment | 237 (Actual) |
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| Sponsor | Hospital Israelita Albert Einstein (Other) |
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| Conditions | Liver Transplant; Complications, Bleeding, Hemostatic Disorder |
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| Interventions | Usual Care, Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates (Other) |
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| Dates | start 2007-01-01, primary completion 2015-10-30, completion 2018-01-01, first posted 2018-11-28, last updated 2018-11-28 |
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-Summary
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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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Usual Care (Before) | Active comparator | Other: Usual Care | No Thromboelastometry No Synthetic Factor Concentrates Usual Care |
| Thromboelastometry-Guided Therapy (After) | Experimental | Other: Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates | Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates |
- Usual Care (Other): Treatment of Coagulation Disorders Using Standard Coagulation Tests and Blood Components
- Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates (Other): Thromboelastometry-Guided Treatment of Coagulation Disorders Using Synthetic Factor Concentrates
+Outcome measures
Primary outcomes
- Need of Any Blood Products Transfusion [48 Hours]: 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.
Secondary outcomes
- Use of Synthetic Factor Concentrates or Antifibrinolytic [48 Hours]: Any use of synthetic factor concentrates or antifibrinolytic
- Clinical Complications Related to the Procedure [Third days or until hospital discharge, whichever occurs first]: Defined as: 1) Upper digestive hemorrhage; 2) Arterial thrombosis; 3) Infection; and/or 4) Any thromboembolic event
- Duration of Mechanical Ventilation [Third days or until hospital discharge, whichever occurs first]: Duration of mechanical ventilation in the post-operative period
- ICU Length of Stay [Third days or until ICU discharge, whichever occurs first]: Duration of stay in the intensive care unit
- Hospital Length of Stay [Third days or until hospital discharge, whichever occurs first]: Duration of stay in the hospital
- In-Hospital Mortality [Third days or until hospital discharge, whichever occurs first]: Any death during hospitalization
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* Deceased Donor Liver Transplantation
* Chronic Liver Disease
Exclusion Criteria:
* Acute Liver Failure
* Combined Transplantation
* Re-Transplantation is Less Than 30 Days After the First Transplant
+Publications
- 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. PMID 23478547
- 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. PMID 26819521
- Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005 Apr;27(2):81-90. doi: 10.1111/j.1365-2257.2005.00681.x. PMID 15784122
- 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. PMID 22914710
- 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. PMID 20832550
- Results publication: 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. PMID 30579327
+Investigators