Blood Coagulation DisordersNCT02239991
Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant
A study testing Thromboelastometry in people with Blood Coagulation Disorders and Evidence of Liver Transplantation, run by Hospital Israelita Albert Einstein at 2 sites in Brazil.
Trial summary
A point-of-care bleeding management protocol based on global viscoelastic test (thromboelastometry) can change the amount of blood products used during orthotopic liver transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Coagulation Disorders, Evidence of Liver Transplantation, Liver Cirrhosis
- What is being tested?
- Thromboelastometry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesBrazil
- Study dates
- Sep 2014to Feb 2016
- 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
- all patients from the national list of liver transplant assigned to have their transplant in Hospital Israelita Albert Einstein who gave free and clarified consent term.
Who cannot join
- acute liver failure
- age under 18
- combined transplant
- re transplantation less than 30 days
- incomplete medical records, more than 20% of missing data.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 1 recruiting
- Active, not recruiting
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05652-000
- Recruiting
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05652-900
Luiz Henrique Ide Yamauchi, Physician, +551121513729, luizyamauchi@gmail.com
Luiz Henrique Ide Yamauchi, Physician
About this study
A point-of-care bleeding management protocol based on global viscoelastic test (thromboelastometry) can change the amount of blood products used during orthotopic liver transplant.
Read the detailed description
Patients with liver disease frequently acquire a complex disorder of hemostasis secondary to their disease.
The fundamental key to the management of coagulopathy of cirrhotic patient is the knowledge that hepatic dysfunction results in impairment of both pro-hemostatic factors as anti-hemostatic factors in a disproportionate manner which can lead to a clinical picture of both bleeding and thrombosis.
Routine tests of coagulation as prothrombin time (PT, INR) and activated partial thromboplastin time (APTT) although prolonged in cirrhotic patients cannot predict bleeding.
Global viscoelastic test of whole blood (TEG / ROTEM) produce a dynamic composite image of the entire coagulation process and have the potential to provide clinically relevant information in patients with liver disease allowing rational use of blood products during liver transplantation.
- Being tested
- Thromboelastometry
- Keywords
- Point of care, perioperative hemostasis, thromboelastometry, bleeding risk, end-stage liver disease, hepatic coagulopathy, whole blood coagulation
- Medical subject headings
- Blood Coagulation Disorders, Liver Cirrhosis, End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThromboelastometryProcedure or surgery
Also called point of care bleeding management, ROTEM, viscoelastic test
Group of cirrhotic bleeding patients that are treated with a bed side, point of care protocol based on thromboelastometry to guide transfusion and manage coagulopathy
| Study group | Role | What they receive |
|---|---|---|
| Historical control | No intervention | Group of patients that had their coagulopathy secondary to the liver transplant treated based on conventional laboratory tests. Before the implementation of thromboelastometry. |
| Intervention | Experimental | Group of cirrhotic bleeding patients that are treated with a bed side, point of care protocol based on thromboelastometry to guide transfusion and manage coagulopathy Receives: Procedure: Thromboelastometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Units of packed red blood cells (PRBCs)
A prospective cohort study based on a point-of care protocol to monitor and manage the coagulopathy based on rotational thromboelastometry (ROTEM) in liver transplant with a historical control. Fifty patients will be managed by ROTEM protocol and will be compared with an equal number of historical controls treated according to the traditional protocol based on clinical and laboratory tests. The aim of this prospective study is to show a reduction in 20% of PRBCs transfusion during liver transplant.
Measured: intraoperative
Secondary outcomes (5)
mortality
All patients in interventional group will be followed for a period of 30 days.
Measured: 30 days
Sepsis
Sepsis is defined as the presence (probable or documented) of infection together with systemic manifestations of infection. All patients in interventional group will be followed for a period of 30 days.
Measured: During intensive care unit
Acute respiratory distress syndrome
A chest X-ray will be done in all patients and will be followed for a period of 30 days. A chest X-ray can reveal which parts of your lungs have fluid in them
Measured: During intensive care unit
Mechanical ventilation
All patients in interventional group will be followed for a period of 30 days and will be noted the number of days under mechanical ventilation.
Measured: During intensive care unit
Intensive care unit
Length of intensive care unit stay
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Blood Coagulation DisordersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Henrique Ide Yamauchi, Hospital Israelita Albert Einstein
- Investigators
- Luiz Henrique Ide Yamauchi, Physician, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239991
- Sponsor's protocol ID
- 1986-14
- Status last verified
- Sep 2014
- First submitted
- 3 Sep 2014
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
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 23478547Maxwell MJ, Wilson MJA. Complications of blood transfusion. Continuing Education in Anaesthesia. Crit Care Pain 2006; 6: 225-229
Massicotte L, Sassine MP, Lenis S, Roy A. Transfusion predictors in liver transplant. Anesth Analg. 2004 May;98(5):1245-51, table of contents. doi: 10.1213/01.ane.0000111184.21278.07.
PubMed 15105195Liu LL, Niemann CU. Intraoperative management of liver transplant patients. Transplant Rev (Orlando). 2011 Jul;25(3):124-9. doi: 10.1016/j.trre.2010.10.006. Epub 2011 Apr 21.
PubMed 21514137Ozier Y, Pessione F, Samain E, Courtois F; French Study Group on Blood Transfusion in Liver Transplantation. Institutional variability in transfusion practice for liver transplantation. Anesth Analg. 2003 Sep;97(3):671-679. doi: 10.1213/01.ANE.0000073354.38695.7C.
PubMed 12933381de Boer MT, Christensen MC, Asmussen M, van der Hilst CS, Hendriks HG, Slooff MJ, Porte RJ. The impact of intraoperative transfusion of platelets and red blood cells on survival after liver transplantation. Anesth Analg. 2008 Jan;106(1):32-44, table of contents. doi: 10.1213/01.ane.0000289638.26666.ed.
PubMed 18165548Liu S, Fan J, Wang X, Gong Z, Wang S, Huang L, Xing T, Li T, Peng Z, Sun X. Intraoperative cryoprecipitate transfusion and its association with the incidence of biliary complications after liver transplantation--a retrospective cohort study. PLoS One. 2013 May 10;8(5):e60727. doi: 10.1371/journal.pone.0060727. Print 2013.
PubMed 23675406Ramos E, Dalmau A, Sabate A, Lama C, Llado L, Figueras J, Jaurrieta E. Intraoperative red blood cell transfusion in liver transplantation: influence on patient outcome, prediction of requirements, and measures to reduce them. Liver Transpl. 2003 Dec;9(12):1320-7. doi: 10.1016/jlts.2003.50204.
PubMed 14625833Cacciarelli TV, Keeffe EB, Moore DH, Burns W, Busque S, Concepcion W, So SK, Esquivel CO. Effect of intraoperative blood transfusion on patient outcome in hepatic transplantation. Arch Surg. 1999 Jan;134(1):25-9. doi: 10.1001/archsurg.134.1.25.
PubMed 9927126Goodnough LT, Brecher ME, Kanter MH, AuBuchon JP. Transfusion medicine. First of two parts--blood transfusion. N Engl J Med. 1999 Feb 11;340(6):438-47. doi: 10.1056/NEJM199902113400606. No abstract available.
PubMed 9971869Goodnough LT, Brecher ME, Kanter MH, AuBuchon JP. Transfusion medicine. Second of two parts--blood conservation. N Engl J Med. 1999 Feb 18;340(7):525-33. doi: 10.1056/NEJM199902183400706. No abstract available.
PubMed 10021474Spahn DR, Casutt M. Eliminating blood transfusions: new aspects and perspectives. Anesthesiology. 2000 Jul;93(1):242-55. doi: 10.1097/00000542-200007000-00035. No abstract available.
PubMed 10861168Weber 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 22914710Davenport R, Khan S. Management of major trauma haemorrhage: treatment priorities and controversies. Br J Haematol. 2011 Dec;155(5):537-48. doi: 10.1111/j.1365-2141.2011.08885.x. Epub 2011 Oct 21.
PubMed 22017416Saner FH, Gieseler RK, Akiz H, Canbay A, Gorlinger K. Delicate balance of bleeding and thrombosis in end-stage liver disease and liver transplantation. Digestion. 2013;88(3):135-44. doi: 10.1159/000354400. Epub 2013 Sep 5.
PubMed 24008288
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant
- ClinicalTrials.gov ID
- NCT02239991
- Acronym / sponsor ID
- 1986-14
- Keywords
- Point of care, perioperative hemostasis, thromboelastometry, bleeding risk, end-stage liver disease, hepatic coagulopathy, whole blood coagulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 15 Sep 2014 (estimated)
- 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.
A point-of-care bleeding management protocol based on global viscoelastic test (thromboelastometry) can change the amount of blood products used during orthotopic liver transplant.
Detailed description
Patients with liver disease frequently acquire a complex disorder of hemostasis secondary to their disease.
The fundamental key to the management of coagulopathy of cirrhotic patient is the knowledge that hepatic dysfunction results in impairment of both pro-hemostatic factors as anti-hemostatic factors in a disproportionate manner which can lead to a clinical picture of both bleeding and thrombosis.
Routine tests of coagulation as prothrombin time (PT, INR) and activated partial thromboplastin time (APTT) although prolonged in cirrhotic patients cannot predict bleeding.
Global viscoelastic test of whole blood (TEG / ROTEM) produce a dynamic composite image of the entire coagulation process and have the potential to provide clinically relevant information in patients with liver disease allowing rational use of blood products during liver transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Historical control | No intervention | –Group of patients that had their coagulopathy secondary to the liver transplant treated based on conventional laboratory tests. Before the implementation of thromboelastometry. |
| Intervention | Experimental | Procedure: ThromboelastometryGroup of cirrhotic bleeding patients that are treated with a bed side, point of care protocol based on thromboelastometry to guide transfusion and manage coagulopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients from the national list of liver transplant assigned to have their transplant in Hospital Israelita Albert Einstein who gave free and clarified consent term.
Key exclusion criteria (5 listed)
- acute liver failure
- age under 18
- combined transplant
- re transplantation less than 30 days
- incomplete medical records, more than 20% of missing data.
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 |
|---|---|---|
| ThromboelastometryAlso: point of care bleeding management, ROTEM, viscoelastic testGroup of cirrhotic bleeding patients that are treated with a bed side, point of care protocol based on thromboelastometry to guide transfusion and manage coagulopathy | Procedure or surgery | Intervention |
Primary outcome
Units of packed red blood cells (PRBCs)
Time frame: intraoperative
A prospective cohort study based on a point-of care protocol to monitor and manage the coagulopathy based on rotational thromboelastometry (ROTEM) in liver transplant with a historical control. Fifty patients will be managed by ROTEM protocol and will be compared with an equal number of historical controls treated according to the traditional protocol based on clinical and laboratory tests. The aim of this prospective study is to show a reduction in 20% of PRBCs transfusion during liver transplant.
5 secondary outcomes
mortality
Time frame: 30 days
Sepsis
Time frame: During intensive care unit
Acute respiratory distress syndrome
Time frame: During intensive care unit
Mechanical ventilation
Time frame: During intensive care unit
Intensive care unit
Time frame: up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
- 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.
- BackgroundMaxwell MJ, Wilson MJA. Complications of blood transfusion. Continuing Education in Anaesthesia. Crit Care Pain 2006; 6: 225-229
- Background: PubMed 15105195Massicotte L, Sassine MP, Lenis S, Roy A. Transfusion predictors in liver transplant. Anesth Analg. 2004 May;98(5):1245-51, table of contents. doi: 10.1213/01.ane.0000111184.21278.07.
- Background: PubMed 21514137Liu LL, Niemann CU. Intraoperative management of liver transplant patients. Transplant Rev (Orlando). 2011 Jul;25(3):124-9. doi: 10.1016/j.trre.2010.10.006. Epub 2011 Apr 21.
- Background: PubMed 12933381Ozier Y, Pessione F, Samain E, Courtois F; French Study Group on Blood Transfusion in Liver Transplantation. Institutional variability in transfusion practice for liver transplantation. Anesth Analg. 2003 Sep;97(3):671-679. doi: 10.1213/01.ANE.0000073354.38695.7C.
- Background: PubMed 18165548de Boer MT, Christensen MC, Asmussen M, van der Hilst CS, Hendriks HG, Slooff MJ, Porte RJ. The impact of intraoperative transfusion of platelets and red blood cells on survival after liver transplantation. Anesth Analg. 2008 Jan;106(1):32-44, table of contents. doi: 10.1213/01.ane.0000289638.26666.ed.
- Background: PubMed 23675406Liu S, Fan J, Wang X, Gong Z, Wang S, Huang L, Xing T, Li T, Peng Z, Sun X. Intraoperative cryoprecipitate transfusion and its association with the incidence of biliary complications after liver transplantation--a retrospective cohort study. PLoS One. 2013 May 10;8(5):e60727. doi: 10.1371/journal.pone.0060727. Print 2013.
- Background: PubMed 14625833Ramos E, Dalmau A, Sabate A, Lama C, Llado L, Figueras J, Jaurrieta E. Intraoperative red blood cell transfusion in liver transplantation: influence on patient outcome, prediction of requirements, and measures to reduce them. Liver Transpl. 2003 Dec;9(12):1320-7. doi: 10.1016/jlts.2003.50204.
- Background: PubMed 9927126Cacciarelli TV, Keeffe EB, Moore DH, Burns W, Busque S, Concepcion W, So SK, Esquivel CO. Effect of intraoperative blood transfusion on patient outcome in hepatic transplantation. Arch Surg. 1999 Jan;134(1):25-9. doi: 10.1001/archsurg.134.1.25.
- Background: PubMed 9971869Goodnough LT, Brecher ME, Kanter MH, AuBuchon JP. Transfusion medicine. First of two parts--blood transfusion. N Engl J Med. 1999 Feb 11;340(6):438-47. doi: 10.1056/NEJM199902113400606. No abstract available.
- Background: PubMed 10021474Goodnough LT, Brecher ME, Kanter MH, AuBuchon JP. Transfusion medicine. Second of two parts--blood conservation. N Engl J Med. 1999 Feb 18;340(7):525-33. doi: 10.1056/NEJM199902183400706. No abstract available.
- Background: PubMed 10861168Spahn DR, Casutt M. Eliminating blood transfusions: new aspects and perspectives. Anesthesiology. 2000 Jul;93(1):242-55. doi: 10.1097/00000542-200007000-00035. No abstract available.
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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.
Luiz Henrique Ide Yamauchi, Physician principal investigator
Hospital Israelita Albert Einstein
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thromboelastometry in people with Blood Coagulation Disorders and Evidence of Liver Transplantation, run by Hospital Israelita Albert Einstein at 2 sites in Brazil.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luiz Henrique Ide Yamauchi, physician (+55112151-7806, luizyamauchi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Units of packed red blood cells (PRBCs) (time frame: intraoperative). 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 NCT02239991, which also lists 27 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 17 Sep 2014.