Risk factors for adverse cardiovascular events in liver transplantation
| ISRCTN | ISRCTN16660149 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16660149 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Klinička bolnica Merkur |
| Funder | Investigator initiated and funded |
- Submission date
- 04/02/2025
- Registration date
- 06/02/2025
- Last edited
- 06/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Liver cirrhosis is a terminal and irreversible stage of chronic hepatic disease. The etiology is various and includes alcohol, infections, carcinoma, medicaments and toxins, immune disease, cholestasis, metabolic causes, sarcoidosis etc. Therapy in end-stage liver disease is liver transplantation. A cadaveric orthotopic transplantation liver graft is a liver transplant where the donor organ (the graft) is taken from a deceased person (cadaver) and placed in the recipient's body in the same anatomical position as their native liver, replacing it completely. The donor and recipient's factors influence the transplantation procedure and its outcome, affecting post-transplant morbidity and mortality. Liver transplantation poses a high risk for cardiovascular complications and cardiac death. It can reverse certain pathologic states induced by hepatic disease but it can also lead to acute decompensation and cardiac death. Current studies show different incidences of cardiovascular adverse events during and after liver transplantation, without connecting donor-recipient traits to these events. This study aims to find the incidence of adverse cardiovascular events during orthotopic liver transplantation and during early posttransplant time and to establish which factors, donor and recipient, contribute to these adverse events. Furthermore, the study will create a simple grading scale that allows us to predict the incidence of severe cardiovascular adverse events in this vulnerable group of patients.
Who can participate?
All patients aged 18 years old and over who were admitted to University Hospital Merkur, Zagreb, Croatia for liver transplants between 2013 and 2015
What does the study involve?
The medical records of patients who are admitted for liver transplantation are reviewed, including their charts during and after surgery. Information about the donors is obtained from Eurotransplant donor reports. Scoring systems will be used to model the study outcomes.
What are the possible benefits and risks of participating?
The overall benefit of the study is for further patients who will be undergoing liver transplantation in future. Since this is an observational, non-intervention retrospective chart review study, there is no risk for participants.
Where is the study run from?
University Hospital Merkur (Klinička bolnica Merkur)
When is the study starting and how long is it expected to run for?
January 2013 to July 2016
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Nataša Višković Filipčić, MD., natasa.viskovic-filipcic@agram-bolnica.hr, natashav7@gmail.com
Contact information
Public, Scientific, Principal investigator
Školska 25
Velika Mlaka
10408
Croatia
 ORCID ID |
0009-0009-5804-3912 |
|---|---|
| Phone | +385 0913355998 |
| natasa.viskovic-filipcic@agram-bolnica.hr |
Public, Scientific, Principal investigator
Školska 25
Velika Mlaka
10408
Croatia
| Phone | +385 0913355998 |
|---|---|
| natashav7@gmail.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-center 3-year observational study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Risk factors associated with adverse cardiovascular events during orthotopic liver transplantation and during early posttransplant time |
| Study acronym | ACV-OLT |
| Study objectives | The incidence of adverse cardiovascular events during orthotopic liver transplantation and early posttransplant time is less than 5%. |
| Ethics approval(s) |
Approved 01/12/2014, Ethics Committee of University Hospital Merkur (Zajčeva 19, Zagreb, 10000, Croatia; +385 1 2353 801; eticko.povjerenstvo@kb-merkur.hr), ref: 0311-13652 |
| Health condition(s) or problem(s) studied | Adverse cardiovascular events in patients eligible for liver transplantation during the procedure itself and early posttransplant time |
| Intervention | Medical records of patients admitted for liver transplantation and their intraoperative and postoperative charts are examined. Donor data are acquired from Eurotransplant donor reports. Any subsequent scores are calculated according to official scoring systems ( MELD, DRI). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) | To establish the incidence of adverse cardiovascular events in a group of patients with liver transplantation during the transplant procedure and early posttransplant time (30 days) measured using data collected from patient medical records at one time point |
| Key secondary outcome measure(s) | The following secondary outcome measures are evaluated measured using data collected from patient medical records at one time point: 1. Donor and recipient characteristics in a subgroup of patients with severe adverse cardiovascular events 2. The risk of adverse cardiovascular complications in the subgroup of patients with severe adverse cardiovascular events defined using a simple grading scale 3. To create a simple scale based on donor and recipient characteristics, used for risk assessment |
| Completion date | 10/07/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 205 |
| Total final enrolment | 291 |
| Key inclusion criteria | 1. Patients admitted and undergoing liver transplantation in UH Merkur, Zagreb, Croatia 2. 18 years of age and older |
| Key exclusion criteria | 1. Age less than 18 years 2. Liver re-transplantation 3. Acute liver failure 4. Living donor liver transplantation 5. Multiorgan transplantation |
| Date of first enrolment | 10/08/2015 |
| Date of final enrolment | 10/07/2016 |
Locations
Countries of recruitment
- Croatia
Study participating centre
Zagreb
10000
Croatia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The dataset generated and/or analysed during the current study are not expected to be made available due to transplant laws and regulations |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/02/2025: Study's existence confirmed by the Ethics Committee of University Hospital Merkur.
