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Blood Salvage

Autotransfusion During Liver Transplant for Liver Cancer (SOLT Trial)

N/A
Waitlist Available
Led By Gonzalo Sapisochin, MD, PhD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post-transplant
Awards & highlights
No Placebo-Only Group

Summary

This trial will evaluate the safety and effectiveness of using a patient’s own blood during liver transplant surgery to reduce the need for donor blood.

Who is the study for?
This trial is for adults with Hepatocellular carcinoma (HCC) who are listed for a liver transplant. It excludes those with other cancers like mixed cholangiocarcinoma-HCC, cholangiocarcinoma, metastatic colorectal cancer, children under 18, and patients undergoing re-transplantation or multi-organ transplantation.
What is being tested?
The study tests the use of intraoperative blood cell salvage and autotransfusion (IBSA), where a patient's own blood collected during surgery is cleaned and returned to them. The trial will compare outcomes between patients receiving their own salvaged blood versus those whose collected blood is discarded.
What are the potential side effects?
While specific side effects of IBSA are not detailed here, potential risks may include reactions related to transfusion such as fever or allergic responses, and complications from incorrect handling of salvaged blood.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility -Accrual
Secondary study objectives
Feasibility- enrollment
Liver carcinoma

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AutotransfusionExperimental Treatment1 Intervention
patients in this arm will receive their salvaged and washed RBCs via transfusion
Group II: No AutotransfusionActive Control1 Intervention
patients in this arm will have their salvaged and washed RBCs discarded.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Autotransfusion
2019
N/A
~620

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,520 Previous Clinical Trials
503,214 Total Patients Enrolled
12 Trials studying Surgery
11,059 Patients Enrolled for Surgery
Gonzalo Sapisochin, MD, PhDPrincipal InvestigatorUniversity Health Network, Toronto

Media Library

IBSA (Blood Salvage) Clinical Trial Eligibility Overview. Trial Name: NCT05612477 — N/A
Surgery Research Study Groups: Autotransfusion, No Autotransfusion
Surgery Clinical Trial 2023: IBSA Highlights & Side Effects. Trial Name: NCT05612477 — N/A
IBSA (Blood Salvage) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05612477 — N/A
~1 spots leftby Dec 2024
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