Liver Transplantation and AntithrombinNCT04912193
Antithrombin III and Post-liver Transplantation Acute Kidney Injury
An observational study of Liver Transplantation and Antithrombin, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The reno-protective effect of Antithrombin III (ATIII) has been well-studied in various animal studies; however, little is known about the effect of ATIII on kidney function in patients undergoing liver transplantation (LT). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Liver Transplantation and Antithrombin
- What is being tested?
- Antithrombin III
- How many people
- 2,395 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Jan 2010to 31 Dec 2019
- How long will I take part?
- 1 Year
- 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 19 years and older
- All sexes
- Adult, Older adult
Study population: patients who underwent either living- or deceased-donor LT (LDLT, DDLT) from January 2010 to January 2018 in Asan Medical Center.
Who may be able to join
- patients who underwent either living- or deceased-donor LT (LDLT, DDLT) from January 2010 to January 2018
Who cannot join
- patients who underwent re-transplantation
- patients who were previously diagnosed with end-stage renal disease or Chronic kidney disease
- patients who were being treated with continuous renal replacement therapy
- preoperative or postoperative Antithrombin III levels were not available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Preoperative Antithrombin III Level is Associated With Postoperative Acute Kidney Injury After Liver Transplantation
The reno-protective effect of Antithrombin III (ATIII) has been well-studied in various animal studies; however, little is known about the effect of ATIII on kidney function in patients undergoing liver transplantation (LT). This study aimed to determine the association between preoperative ATIII level and postoperative acute kidney injury (AKI) after LT (post-LT AKI).
- Conditions
- Liver Transplantation and Antithrombin
- Being tested
- Antithrombin III
- Keywords
- acute kidney injury, antithrombins, liver transplantation
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antithrombin IIIDrug
In liver transplant recipients with baseline antithrombin III levels lower than 50%, exogenous Antithrombin III was administrated during the anhepatic phase of the liver transplant surgery.
| Study group | Role | What they receive |
|---|---|---|
| antithrombin III < 50 % | preoperative antithrombin III levels <50% Receives: Drug: Antithrombin III | |
| Antithrombin III ≥ 50 % | preoperative antithrombin III levels ≥ 50 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute kidney injury
serum creatinine >0.3 mg/dL within POD 2 or increase by >1.5 times within POD 7 according to the criteria set by the Kidney Disease: Improving Global Outcomes (KDIGO) classification
Measured: postoperative 7 day
Secondary outcomes (2)
chronic kidney disease
glomerular filtration rate less than 60 mL∙min-1∙1.73m-2 on two consecutive occasions at least 3 months apart
Measured: postoperative 3 months
early allograft dysfucion
at least one of the following: total bilirubin ≥10 mg/dL on postoperative day (POD) 7, prothrombin time (INR) ≥1.6 on POD 7, and alanine or aspartate aminotransferases >2000 IU/L within POD 7
Measured: postoperative 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start4 Jan 2010
- Primary completion31 Jan 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Liver Transplantation and AntithrombinStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Case-control
- Time perspective
- Other
- Enrolment
- 2,395 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyoung-Sun Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912193
- Sponsor's protocol ID
- 2019-1699
- Status last verified
- May 2021
- First submitted
- 30 May 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Levy JH, Sniecinski RM, Welsby IJ, Levi M. Antithrombin: anti-inflammatory properties and clinical applications. Thromb Haemost. 2016 Apr;115(4):712-28. doi: 10.1160/TH15-08-0687. Epub 2015 Dec 17.
PubMed 26676884Wu R, Kong Y, Yin J, Liang R, Lu Z, Wang N, Zhao Q, Zhou Y, Yan C, Wang F, Liang M. Antithrombin Ⅲ is a Novel Predictor for Contrast Induced Nephropathy After Coronary Angiography. Kidney Blood Press Res. 2018;43(1):170-180. doi: 10.1159/000487499. Epub 2018 Feb 16.
PubMed 29466798Lu Z, Cheng D, Yin J, Wu R, Zhang G, Zhao Q, Wang N, Wang F, Liang M. Antithrombin III Protects Against Contrast-Induced Nephropathy. EBioMedicine. 2017 Mar;17:101-107. doi: 10.1016/j.ebiom.2017.02.009. Epub 2017 Feb 12.
PubMed 28219627Wang F, Zhang G, Lu Z, Geurts AM, Usa K, Jacob HJ, Cowley AW, Wang N, Liang M. Antithrombin III/SerpinC1 insufficiency exacerbates renal ischemia/reperfusion injury. Kidney Int. 2015 Oct;88(4):796-803. doi: 10.1038/ki.2015.176. Epub 2015 Jun 24.
PubMed 26108065Yin J, Wang F, Kong Y, Wu R, Zhang G, Wang N, Wang L, Lu Z, Liang M. Antithrombin III prevents progression of chronic kidney disease following experimental ischaemic-reperfusion injury. J Cell Mol Med. 2017 Dec;21(12):3506-3514. doi: 10.1111/jcmm.13261. Epub 2017 Aug 2.
PubMed 28767184
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Preoperative Antithrombin III Level is Associated With Postoperative Acute Kidney Injury After Liver Transplantation
- ClinicalTrials.gov ID
- NCT04912193
- Acronym / sponsor ID
- 2019-1699
- Conditions
- Liver Transplantation and Antithrombin
- Keywords
- acute kidney injury, antithrombins, liver transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,395 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 4 Jan 2010 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 3 Jun 2021 (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.
The reno-protective effect of Antithrombin III (ATIII) has been well-studied in various animal studies; however, little is known about the effect of ATIII on kidney function in patients undergoing liver transplantation (LT). This study aimed to determine the association between preoperative ATIII level and postoperative acute kidney injury (AKI) after LT (post-LT AKI).
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antithrombin III < 50 % | – | Drug: Antithrombin IIIpreoperative antithrombin III levels <50% |
| Antithrombin III ≥ 50 % | – | –preoperative antithrombin III levels ≥ 50 % |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients who underwent either living- or deceased-donor LT (LDLT, DDLT) from January 2010 to January 2018 in Asan Medical Center.
Key inclusion criteria (1 listed)
- patients who underwent either living- or deceased-donor LT (LDLT, DDLT) from January 2010 to January 2018
Key exclusion criteria (4 listed)
- patients who underwent re-transplantation
- patients who were previously diagnosed with end-stage renal disease or Chronic kidney disease
- patients who were being treated with continuous renal replacement therapy
- preoperative or postoperative Antithrombin III levels were not available
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 |
|---|---|---|
| Antithrombin IIIIn liver transplant recipients with baseline antithrombin III levels lower than 50%, exogenous Antithrombin III was administrated during the anhepatic phase of the liver transplant surgery. | Drug | antithrombin III < 50 % |
Primary outcome
acute kidney injury
Time frame: postoperative 7 day
serum creatinine >0.3 mg/dL within POD 2 or increase by >1.5 times within POD 7 according to the criteria set by the Kidney Disease: Improving Global Outcomes (KDIGO) classification
2 secondary outcomes
chronic kidney disease
Time frame: postoperative 3 months
early allograft dysfucion
Time frame: postoperative 7 day
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 3 Jun 2021.
- Background: PubMed 26676884Levy JH, Sniecinski RM, Welsby IJ, Levi M. Antithrombin: anti-inflammatory properties and clinical applications. Thromb Haemost. 2016 Apr;115(4):712-28. doi: 10.1160/TH15-08-0687. Epub 2015 Dec 17.
- Background: PubMed 29466798Wu R, Kong Y, Yin J, Liang R, Lu Z, Wang N, Zhao Q, Zhou Y, Yan C, Wang F, Liang M. Antithrombin Ⅲ is a Novel Predictor for Contrast Induced Nephropathy After Coronary Angiography. Kidney Blood Press Res. 2018;43(1):170-180. doi: 10.1159/000487499. Epub 2018 Feb 16.
- Background: PubMed 28219627Lu Z, Cheng D, Yin J, Wu R, Zhang G, Zhao Q, Wang N, Wang F, Liang M. Antithrombin III Protects Against Contrast-Induced Nephropathy. EBioMedicine. 2017 Mar;17:101-107. doi: 10.1016/j.ebiom.2017.02.009. Epub 2017 Feb 12.
- Results publication: PubMed 26108065Wang F, Zhang G, Lu Z, Geurts AM, Usa K, Jacob HJ, Cowley AW, Wang N, Liang M. Antithrombin III/SerpinC1 insufficiency exacerbates renal ischemia/reperfusion injury. Kidney Int. 2015 Oct;88(4):796-803. doi: 10.1038/ki.2015.176. Epub 2015 Jun 24.
- Results publication: PubMed 28767184Yin J, Wang F, Kong Y, Wu R, Zhang G, Wang N, Wang L, Lu Z, Liang M. Antithrombin III prevents progression of chronic kidney disease following experimental ischaemic-reperfusion injury. J Cell Mol Med. 2017 Dec;21(12):3506-3514. doi: 10.1111/jcmm.13261. Epub 2017 Aug 2.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Antithrombin, run by Asan Medical Center at 1 site in South Korea.
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 4 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 3 Jun 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 South Korea. 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?
acute kidney injury (time frame: postoperative 7 day). 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 NCT04912193, which also lists 5 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 3 Jun 2021.