Liver TransplantationPORTALNCT04472312
Portal Pressure Effects of Phlebotomy Combined to Vasopressin Use in Cirrhotic Patients Undergoing Liver Transplantation
An observational study of Liver Transplantation and Portal Hypertension, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Liver transplantation is the standard treatment for chronic advanced liver disease, whether or not associated with a primary liver tumor. The intraoperative bleeding and the need for blood transfusion, encountered in this major surgery are associated with increased morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, Portal Hypertension, Blood Transfusion
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 24 Aug 2020to 6 Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators aim to conduct a prospective observational, non-interventional study, respecting current practice. This study will take place at the Centre de recherche de l'Université de Montréal (CHUM) where there are approximately 70 to 80 liver transplants per year.
Who may be able to join
- Cirrhotic patients undergoing a liver transplantation
- 18 years and older
- Planned use of vasopressin during the surgery
Who cannot join
- Fulminant or sub-fulminant hepatitis without underlying chronic liver disease
- Anesthetic plan does not include the use of vasopressin (contraindication or not relevant according to the anesthesiologist)
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: Portal Pressure Effects of Phlebotomy Combined to Vasopressin Use in Cirrhotic Patients Undergoing Liver Transplantation: the PORTAL Study.
Liver transplantation is the standard treatment for chronic advanced liver disease, whether or not associated with a primary liver tumor. The intraoperative bleeding and the need for blood transfusion, encountered in this major surgery are associated with increased morbidity and mortality. However, this hemorrhagic risk has been drastically reduced in the last 20 years and liver transplants without the use of blood products are now possible. Indeed, improvements in medical and surgical techniques associated with a better understanding of the pathophysiology of the cirrhotic patient have enabled this advance. One of the targeted therapeutic strategies is the control of portal hypertension. Several treatments have been sought, such as the use of splanchnic vasoconstrictors (such as vasopressin) and hypovolemic phlebotomy. These techniques reduce portal pressure and seem to reduce intraoperative bleeding with, even, a protective effect on kidney function. Their single-use or their combination is currently used in certain centers of expertise in liver transplantation. However, the hemodynamic effects of the combination of these 2 treatments on portal pressure has never been demonstrated. In this study, the effect of vasopressin, combined with a hypovolemic phlebotomy, on portal pressure in cirrhotic patients undergoing liver transplantation will be evaluated.
Read the detailed description
METHODS
Objectives
The primary objective will be to measure the hemodynamic effects of vasopressin on portal pressure in cirrhotic patients who have had a hypovolemic phlebotomy during a liver transplant.
The secondary objectives will be to measure the effects of vasopressin on portal pressure in patients who have not had a phlebotomy and to compare this effect between patients who have or have not had a hypovolemic phlebotomy.
The tertiary objective will be to assess the effect of the variation in portal pressure under vasopressin, associated or not with a hypovolemic phlebotomy, on hemorrhagic clinical outcomes (intraoperative bleeding and blood transfusions).
- Medical subject headings
- Hypertension, Portal, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cirrhotic patients undergoing a liver transplantation | The investigators aim to conduct a prospective observational, non-interventional study including all cirrhotic patients undergoing a liver transplantation with a planned use of vasopressin during the surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Portal pressure measurement
The venous pressure in the liver will be measured by inserting a very fine needle in the portal vein. The needle will be connected to a pressure sensor and will be removed after the measurement. This measure will be performed at three different moments during the surgery; 1) as soon as possible after the incision; 2) 5 minutes after the end of the hypovolemic phlebotomy (if performed); 3) 10 minutes after the start of vasopressin infusion.
Measured: During the surgery (intraoperatively)
Secondary outcomes (4)
Intraoperative blood loss
During the liver transplantation, a cell salvage device (Cell Saver) will be set up in the operating room. As the surgery progresses, the blood lost by the patient will be collected using suctions. The volume of blood (mL) in the suctions will be measured at the end of the surgery, before the blood is cleaned and returned back to the patient.
Measured: At the end of the surgery
Packed red blood cell transfusion rates
Number of units of packed red blood cells transfused to participants will be recorded.
Measured: Intraoperatively and up to 24 hours following surgery
Rate of acute kidney injury (AKI) grade 2 or 3
The onset or worsening of acute postoperative grade 2 or 3 renal failure according to KDIGO-AKI criteria.
Measured: Assessed at 24 hours and 48 hours following surgery
Rate of new renal therapy replacement
Any need of new renal therapy replacement occurring during the hospital stay up to 7 days following surgery will be recorded.
Measured: Postoperative setting up to 7 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start24 Aug 2020
- Primary completion29 Jun 2022
- Study completion6 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies 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
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François-Martin Carrier, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472312
- Sponsor's protocol ID
- 20.121
- Acronym
- PORTAL
- Status last verified
- Jul 2022
- First submitted
- 9 Jul 2020
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portal Pressure Effects of Phlebotomy Combined to Vasopressin Use in Cirrhotic Patients Undergoing Liver Transplantation: the PORTAL Study.
- ClinicalTrials.gov ID
- NCT04472312
- Acronym / sponsor ID
- PORTAL / 20.121
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 29 Jun 2022 (actual)
- Study completion
- 6 Jul 2022 (actual)
- First posted
- 15 Jul 2020 (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.
Liver transplantation is the standard treatment for chronic advanced liver disease, whether or not associated with a primary liver tumor. The intraoperative bleeding and the need for blood transfusion, encountered in this major surgery are associated with increased morbidity and mortality. However, this hemorrhagic risk has been drastically reduced in the last 20 years and liver transplants without the use of blood products are now possible. Indeed, improvements in medical and surgical techniques associated with a better understanding of the pathophysiology of the cirrhotic patient have enabled this advance. One of the targeted therapeutic strategies is the control of portal hypertension. Several treatments have been sought, such as the use of splanchnic vasoconstrictors (such as vasopressin) and hypovolemic phlebotomy. These techniques reduce portal pressure and seem to reduce intraoperative bleeding with, even, a protective effect on kidney function. Their single-use or their combination is currently used in certain centers of expertise in liver transplantation. However, the hemodynamic effects of the combination of these 2 treatments on portal pressure has never been demonstrated. In this study, the effect of vasopressin, combined with a hypovolemic phlebotomy, on portal pressure in cirrhotic patients undergoing liver transplantation will be evaluated.
Detailed description
METHODS
Objectives
The primary objective will be to measure the hemodynamic effects of vasopressin on portal pressure in cirrhotic patients who have had a hypovolemic phlebotomy during a liver transplant.
The secondary objectives will be to measure the effects of vasopressin on portal pressure in patients who have not had a phlebotomy and to compare this effect between patients who have or have not had a hypovolemic phlebotomy.
The tertiary objective will be to assess the effect of the variation in portal pressure under vasopressin, associated or not with a hypovolemic phlebotomy, on hemorrhagic clinical outcomes (intraoperative bleeding and blood transfusions).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cirrhotic patients undergoing a liver transplantation | – | –The investigators aim to conduct a prospective observational, non-interventional study including all cirrhotic patients undergoing a liver transplantation with a planned use of vasopressin during the surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators aim to conduct a prospective observational, non-interventional study, respecting current practice. This study will take place at the Centre de recherche de l'Université de Montréal (CHUM) where there are approximately 70 to 80 liver transplants per year.
Key inclusion criteria (3 listed)
- Cirrhotic patients undergoing a liver transplantation
- 18 years and older
- Planned use of vasopressin during the surgery
Key exclusion criteria (2 listed)
- Fulminant or sub-fulminant hepatitis without underlying chronic liver disease
- Anesthetic plan does not include the use of vasopressin (contraindication or not relevant according to the anesthesiologist)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Portal pressure measurement
Time frame: During the surgery (intraoperatively)
The venous pressure in the liver will be measured by inserting a very fine needle in the portal vein. The needle will be connected to a pressure sensor and will be removed after the measurement. This measure will be performed at three different moments during the surgery; 1) as soon as possible after the incision; 2) 5 minutes after the end of the hypovolemic phlebotomy (if performed); 3) 10 minutes after the start of vasopressin infusion.
4 secondary outcomes
Intraoperative blood loss
Time frame: At the end of the surgery
Packed red blood cell transfusion rates
Time frame: Intraoperatively and up to 24 hours following surgery
Rate of acute kidney injury (AKI) grade 2 or 3
Time frame: Assessed at 24 hours and 48 hours following surgery
Rate of new renal therapy replacement
Time frame: Postoperative setting up to 7 days following surgery
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 22 Jul 2022.
- 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.
François-Martin Carrier, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
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 Liver Transplantation and Portal Hypertension, 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 3 inclusion and 2 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 22 Jul 2022. 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?
Portal pressure measurement (time frame: During the surgery (intraoperatively)). 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 22 Jul 2022.