Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04265157
Other study ID # LDLT
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2020
Est. completion date September 2022

Study information

Verified date February 2020
Source Assiut University
Contact Ahmed Elkoussy, Master
Phone +20010!17739
Email ahmdkoussy91@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date September 2022
Est. primary completion date March 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Acute fulminant liver failure

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Surgical technique surgical occlusion
Occlusion of hepatoduodenal ligament by clamp or occlusive bands

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (8)

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2016 Oct 10. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The amount of intraoperative blood loss measure by Cubic Cm 2 hours
See also
  Status Clinical Trial Phase
Completed NCT02798861 - Controlled Attenuation Parameter (CAP) in Liver Allografts
Completed NCT03527238 - Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine Phase 2
Completed NCT01696331 - Text Messaging for Adherence in Adolescent Liver Transplant Recipients N/A
Recruiting NCT05051605 - Immune Response to COVID-19 Vaccine in Recipients of Living Donor Liver Transplantation
Recruiting NCT05940857 - Sponsor-Initiated OCS Liver Perfusion (OLP-II) Registry
Completed NCT01598987 - Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients. Phase 3
Active, not recruiting NCT05074160 - OCS Liver Perfusion (OLP) Post-Approval Registry
Completed NCT05087550 - Multicenter Study on Organ Acquisition Costs in the Post Re-Allocation Era: Liver Transplantation
Recruiting NCT04836923 - LIFT Intervention in Liver Transplant Candidates N/A
Not yet recruiting NCT03666689 - Outflow Reconstruction in Right Lobe Living Donor Liver Transplantation
Not yet recruiting NCT06088758 - Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool N/A
Terminated NCT01230502 - Mycophenolic Acid (MPA) Monotherapy in Liver Transplantation N/A
Completed NCT00171509 - Efficacy and Safety of Cyclosporine Microemulsion Given Once a Day in Adult Stable Liver Transplant Recipients Phase 4
Not yet recruiting NCT06254248 - Safety of Atezolizumab-Bevacizumab in Liver Transplanted Patients With Advanced Hepatocellular Carcinoma Phase 2
Recruiting NCT06075745 - Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates Phase 2
Completed NCT02057484 - A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant
Active, not recruiting NCT03577431 - Liver Transplantation With Tregs at MGH Phase 1/Phase 2
Recruiting NCT06342557 - Transitional ePRO Diary Liver
Recruiting NCT02863250 - Australian and New Zealand Massive Transfusion Registry
Completed NCT00698399 - Serum Markers of Ischemia Reperfusion Injury in Liver Transplant Patients N/A