Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This single-centre randomized pilot study will investigate the feasibility, safety, and efficacy of IBSA (intraoperative blood cell salvage and autotransfusion -when a patient's own blood is collected from the surgical field, washed, and transfused back to them), in patients undergoing Liver transplantation for Hepatocellular carcinoma (HCC).
A total of 30 patient participants will be enrolled. A participant will be randomized only if enough blood is collected during the transplant surgery to produce a minimum of 1 unit of autologous blood. Patients will be randomized to receive their blood back (via transfusion) or have their own blood discarded. Patients will be followed after surgery for evaluation of safety and efficacy.
Depending on the outcomes of this feasibility trial, a subsequent larger full-scale multi-institutional trial will be planned, which will be more appropriately powered to evaluate the true impact of IBSA on the use of allogeneic blood products and post-transplant HCC-specific outcomes.
Blood loss during liver transplantation (LT) often necessitates transfusion. However, allogeneic blood transfusion (blood from a donor) has risks. For this reason, intraoperative blood cell salvage and autotransfusion (IBSA) is frequently deployed to reduce the need for allogeneic blood transfusion. While IBSA is often used in LT, it is rarely used in patients undergoing LT for hepatocellular carcinoma (HCC) due to the theoretical risk of re-infusing cancer cells.
This single-centre, randomized, pilot study, will investigate the feasibility, safety, and efficacy of IBSA in patients undergoing LT for HCC.
Patients with HCC, listed for a Liver Transplant at the study institution, will be consented in clinic. At the time of liver transplant surgery, patients will be randomized, provided that enough blood is collected to generate a minimum of 1 unit of washed RBCs to give back. Participants randomized to arm 1 will receive their autologous blood via transfusion. Participants randomized to arm 2 will not receive their autologous blood - instead the blood will be discarded. Following surgery, participants will be followed for evaluation of safety and efficacy outcomes related to overall transfusions requirements and cancer recurrence.
The primary outcome is an evaluation of how many patients who consent to the trial will experience enough blood loss during surgery to be randomizable according to the study design (producing a minimum of 1 unit of washed RBCs).
Secondary outcomes include: whether the study can meet its accrual and enrollment goals within the study period; a comparison of rates of patient survival and HCC recurrence between the study groups; a comparison of the patient characteristics of those randomized to those not randomized. Blood will also be collected for correlative studies.
Depending on the outcomes of this feasibility trial, a subsequent larger full-scale multi-institutional trial will be planned, which will be more appropriately powered to evaluate the true impact of IBSA on the use of allogeneic blood products and post-transplant HCC-specific outcomes.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autotransfusion | Experimental | patients in this arm will receive their salvaged and washed RBCs via transfusion |
|
| No Autotransfusion | No Intervention | patients in this arm will have their salvaged and washed RBCs discarded. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autotransfusion | Procedure | blood is collected from the surgical field, washed, processed and transfused back into the patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility -Accrual | The primary outcome is an evaluation of how many patients who consent to the trial will experience enough blood loss during surgery to be randomizable according to the study design. This will be measured by comparing the number of consented patients undergoing LT who meet randomization requirements compared to those who do not. | through study completion, an average of 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility- enrollment | to determine whether we can meet enrollment goals within the study period | 15 months |
| Safety- HCC recurrence | compare rates of HCC recurrence between groups |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gonzalo Sapisochin, MD, PhD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Toronto | Ontario | M5G 2N2 | Canada |
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D001804 | Blood Transfusion, Autologous |
| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 year post-transplant |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |