HemorrhageNCT02356068
Predictions of Bleeding During Liver Transplantation With Thromboelastometry
An observational study of Hemorrhage, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Patients with cirrhosis present complex coagulation defects. Conventional coagulation tests (INR, platelets count) can not predict bleeding or blood product requirements during liver transplantation. Thromboelastometry (TEM)analyser measures the viscoelastic of the whole blood coagulation generation and lysis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemorrhage
- What is being tested?
- ROTEM analysis
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to Feb 2018
- How long will I take part?
- 1 Week
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: every patient who had a liver transplantation
Who may be able to join
- every patient who had a liver transplantation
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
About this study
Official title: Thromboelastometry as a Tool to Predict Bleeding and Transfusion Requirement During Liver Transplantation
Patients with cirrhosis present complex coagulation defects. Conventional coagulation tests (INR, platelets count) can not predict bleeding or blood product requirements during liver transplantation. Thromboelastometry (TEM)analyser measures the viscoelastic of the whole blood coagulation generation and lysis. TEM results are available more rapidly than conventional tests and give additional information regarding coagulation strengh, platelet function, and fibrinolysis.
Read the detailed description
Historically, orthotopic liver transplantation (OLT) has been associated with major blood loss and the need for massive blood product transfusion . The cause of bleeding during OLT is multifactorial . The extensive surgical trauma plays a major role in the origin of bleeding. This bleeding can be accelerated by defects of the hemostatic system. Hemostatic defects can be divided into those present before the operation and those originating during the surgery. The latter can be classified according to the 3 main systems of hemostasis: coagulation, platelet function, and fibrinolysis. Hyperfibrinolysis is an important cause of non surgical bleeding during OLT .
A significant decrease in blood loss and blood product requirements has been observed during OLT over the past 10 years . This decrease can be explained by increase experience, improvements in surgical and anesthetic techniques, and a better understanding of the various hemostatic abnormalities encountered during OLT.
More than 10 years ago, Reyle-Hahn and Rossaint and Dupont et al stated that it is not necessary to correct coagulation defects before the anhepatic phase. More recently, some authors have a poor correlation between bleeding and the peripheral indices of coagulation in patients with chronic liver disease . These patients with cirrhosis are investigated by means of conventional tests for coagulation and primary hemostasis such as prothrombin time (INR), activated partial thromboplastin time (aPTT), platelet count, and skin bleeding time. Two important studies have raised serious questions about clinical use of INR in both measuring liver disease prognosis and in estimating bleeding risk thus calling into question many common and traditional clinical practices .
Now, it is cleat that conventional tests of coagulation (INR, platelet count, fibrinogen) are not able to predict blood product transfusion requirements and bleeding during liver transplantation.
A substantial body of evidence suggests that the use of blood products is associated with morbidity and mortality . Because 33% of liver recipients had acquired their liver disease through the transfusion of blood products , it is important to establish strategies aimed at decreasing blood losses and consequently the need for transfusion. The ability to predict intraoperative blood loss and transfusion requirements would be of great help to ensure adequate blood products and to enable appropriate therapy for patients at high risk of bleeding.
The ROTEM (TEM) thromboelastometry analyzer based on throboelastographic principles , measures the viscoelastic properties of whole blood coagulation generation and lysis. The instrument provides important global hemostatic information about the plasma-platelet-leucocyte interaction and clot tensile strength . TEM results are available more rapidly than those from laboratory-based conventional coagulation testing and also provide additional information regarding coagulation strength, platelet function, and fibrinolysis. Kang et al 39 using thromboelastogram (TEG) showed a decrease in red blood cells (RBC) use after the introduction of TEG monitoring.
ROTEM analysis includes plasmatic coagulation and fibrinolytic factors and inhibitors, as well as all circulating blood cells and provides clinically important information about quality of the final blood clot.
The aim of this observational study was to determine if ROTEM parameters were able to predict blood losses and transfusion of RBC during a liver transplantation.
- Conditions
- Hemorrhage
- Being tested
- ROTEM analysis
- Keywords
- liver transplantation, rotem, bleeding, transfusion
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROTEM analysisOther
3 blood samples for ROTEM analysis
| Study group | Role | What they receive |
|---|---|---|
| liver transplantation recepient | every patient who had a liver transplantation. 3 blood samples (2.7ml) for the ROTEM analysis Receives: Other: ROTEM analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
bleeding and transfusion
evaluation of bleeding and transfusion peroperatively and 24 hours post-op.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc Massicotte, Doctor, Principal investigator, CrCHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356068
- Sponsor's protocol ID
- there is no sponsor
- Status last verified
- Feb 2018
- First submitted
- 24 Jan 2015
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Carrier FM, Denault AY, Nozza A, Rioux-Masse B, Roy A, Massicotte L. Association between intraoperative rotational thromboelastometry or conventional coagulation tests and bleeding in liver transplantation: an observational exploratory study. Anaesth Crit Care Pain Med. 2020 Dec;39(6):765-770. doi: 10.1016/j.accpm.2020.07.018. Epub 2020 Oct 1.
PubMed 33011332
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboelastometry as a Tool to Predict Bleeding and Transfusion Requirement During Liver Transplantation
- ClinicalTrials.gov ID
- NCT02356068
- Acronym / sponsor ID
- there is no sponsor
- Conditions
- Hemorrhage
- Keywords
- liver transplantation, rotem, bleeding, transfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 5 Feb 2015 (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.
Patients with cirrhosis present complex coagulation defects. Conventional coagulation tests (INR, platelets count) can not predict bleeding or blood product requirements during liver transplantation. Thromboelastometry (TEM)analyser measures the viscoelastic of the whole blood coagulation generation and lysis. TEM results are available more rapidly than conventional tests and give additional information regarding coagulation strengh, platelet function, and fibrinolysis.
Detailed description
Historically, orthotopic liver transplantation (OLT) has been associated with major blood loss and the need for massive blood product transfusion . The cause of bleeding during OLT is multifactorial . The extensive surgical trauma plays a major role in the origin of bleeding. This bleeding can be accelerated by defects of the hemostatic system. Hemostatic defects can be divided into those present before the operation and those originating during the surgery. The latter can be classified according to the 3 main systems of hemostasis: coagulation, platelet function, and fibrinolysis. Hyperfibrinolysis is an important cause of non surgical bleeding during OLT .
A significant decrease in blood loss and blood product requirements has been observed during OLT over the past 10 years . This decrease can be explained by increase experience, improvements in surgical and anesthetic techniques, and a better understanding of the various hemostatic abnormalities encountered during OLT.
More than 10 years ago, Reyle-Hahn and Rossaint and Dupont et al stated that it is not necessary to correct coagulation defects before the anhepatic phase. More recently, some authors have a poor correlation between bleeding and the peripheral indices of coagulation in patients with chronic liver disease . These patients with cirrhosis are investigated by means of conventional tests for coagulation and primary hemostasis such as prothrombin time (INR), activated partial thromboplastin time (aPTT), platelet count, and skin bleeding time. Two important studies have raised serious questions about clinical use of INR in both measuring liver disease prognosis and in estimating bleeding risk thus calling into question many common and traditional clinical practices .
Now, it is cleat that conventional tests of coagulation (INR, platelet count, fibrinogen) are not able to predict blood product transfusion requirements and bleeding during liver transplantation.
A substantial body of evidence suggests that the use of blood products is associated with morbidity and mortality . Because 33% of liver recipients had acquired their liver disease through the transfusion of blood products , it is important to establish strategies aimed at decreasing blood losses and consequently the need for transfusion. The ability to predict intraoperative blood loss and transfusion requirements would be of great help to ensure adequate blood products and to enable appropriate therapy for patients at high risk of bleeding.
The ROTEM (TEM) thromboelastometry analyzer based on throboelastographic principles , measures the viscoelastic properties of whole blood coagulation generation and lysis. The instrument provides important global hemostatic information about the plasma-platelet-leucocyte interaction and clot tensile strength . TEM results are available more rapidly than those from laboratory-based conventional coagulation testing and also provide additional information regarding coagulation strength, platelet function, and fibrinolysis. Kang et al 39 using thromboelastogram (TEG) showed a decrease in red blood cells (RBC) use after the introduction of TEG monitoring.
ROTEM analysis includes plasmatic coagulation and fibrinolytic factors and inhibitors, as well as all circulating blood cells and provides clinically important information about quality of the final blood clot.
The aim of this observational study was to determine if ROTEM parameters were able to predict blood losses and transfusion of RBC during a liver transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liver transplantation recepient | – | Other: ROTEM analysisevery patient who had a liver transplantation. 3 blood samples (2.7ml) for the ROTEM analysis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- every patient who had a liver transplantation
Key inclusion criteria (1 listed)
- every patient who had a liver transplantation
Key exclusion criteria (1 listed)
- no
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 |
|---|---|---|
| ROTEM analysis3 blood samples for ROTEM analysis | Other | liver transplantation recepient |
Primary outcome
bleeding and transfusion
Time frame: 24 hours
evaluation of bleeding and transfusion peroperatively and 24 hours post-op.
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 24 Jul 2020.
- Derived from this study: PubMed 33011332Carrier FM, Denault AY, Nozza A, Rioux-Masse B, Roy A, Massicotte L. Association between intraoperative rotational thromboelastometry or conventional coagulation tests and bleeding in liver transplantation: an observational exploratory study. Anaesth Crit Care Pain Med. 2020 Dec;39(6):765-770. doi: 10.1016/j.accpm.2020.07.018. Epub 2020 Oct 1.
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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.
Luc Massicotte, Doctor principal investigator
CrCHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 1 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 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
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?
bleeding and transfusion (time frame: 24 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 NCT02356068, which also lists 1 linked publication.
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 24 Jul 2020.