End Stage Liver DiseaseNCT02548130
Impact of MELD Score for 1000 Consecutive Liver Transplantations
An observational study of End Stage Liver Disease, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The goal of this observational study was to evaluate the impact of the adoption of the MELD system to prioritize patients on the waiting list for OLT on survival for 1000 consecutive liver transplantations. Survival was evaluated on the waiting list, one month, and one year after the transplantation. Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- End Stage Liver Disease
- What is being tested?
- MELD score
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jul 2015to 21 Jul 2019
- 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 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients for a liver transplantation
Who may be able to join
- Patients for a liver transplantation at the investigators' institution
Who cannot join
- None
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: Impact of the Introduction of the MELD Score to Prioritize the Waiting List on Survival, Blood Losses, And Transfusion Requirement for 1000 Consecutive Liver Transplantations, Observational Study
The goal of this observational study was to evaluate the impact of the adoption of the MELD system to prioritize patients on the waiting list for OLT on survival for 1000 consecutive liver transplantations. Survival was evaluated on the waiting list, one month, and one year after the transplantation. Another goal was to look at blood losses and transfusion requirement after the adoption of the MELD score. The hypothesis was the MELD system will ameliorate the survival rate on the waiting, but the post-OLT will be worse. Blood losses and transfusions could be worse with the MELD system.
Read the detailed description
IMPACT OF THE INTRODUCTION OF THE MELD SCORE TO PRIORITIZE THE WAITING LIST ON SURVIVAL, BLOOD LOSSES, AND TRANSFUSION REQUIREMENT FOR 1000 CONSECUTIVE LIVER TRANSPLANTATIONS, OBSERVATIONAL STUDY
INTRODUCTION
Orthotopic liver transplantation (OLT) has been classically associated with coagulation defects, blood loss, and the need for massive blood product transfusions .
Transfusion of blood products may contribute to morbidity and mortality. Ironically, one third of patients for OLT had acquired their diseases through transfusion of blood products.
The Child-Turcotte score was developed to predict complications for Porto-cave shunt surgery. This classification was used after to prioritize patients on the waiting for OLT. This classification which includes 3 subjective variables (nutrition, encephalopathy, ascites control) was improved by replacing nutrition by the international normalized ratio (INR) .
The Model of End-Stage Liver Disease (MELD) score was initially created to predict survival in patients with complications of portal hypertension undergoing elective placement of transjugular intrahepatic porto-systemic shunts (TIPS) . The MELD score may be an improvement of the Child-Turcotte-Pugh score as it includes 3 objectives laboratory test results: bilirubin (mg/dL), creatinine (mg/dL), and INR. More recently, MELD score has been validated both retrospectively and prospectively as an accurate predictor of mortality for patients who have chronic end-stage liver disease . After, the MELD system was adopted to reduce the ever-increasing mortality of patients on the waiting list for OLT.
The MELD score is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill). The MELD system is constantly being scrutinized and revised. So it's difficult to compare patients' MELD from different periods. Some authors have tried to use the MELD score to predict blood product requirements or survival after OLT . Although the MELD system reduces the mortality of patients on the waiting list, prioritizing the sickest patient raises a number of concerns. One of the main concerns is that the MELD may worsen the post-OLT outcomes resulting in futile transplantation. Many studies suggest that patients with high MELD score have worse post-OLT outcomes than patients with low MELD score.
The MELD system was adopted in the province of Quebec in July 2009. Before that the allocation system was: first priority was for intubated patients in an intensive care unit. The second priority was for patients in intensive care unit. The third priority was for hospitalized patients, and the final priority was for patients at home.
The goal of this observational study was to evaluate the impact of the adoption of the MELD system to prioritize patients on the waiting list for OLT on survival for 1000 consecutive liver transplantations. Survival was evaluated on the waiting list, one month, and one year after the transplantation. Another goal was to look at blood losses and transfusion requirement after the adoption of the MELD score. The hypothesis was the MELD system will ameliorate the survival rate on the waiting, but the post-OLT will be worse. Blood losses and transfusions could be worse with the MELD system.
METHODS
After approval of the Ethic committee of the Centre hospitalier de l'Université de Montréal (CHUM) (15.113) and registration on Clinical Trials.gov a non-experimental comparative study was conducted. 1000 consecutive liver transplantations were studied. Prioritization for the first 300 OLTs was as Quebec's allocation system at that time. The last 700 OLTs were prioritized according to the MELD system (since July 9th, 2009).
Surgery Protocol:
Eight hepatobiliary surgeons performed all the OLTs, and more than 25 anesthesiologists were involved throughout the study period. Monitoring was standardized in all patients, as was the anesthesia technique (arterial canula, pulmonary artery catheter, sufentanil, propofol, rocuronium, desflurane). In the absence of uncontrollable bleeding coagulation disorders were not corrected before or at the time of transplantation. No fresh frozen plasma (FFP), platelets or cryoprecipitate were given and a "wait-and-see" approach of rescue therapy was used instead of a prophylactic or preventive interventions. The triggering Hb level for RBC transfusion was set between 60 and 70 g/L. An effort was made to start a RBC transfusion after the blood loss was controlled. In the presence of diffuse oozing (any clinical evidence of coagulation) plasma (10-15 ml/kg) were transfused if the international normalized ratio (INR) value was higher than 1.5 to 2.0. Platelets were also transfused (5-10 units) if platelets count was lower than 30 X 109 pl/L, and cryoprecipitate (5 units) if fibrinogen was lower than 1.3-2.0 g/L. Aprotinin was administered in every case for the first 300 OLTs according to the Hammersmith protocol (37). The last 700 OLTs received tranexamic acid as antifibrinolytic according to the BART protocol.
Each anesthesiologist tried to lower the central venous pressure (CVP) before the anhepatic phase by one third using a restricting intravenous fluid infusion approach, phlebotomy without volume replacement or by a combination of both techniques. Phlebotomy consisted of withdrawing blood (from the introducer of the pulmonary artery catheter) at the beginning of the cas without any crystalloid or colloid volume replacement. Criteria for phlebotomy were: Hb concentration above 85 g/L, and a normal renal function. The quantity of blood withdrawn was guided by the patient's body mass (7-10 ml/kg). The phlebotomy was interrupted if the arterial blood pressure dropped by more than 20% of the baseline value in spite of vasopressor (phenylephrine or norepinephrine) administration. The CVP was slowly corrected after unclamping the inferior vena cava to avoid hepatic congestion. The previously withdrawn whole blood was returned to the patient at the end of surgery of before as needed. A cell saver (CS) was used for every case except for the initial 75 OLTs.
Two surgeons were involved in each procedure. Neither venovenous bypass nor piggyback technique was used except for very few cases where the piggyback technique was used. During dissection, bleeding was controlled almost exclusively by electrocautery and metallic clips.
All livers were harvested from brain dead donors and where ABO-Rh compatibles.
Statistical Analysis The MELD score was determined for each patient according to the equation: 0.957 X Loge creatinine mg/dL + 0.378 X Loge bilirubin mg/dL + 1.120 X Loge INR X 10 (14). The MELD score was adjusted according to the period (14). The data are expressed as mean ± standard deviation of the mean or as a percentage. Statistical analysis was performed using the Student'S T test, Welch T test as appropriate. The chi-square test served to compare percentages.
- Conditions
- End Stage Liver Disease
- Being tested
- MELD score
- Medical subject headings
- End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MELD scoreOther
introduction of MELD score
| Study group | Role | What they receive |
|---|---|---|
| Patients before MELD score | Recipients before the MELD score | |
| Patients after the MELD score | Recipients after the MELD score Receives: Other: MELD score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival;
Measured: one year
Secondary outcomes (2)
Bleeding
Measured: Per-operatively
transfusion of blood products
Measured: Per0operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study start29 Jul 2015
- Primary completion21 Jul 2019
- Study completion21 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Liver DiseaseStudies 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
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manon Choiniere, PhD, Principal investigator, CrCHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548130
- Sponsor's protocol ID
- Centre CHUM
- Status last verified
- Aug 2021
- First submitted
- 7 Sep 2015
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Introduction of the MELD Score to Prioritize the Waiting List on Survival, Blood Losses, And Transfusion Requirement for 1000 Consecutive Liver Transplantations, Observational Study
- ClinicalTrials.gov ID
- NCT02548130
- Acronym / sponsor ID
- Centre CHUM
- Conditions
- End Stage Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 29 Jul 2015 (actual)
- Primary completion
- 21 Jul 2019 (actual)
- Study completion
- 21 Jul 2019 (actual)
- First posted
- 14 Sep 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.
The goal of this observational study was to evaluate the impact of the adoption of the MELD system to prioritize patients on the waiting list for OLT on survival for 1000 consecutive liver transplantations. Survival was evaluated on the waiting list, one month, and one year after the transplantation. Another goal was to look at blood losses and transfusion requirement after the adoption of the MELD score. The hypothesis was the MELD system will ameliorate the survival rate on the waiting, but the post-OLT will be worse. Blood losses and transfusions could be worse with the MELD system.
Detailed description
IMPACT OF THE INTRODUCTION OF THE MELD SCORE TO PRIORITIZE THE WAITING LIST ON SURVIVAL, BLOOD LOSSES, AND TRANSFUSION REQUIREMENT FOR 1000 CONSECUTIVE LIVER TRANSPLANTATIONS, OBSERVATIONAL STUDY
INTRODUCTION
Orthotopic liver transplantation (OLT) has been classically associated with coagulation defects, blood loss, and the need for massive blood product transfusions .
Transfusion of blood products may contribute to morbidity and mortality. Ironically, one third of patients for OLT had acquired their diseases through transfusion of blood products.
The Child-Turcotte score was developed to predict complications for Porto-cave shunt surgery. This classification was used after to prioritize patients on the waiting for OLT. This classification which includes 3 subjective variables (nutrition, encephalopathy, ascites control) was improved by replacing nutrition by the international normalized ratio (INR) .
The Model of End-Stage Liver Disease (MELD) score was initially created to predict survival in patients with complications of portal hypertension undergoing elective placement of transjugular intrahepatic porto-systemic shunts (TIPS) . The MELD score may be an improvement of the Child-Turcotte-Pugh score as it includes 3 objectives laboratory test results: bilirubin (mg/dL), creatinine (mg/dL), and INR. More recently, MELD score has been validated both retrospectively and prospectively as an accurate predictor of mortality for patients who have chronic end-stage liver disease . After, the MELD system was adopted to reduce the ever-increasing mortality of patients on the waiting list for OLT.
The MELD score is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill). The MELD system is constantly being scrutinized and revised. So it's difficult to compare patients' MELD from different periods. Some authors have tried to use the MELD score to predict blood product requirements or survival after OLT . Although the MELD system reduces the mortality of patients on the waiting list, prioritizing the sickest patient raises a number of concerns. One of the main concerns is that the MELD may worsen the post-OLT outcomes resulting in futile transplantation. Many studies suggest that patients with high MELD score have worse post-OLT outcomes than patients with low MELD score.
The MELD system was adopted in the province of Quebec in July 2009. Before that the allocation system was: first priority was for intubated patients in an intensive care unit. The second priority was for patients in intensive care unit. The third priority was for hospitalized patients, and the final priority was for patients at home.
The goal of this observational study was to evaluate the impact of the adoption of the MELD system to prioritize patients on the waiting list for OLT on survival for 1000 consecutive liver transplantations. Survival was evaluated on the waiting list, one month, and one year after the transplantation. Another goal was to look at blood losses and transfusion requirement after the adoption of the MELD score. The hypothesis was the MELD system will ameliorate the survival rate on the waiting, but the post-OLT will be worse. Blood losses and transfusions could be worse with the MELD system.
METHODS
After approval of the Ethic committee of the Centre hospitalier de l'Université de Montréal (CHUM) (15.113) and registration on Clinical Trials.gov a non-experimental comparative study was conducted. 1000 consecutive liver transplantations were studied. Prioritization for the first 300 OLTs was as Quebec's allocation system at that time. The last 700 OLTs were prioritized according to the MELD system (since July 9th, 2009).
Surgery Protocol:
Eight hepatobiliary surgeons performed all the OLTs, and more than 25 anesthesiologists were involved throughout the study period. Monitoring was standardized in all patients, as was the anesthesia technique (arterial canula, pulmonary artery catheter, sufentanil, propofol, rocuronium, desflurane). In the absence of uncontrollable bleeding coagulation disorders were not corrected before or at the time of transplantation. No fresh frozen plasma (FFP), platelets or cryoprecipitate were given and a "wait-and-see" approach of rescue therapy was used instead of a prophylactic or preventive interventions. The triggering Hb level for RBC transfusion was set between 60 and 70 g/L. An effort was made to start a RBC transfusion after the blood loss was controlled. In the presence of diffuse oozing (any clinical evidence of coagulation) plasma (10-15 ml/kg) were transfused if the international normalized ratio (INR) value was higher than 1.5 to 2.0. Platelets were also transfused (5-10 units) if platelets count was lower than 30 X 109 pl/L, and cryoprecipitate (5 units) if fibrinogen was lower than 1.3-2.0 g/L. Aprotinin was administered in every case for the first 300 OLTs according to the Hammersmith protocol (37). The last 700 OLTs received tranexamic acid as antifibrinolytic according to the BART protocol.
Each anesthesiologist tried to lower the central venous pressure (CVP) before the anhepatic phase by one third using a restricting intravenous fluid infusion approach, phlebotomy without volume replacement or by a combination of both techniques. Phlebotomy consisted of withdrawing blood (from the introducer of the pulmonary artery catheter) at the beginning of the cas without any crystalloid or colloid volume replacement. Criteria for phlebotomy were: Hb concentration above 85 g/L, and a normal renal function. The quantity of blood withdrawn was guided by the patient's body mass (7-10 ml/kg). The phlebotomy was interrupted if the arterial blood pressure dropped by more than 20% of the baseline value in spite of vasopressor (phenylephrine or norepinephrine) administration. The CVP was slowly corrected after unclamping the inferior vena cava to avoid hepatic congestion. The previously withdrawn whole blood was returned to the patient at the end of surgery of before as needed. A cell saver (CS) was used for every case except for the initial 75 OLTs.
Two surgeons were involved in each procedure. Neither venovenous bypass nor piggyback technique was used except for very few cases where the piggyback technique was used. During dissection, bleeding was controlled almost exclusively by electrocautery and metallic clips.
All livers were harvested from brain dead donors and where ABO-Rh compatibles.
Statistical Analysis The MELD score was determined for each patient according to the equation: 0.957 X Loge creatinine mg/dL + 0.378 X Loge bilirubin mg/dL + 1.120 X Loge INR X 10 (14). The MELD score was adjusted according to the period (14). The data are expressed as mean ± standard deviation of the mean or as a percentage. Statistical analysis was performed using the Student'S T test, Welch T test as appropriate. The chi-square test served to compare percentages.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients before MELD score | – | –Recipients before the MELD score |
| Patients after the MELD score | – | Other: MELD scoreRecipients after the MELD score |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients for a liver transplantation
Key inclusion criteria (1 listed)
- Patients for a liver transplantation at the investigators' institution
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| MELD scoreintroduction of MELD score | Other | Patients after the MELD score |
Primary outcome
Survival;
Time frame: one year
2 secondary outcomes
Bleeding
Time frame: Per-operatively
transfusion of blood products
Time frame: Per0operatively
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 20 Aug 2021.
Related trials for End Stage Liver Disease
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
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.
Manon Choiniere, PhD 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 End Stage Liver Disease, 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 20 Aug 2021. 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?
Survival; (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2021.