Liver Transplant; ComplicationsVETLTNCT03756948
Viscoelastic Tests-Guided Therapy In Liver Transplantation
A study testing Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates in people with Liver Transplant; Complications and Bleeding, run by Hospital Israelita Albert Einstein.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant; Complications, Bleeding, Hemostatic Disorder
- What is being tested?
- Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2007to 1 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Deceased Donor Liver Transplantation
- Chronic Liver Disease
Who cannot join
- Acute Liver Failure
- Combined Transplantation
- Re-Transplantation is Less Than 30 Days After the First Transplant
About this study
Official title: 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.
- Being tested
- Usual Care, Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates
- Keywords
- Liver Transplantation, Blood Coagulation Disorders, Blood Transfusion, Hemostasis, Thromboelastometry
- Medical subject headings
- Hemorrhage, Hemostatic Disorders, Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Treatment of Coagulation Disorders Using Standard Coagulation Tests and Blood Components
Thromboelastometry-Guided Therapy with Synthetic Factor ConcentratesOther
Thromboelastometry-Guided Treatment of Coagulation Disorders Using Synthetic Factor Concentrates
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (Before) | Active comparator | No Thromboelastometry No Synthetic Factor Concentrates Usual Care Receives: Other: Usual Care |
| Thromboelastometry-Guided Therapy (After) | Experimental | Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates Receives: Other: Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 Hours
Secondary outcomes (6)
Use of Synthetic Factor Concentrates or Antifibrinolytic
Any use of synthetic factor concentrates or antifibrinolytic
Measured: 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
Measured: Third days or until hospital discharge, whichever occurs first
Duration of Mechanical Ventilation
Duration of mechanical ventilation in the post-operative period
Measured: Third days or until hospital discharge, whichever occurs first
ICU Length of Stay
Duration of stay in the intensive care unit
Measured: Third days or until ICU discharge, whichever occurs first
Hospital Length of Stay
Duration of stay in the hospital
Measured: Third days or until hospital discharge, whichever occurs first
In-Hospital Mortality
Any death during hospitalization
Measured: Third days or until hospital discharge, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start1 Jan 2007
- Primary completion30 Oct 2015
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ary Serpa Neto, MD, MSc, PhD, Principal investigator, Physician and ResearcherRaffael PC Zamper, MD, Study director, Raffael
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756948
- Sponsor's protocol ID
- VETLT
- Acronym
- VETLT
- Status last verified
- Nov 2018
- First submitted
- 16 Nov 2018
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 23478547Hartmann 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.
PubMed 26819521Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005 Apr;27(2):81-90. doi: 10.1111/j.1365-2257.2005.00681.x.
PubMed 15784122Weber 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.
PubMed 22914710Wang 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.
PubMed 20832550Zamper 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.
PubMed 30579327
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Viscoelastic Tests-Guided Therapy With Synthetic Factor Concentrates And Allogenic Blood Transfusion In Liver Transplantation: A Before-After Study
- ClinicalTrials.gov ID
- NCT03756948
- Acronym / sponsor ID
- VETLT / VETLT
- Keywords
- Liver Transplantation, Blood Coagulation Disorders, Blood Transfusion, Hemostasis, Thromboelastometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 30 Oct 2015 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care (Before) | Active comparator | Other: Usual CareNo Thromboelastometry No Synthetic Factor Concentrates Usual Care |
| Thromboelastometry-Guided Therapy (After) | Experimental | Other: Thromboelastometry-Guided Therapy with Synthetic Factor ConcentratesThromboelastometry-Guided Therapy with Synthetic Factor Concentrates |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Deceased Donor Liver Transplantation
- Chronic Liver Disease
Key exclusion criteria (3 listed)
- Acute Liver Failure
- Combined Transplantation
- Re-Transplantation is Less Than 30 Days After the First Transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareTreatment of Coagulation Disorders Using Standard Coagulation Tests and Blood Components | Other | Usual Care (Before) |
| Thromboelastometry-Guided Therapy with Synthetic Factor ConcentratesThromboelastometry-Guided Treatment of Coagulation Disorders Using Synthetic Factor Concentrates | Other | Thromboelastometry-Guided Therapy (After) |
Primary outcome
Need of Any Blood Products Transfusion
Time frame: 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.
6 secondary outcomes
Use of Synthetic Factor Concentrates or Antifibrinolytic
Time frame: 48 Hours
Clinical Complications Related to the Procedure
Time frame: Third days or until hospital discharge, whichever occurs first
Duration of Mechanical Ventilation
Time frame: Third days or until hospital discharge, whichever occurs first
ICU Length of Stay
Time frame: Third days or until ICU discharge, whichever occurs first
Hospital Length of Stay
Time frame: Third days or until hospital discharge, whichever occurs first
In-Hospital Mortality
Time frame: Third days or until hospital discharge, whichever occurs first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Background: PubMed 23478547Rana 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.
- Background: PubMed 26819521Hartmann 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.
- Background: PubMed 15784122Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005 Apr;27(2):81-90. doi: 10.1111/j.1365-2257.2005.00681.x.
- Background: PubMed 22914710Weber 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.
- Background: PubMed 20832550Wang 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.
- Derived from this study: PubMed 30579327Zamper 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ary Serpa Neto, MD, MSc, PhD principal investigator
Physician and Researcher
Raffael PC Zamper, MD study director
Raffael
Questions about this trial
What is this clinical trial studying?
A study testing Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates in people with Liver Transplant; Complications and Bleeding, run by Hospital Israelita Albert Einstein.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need of Any Blood Products Transfusion (time frame: 48 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03756948, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2018.