Trial Outcomes & Findings for Purge Vs no Purge in Living Donor Liver Transplantation Recipients (NCT NCT02540447)

NCT ID: NCT02540447

Last Updated: 2017-04-26

Results Overview

The lowest of three recorded mean arterial pressure readings at 1,3 and 5 minutes after portal declamping

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: 5 minutes post-reperfusion
• Results posted on: 2017-04-26

Participant Flow

Candidates recruited from patients admitted for living donor liver transplantation in Mansoura liver transplantation unit

Participant milestones

Measure	Purge The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture" that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis. Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping	No Purge The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
Overall Study STARTED	40	40
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Purge Vs no Purge in Living Donor Liver Transplantation Recipients

Baseline characteristics by cohort

Measure	Purge n=40 Participants The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture" that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis. Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping	No Purge n=40 Participants The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.	Total n=80 Participants Total of all reporting groups
Age, Continuous	51.5 years STANDARD_DEVIATION 6.19 • n=5 Participants	50.9 years STANDARD_DEVIATION 7.62 • n=7 Participants	51.15 years STANDARD_DEVIATION 6.94 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	34 Participants n=7 Participants	66 Participants n=5 Participants
Region of Enrollment Egypt	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 minutes post-reperfusion

The lowest of three recorded mean arterial pressure readings at 1,3 and 5 minutes after portal declamping

Outcome measures

Measure	Purge n=40 Participants Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture" that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis. Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping	No Purge n=40 Participants Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure	66.03 mmHg Standard Deviation 6.13	57.75 mmHg Standard Deviation 5.91

SECONDARY outcome

Timeframe: 3 months

Participants who developed biliary complications in three months period (Participant)

Outcome measures

Measure	Purge n=40 Participants Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture" that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis. Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping	No Purge n=40 Participants Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
Biliary Complications (Participants)	10 participants	6 participants

SECONDARY outcome

Timeframe: 7 days

incidence of ischemia reperfusion injury in the transplanted graft

Outcome measures

Measure	Purge n=40 Participants Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture" that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis. Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping	No Purge n=40 Participants Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
Ischemia Reperfusion Injury	3 participants	2 participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	Purge n=40 Participants Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture" that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis. Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping	No Purge n=40 Participants Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
Post-operative Infectious Complications	9 participants	8 participants

SECONDARY outcome

Timeframe: 3 Months

mortality within first 3 post-operative months

Outcome measures

Measure	Purge n=40 Participants Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture" that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis. Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping	No Purge n=40 Participants Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
3 Months Mortality	4 participants	3 participants

Adverse Events

Purge

Serious events: 4 serious events

Other events: 18 other events

Deaths: 0 deaths

No Purge

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Purge n=40 participants at risk The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture" that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis. Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping	No Purge n=40 participants at risk The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
Surgical and medical procedures 3 Months Mortality	10.0% 4/40 • Number of events 4 • 3 months complications	7.5% 3/40 • Number of events 3 • 3 months complications

Other adverse events

Measure	Purge n=40 participants at risk The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture" that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis. Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping	No Purge n=40 participants at risk The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
Surgical and medical procedures 30 days morbidity	45.0% 18/40 • Number of events 35 • 3 months complications	37.5% 15/40 • Number of events 34 • 3 months complications
Infections and infestations Infectious complications (30 days)	12.5% 5/40 • Number of events 9 • 3 months complications	15.0% 6/40 • Number of events 8 • 3 months complications
Immune system disorders Acute cellular rejection (30 Days)	30.0% 12/40 • Number of events 12 • 3 months complications	37.5% 15/40 • Number of events 15 • 3 months complications
General disorders Ischemia/Reperfusion Injury (30 days)	7.5% 3/40 • Number of events 3 • 3 months complications	5.0% 2/40 • Number of events 2 • 3 months complications
Hepatobiliary disorders Billiary complications (30 Days)	25.0% 10/40 • Number of events 10 • 3 months complications	15.0% 6/40 • Number of events 6 • 3 months complications
Vascular disorders Vascular complications (30 Days)	2.5% 1/40 • Number of events 1 • 3 months complications	2.5% 1/40 • Number of events 1 • 3 months complications

Additional Information

Amr Mohamed Yassen Ali Badawy

Mansoura Faculty of Medicine

Phone: +201001497044

Email: amryassen@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place