NCT04265157

Brief Summary

Liver transplantation was historically associated with massive blood loss. Many factors have contributed to the decline in bleeding and transfusion in the past two decades including refinement of surgical techniques, anesthetics management and the use of point of care guided goal-directed hemostatic therapies. Increasing awareness of the adverse associations of allogenic transfusion has driven the quest for transfusion-free transplantation. Pre-operative management of preoperative anemia and targeted correction of coagulopathy is done to decrease blood transfusion. Liver transplantation is associated with the potential for massive operative blood loss, which has been recognized as one of the main causes of morbidity and mortality after liver transplantation. Therefore, a fine surgical procedure to reduce intraoperative hemorrhage is necessary for favorable outcomes of liver transplantation.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

January 29, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

January 29, 2020

Last Update Submit

February 9, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • The amount of intraoperative blood loss measure by Cubic Cm

    2 hours

Study Arms (2)

Early occlusion of hepatoduodenal ligament

Early occlusion of hepatoduodenal ligament during mobilization of the liver of the recipient by using portal vein clamp or occlusive temporary bands.

Procedure: Surgical technique surgical occlusion

classical occlusion of hepatoduodenal ligament

classical occlusion of hepatoduodenal ligament after mobilization of the liver of the recipient immediately before explantation by suing of portal vein clamp

Procedure: Surgical technique surgical occlusion

Interventions

Occlusion of hepatoduodenal ligament by clamp or occlusive bands

Early occlusion of hepatoduodenal ligamentclassical occlusion of hepatoduodenal ligament

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We will included in the study all patients accepted for Living Donor LiverTransplantation (LDLT) according to hospital protocol

You may qualify if:

  • All patients undergoing Living Donor Liver Transplantation accepted according to hospital protocol
  • All patients with liver Cirrhosis who have Porto systemic collaterals based on ct angiography

You may not qualify if:

  • Acute fulminant liver failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Donohue CI, Mallett SV. Reducing transfusion requirements in liver transplantation. World J Transplant. 2015 Dec 24;5(4):165-82. doi: 10.5500/wjt.v5.i4.165.

    PMID: 26722645BACKGROUND
  • Park YK, Kim BW, Wang HJ, Xu W. Usefulness of the Pinch-Burn-Cut (PBC) technique for recipient hepatectomy in liver transplantation. Korean J Hepatobiliary Pancreat Surg. 2012 Feb;16(1):13-6. doi: 10.14701/kjhbps.2012.16.1.13. Epub 2012 Feb 29.

    PMID: 26388900BACKGROUND
  • Houben P, Khajeh E, Hinz U, Knebel P, Diener MK, Mehrabi A. SEALIVE: the use of technical vessel-sealing devices for recipient hepatectomy in liver transplantation: study protocol for a randomized controlled trial. Trials. 2018 Jul 16;19(1):380. doi: 10.1186/s13063-018-2778-1.

    PMID: 30012178BACKGROUND
  • Choi JU, Hwang S, Ahn CS, Moon DB, Ha TY, Kim KH, Song GW, Jung DH, Park GC, Lee SG. Prolonged occlusion of the hepatoduodenal ligament to reduce risk of bleeding and tumor spread during recipient hepatectomy for living donor liver transplantation. Ann Hepatobiliary Pancreat Surg. 2019 Feb;23(1):61-64. doi: 10.14701/ahbps.2019.23.1.61. Epub 2019 Feb 28.

    PMID: 30863809BACKGROUND
  • Lee KF, Wong J, Cheung SYS, Chong CCN, Hui JWY, Leung VYF, Yu SCH, Lai PBS. Does Intermittent Pringle Maneuver Increase Postoperative Complications After Hepatectomy for Hepatocellular Carcinoma? A Randomized Controlled Trial. World J Surg. 2018 Oct;42(10):3302-3311. doi: 10.1007/s00268-018-4637-3.

    PMID: 29696328BACKGROUND
  • Cleland S, Corredor C, Ye JJ, Srinivas C, McCluskey SA. Massive haemorrhage in liver transplantation: Consequences, prediction and management. World J Transplant. 2016 Jun 24;6(2):291-305. doi: 10.5500/wjt.v6.i2.291.

    PMID: 27358774BACKGROUND
  • Yoon JU, Byeon GJ, Park JY, Yoon SH, Ryu JH, Ri HS. Bloodless living donor liver transplantation: Risk factors, outcomes, and diagnostic predictors. Medicine (Baltimore). 2018 Dec;97(50):e13581. doi: 10.1097/MD.0000000000013581.

    PMID: 30558025BACKGROUND
  • Kornberg A, Witt U, Kornberg J, Ceyhan GO, Mueller K, Friess H, Thrum K. Prognostic Impact of Intraoperative Blood Loss in Liver Transplant Patients with Advanced Hepatocellular Carcinoma. Anticancer Res. 2016 Oct;36(10):5355-5364. doi: 10.21873/anticanres.11109. Epub 2016 Oct 10.

    PMID: 27798899BACKGROUND

Central Study Contacts

Ahmed Elkoussy, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant lecturer

Study Record Dates

First Submitted

January 29, 2020

First Posted

February 11, 2020

Study Start

March 1, 2020

Primary Completion

March 1, 2022

Study Completion

September 1, 2022

Last Updated

February 11, 2020

Record last verified: 2020-02