Transfusion Related ComplicationEarly Phase 1NCT04383756
Utilization of Donor Whole Blood for Blood Transfusion in Deceased Donor Liver Transplantation
A Early Phase 1 study testing Donor Blood and Banked Blood in people with Transfusion Related Complication and Liver Transplant, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
We will study 40 matched patients. 20 patients will receive leukoreduced whole blood from the solid organ donor. These 20 patients will be compared to 20 historical matched controls with regards to allogenic blood product usage and other physiologic markers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transfusion Related Complication, Liver Transplant
- What is being tested?
- Donor Blood and Banked Blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2020to Jul 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Recipients 18 years or older.
- Deceased donor whole graft liver transplant recipients undergoing liver transplant starting 07/01/2020 and onwards at VUMC.
- ABO-matched recipient and donor.
- Donor Hb level >/= 8 g/dL
- Recipients with negative ABO antibody screen
Who cannot join
- - Pediatric recipient.
- HBS Antigen+ donors
- HCV NAT+ donors
- Donors of A2 blood type
- Donors on oral anticoagulants (except for aspirin) over the past 3 days before organ procurement
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37205
About this study
We will study 40 matched patients. 20 patients will receive leukoreduced whole blood from the solid organ donor. These 20 patients will be compared to 20 historical matched controls with regards to allogenic blood product usage and other physiologic markers
- Conditions
- Transfusion Related Complication, Liver Transplant
- Being tested
- Donor Blood, Banked Blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donor BloodBiological
Up to 4 units (each unit contains 350mL) of leukoreduced donor whole blood
Banked BloodBiological
Up to 350mL of Allogenic banked component blood transfusion in a 1:1:1 manner (packed red blood cells : plasma : platelets)
| Study group | Role | What they receive |
|---|---|---|
| Donor Blood | Experimental | Between 2-4 units of donor leukoreduced whole blood (each unit will contain up to 350mL) transfused as needed in Liver transplantation participants Receives: Biological: Donor Blood |
| Banked Blood | Active comparator | Standard of Care - Up to 350mL Allogenic banked component blood transfusion in a 1:1:1 manner (packed red blood cells : plasma : platelets) transfused as needed in Liver transplantation participants Receives: Biological: Banked Blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of allogenic banked blood products
Measured by the number of allogenic banked blood products used
Measured: perioperative up to 72 hours post operative
Economic cost
Total cost of perioperative transfusions
Measured: perioperative up to 72 hours post operative
Secondary outcomes (1)
Number of Serious Adverse Events (SAEs)
Number of deaths, life-threatening events, hospitalizations, disabilities or permanent damage, or congenital anomalies
Measured: Baseline to discharge (approximately 4-5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study startDec 2020 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Why it stopped: Study was never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfusion Related ComplicationStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 20 recipients receive donor whole blood 20 historic match controls are compared to the 20 study participants
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clayne Benson, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383756
- Sponsor's protocol ID
- UDWBBT
- Status last verified
- May 2020
- First submitted
- 7 May 2020
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Donor Whole Blood for Blood Transfusion in Deceased Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT04383756
- Acronym / sponsor ID
- UDWBBT
- Conditions
- Transfusion Related Complication, Liver Transplant
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will study 40 matched patients. 20 patients will receive leukoreduced whole blood from the solid organ donor. These 20 patients will be compared to 20 historical matched controls with regards to allogenic blood product usage and other physiologic markers
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 20 recipients receive donor whole blood 20 historic match controls are compared to the 20 study participants
| Arm | Type | Receives |
|---|---|---|
| Donor Blood | Experimental | Biological: Donor BloodBetween 2-4 units of donor leukoreduced whole blood (each unit will contain up to 350mL) transfused as needed in Liver transplantation participants |
| Banked Blood | Active comparator | Biological: Banked BloodStandard of Care - Up to 350mL Allogenic banked component blood transfusion in a 1:1:1 manner (packed red blood cells : plasma : platelets) transfused as needed in Liver transplantation participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - Recipients 18 years or older.
- Deceased donor whole graft liver transplant recipients undergoing liver transplant starting 07/01/2020 and onwards at VUMC.
- ABO-matched recipient and donor.
- Donor Hb level >/= 8 g/dL
- Recipients with negative ABO antibody screen
Key exclusion criteria (5 listed)
- - Pediatric recipient.
- HBS Antigen+ donors
- HCV NAT+ donors
- Donors of A2 blood type
- Donors on oral anticoagulants (except for aspirin) over the past 3 days before organ procurement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donor BloodUp to 4 units (each unit contains 350mL) of leukoreduced donor whole blood | Biological | Donor Blood |
| Banked BloodUp to 350mL of Allogenic banked component blood transfusion in a 1:1:1 manner (packed red blood cells : plasma : platelets) | Biological | Banked Blood |
Primary outcome
Use of allogenic banked blood products
Time frame: perioperative up to 72 hours post operative
Measured by the number of allogenic banked blood products used
Economic cost
Time frame: perioperative up to 72 hours post operative
Total cost of perioperative transfusions
1 secondary outcome
Number of Serious Adverse Events (SAEs)
Time frame: Baseline to discharge (approximately 4-5 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clayne Benson, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Donor Blood and Banked Blood in people with Transfusion Related Complication and Liver Transplant, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of allogenic banked blood products (time frame: perioperative up to 72 hours post operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.