- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03756948
Viscoelastic Tests-Guided Therapy In Liver Transplantation (VETLT)
Association Between Viscoelastic Tests-Guided Therapy With Synthetic Factor Concentrates And Allogenic Blood Transfusion In Liver Transplantation: A Before-After Study
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Usual Care (Before)
No Thromboelastometry No Synthetic Factor Concentrates Usual Care
|
Treatment of Coagulation Disorders Using Standard Coagulation Tests and Blood Components
|
Eksperimentell: Thromboelastometry-Guided Therapy (After)
Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates
|
Thromboelastometry-Guided Treatment of Coagulation Disorders Using Synthetic Factor Concentrates
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Need of Any Blood Products Transfusion
Tidsramme: 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.
|
48 Hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Use of Synthetic Factor Concentrates or Antifibrinolytic
Tidsramme: 48 Hours
|
Any use of synthetic factor concentrates or antifibrinolytic
|
48 Hours
|
Clinical Complications Related to the Procedure
Tidsramme: 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
|
Third days or until hospital discharge, whichever occurs first
|
Duration of Mechanical Ventilation
Tidsramme: Third days or until hospital discharge, whichever occurs first
|
Duration of mechanical ventilation in the post-operative period
|
Third days or until hospital discharge, whichever occurs first
|
ICU Length of Stay
Tidsramme: Third days or until ICU discharge, whichever occurs first
|
Duration of stay in the intensive care unit
|
Third days or until ICU discharge, whichever occurs first
|
Hospital Length of Stay
Tidsramme: Third days or until hospital discharge, whichever occurs first
|
Duration of stay in the hospital
|
Third days or until hospital discharge, whichever occurs first
|
In-Hospital Mortality
Tidsramme: Third days or until hospital discharge, whichever occurs first
|
Any death during hospitalization
|
Third days or until hospital discharge, whichever occurs first
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Ary Serpa Neto, MD, MSc, PhD, Physician and Researcher
- Studieleder: Raffael PC Zamper, MD, Raffael
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005 Apr;27(2):81-90. doi: 10.1111/j.1365-2257.2005.00681.x.
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VETLT
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