NCT04912193

Brief 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). This study aimed to determine the association between preoperative ATIII level and postoperative acute kidney injury (AKI) after LT (post-LT AKI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,395

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2010

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
Last Updated

June 3, 2021

Status Verified

May 1, 2021

Enrollment Period

9.1 years

First QC Date

May 30, 2021

Last Update Submit

May 30, 2021

Conditions

Liver Transplantation and Antithrombin

Keywords

acute kidney injuryantithrombinsliver transplantation

Outcome Measures

Primary Outcomes (1)

  • 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

    postoperative 7 day

Secondary Outcomes (2)

  • chronic kidney disease

    postoperative 3 months

  • early allograft dysfucion

    postoperative 7 day

Study Arms (2)

antithrombin III < 50 %

preoperative antithrombin III levels \<50%

Drug: Antithrombin III

Antithrombin III ≥ 50 %

preoperative antithrombin III levels ≥ 50 %

Interventions

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.

antithrombin III < 50 %

Eligibility Criteria

Age19 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who underwent either living- or deceased-donor LT (LDLT, DDLT) from January 2010 to January 2018 in Asan Medical Center.

You may qualify if:

  • patients who underwent either living- or deceased-donor LT (LDLT, DDLT) from January 2010 to January 2018

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05507, South Korea

Location

Related Publications (5)

  • 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.

    PMID: 26676884BACKGROUND

  • Wu 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.

    PMID: 29466798BACKGROUND

  • Lu 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.

    PMID: 28219627BACKGROUND

  • Wang 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.

    PMID: 26108065RESULT

  • Yin 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.

    PMID: 28767184RESULT

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Antithrombin III

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antithrombin ProteinsSerpinsPeptidesAmino Acids, Peptides, and ProteinsAlpha-GlobulinsSerum GlobulinsBlood ProteinsProteinsGlobulinsBlood Coagulation Factor InhibitorsBiological Factors

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Clinical Fellow

Study Record Dates

First Submitted

May 30, 2021

First Posted

June 3, 2021

Study Start

January 4, 2010

Primary Completion

January 31, 2019

Study Completion

December 31, 2019

Last Updated

June 3, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
starting 6 months after publication

Locations

KR(1)