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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
SOLT Trial 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.Check my eligibility
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.See study design
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.
SOLT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year post-transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility -Accrual
Secondary outcome measures
Feasibility- enrollment
Liver carcinoma
SOLT 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
1,472 Previous Clinical Trials
484,963 Total Patients Enrolled
12 Trials studying Surgery
11,059 Patients Enrolled for Surgery
Gonzalo Sapisochin, MD, PhDPrincipal InvestigatorUniversity Health Network, Toronto
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with liver cancer.I am scheduled for or have had a second organ transplant.I have had multiple organ transplants.I am under 18 years old.I am on the waiting list for a liver transplant.I have a liver-related cancer that is not purely hepatocellular carcinoma.
Research Study Groups:
This trial has the following groups:- Group 1: No Autotransfusion
- Group 2: Autotransfusion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies left for volunteers in this experimental trial?
"Unfortunately, according to clinicaltrials.gov records this trial is not currently enrolling patients. Initially posted on January 21st 2023 and last updated in May 12th 2023, the study does not have any recruitment openings at present; however there are 919 other medical trials actively recruiting individuals now."
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