Liver TransplantationNCT01197573
Enhancing Donated After Cardiac Death (DCD) Utilization With Thrombolytic Therapy
A study testing rTPA Treatment and No TPA Treatment in people with Liver Transplantation and Kidney Transplantation, run by The Cleveland Clinic at 2 sites in United States.
Trial summary
We hypothesize that delayed graft function and ITBS events may be related to small blood clots (microthrombi) that collect in the kidneys and liver after cardiac death. Treatment of the DCD organs with a thrombolytic agent prior to implantation may reduce post-transplant morbidity and mortality, and may ultimately… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, Kidney Transplantation
- What is being tested?
- rTPA Treatment and No TPA Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adults aged 18 years and older
- Subjects willing/able to provide written consent
- Subjects willing/able to comply with study requirements
- Subjects who will receive a solitary organ transplant
Who cannot join
- Subjects requiring multi-organ transplants
- Women who are pregnant
- Subjects with current severe systemic infection
- Subjects with an active infection
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Hospitals / Case medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
About this study
Official title: Enhancing DCD Utilization With Thrombolytic Therapy
We hypothesize that delayed graft function and ITBS events may be related to small blood clots (microthrombi) that collect in the kidneys and liver after cardiac death. Treatment of the DCD organs with a thrombolytic agent prior to implantation may reduce post-transplant morbidity and mortality, and may ultimately result in a greater number of transplantable livers and kidneys.
Read the detailed description
The waiting list for kidney and liver transplantation continues to increase in the United States, and therefore the need grows for additional donor organs. Utilization of organs donated after cardiac death (DCD) could be one way to increase organ availability, however there are risks associated with poorer clinical outcomes, including delayed graft function and in livers specifically, ischemic-type biliary strictures (ITBS). We hypothesize that delayed graft function and ITBS events may be related to small blood clots (microthrombi) that collect in the kidneys and liver after cardiac death. Treatment of the DCD organs with a thrombolytic agent prior to implantation may reduce post-transplant morbidity and mortality, and may ultimately result in a greater number of transplantable livers and kidneys.
- Conditions
- Liver Transplantation, Kidney Transplantation
- Being tested
- rTPA Treatment, No TPA Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTPA TreatmentDrug
Also called Alteplase
Ex-vivo treatment of DCD liver or kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation
No TPA TreatmentOther
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Standard DCD liver transplant | Active comparator | Standard method of liver transplant utilizing a DCD organ Receives: Other: No TPA Treatment |
| rTPA Treatment Liver Transplant | Active comparator | Ex-vivo treatment of liver donated after cardiac death (DCD) with rTPA Receives: Drug: rTPA Treatment |
| Standard DCD kidney transplant | Active comparator | Standard method of kidney transplant utilizing a DCD organ Receives: Other: No TPA Treatment |
| rTPA Treatment Kidney Transplant | Active comparator | Ex-vivo treatment of kidney donated after cardiac death (DCD) with rTPA Receives: Drug: rTPA Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed Kidney Graft Function
Measured: 3 months
Number of Participants With Primary Liver Graft Nonfunction
Measured: 1 month
Secondary outcomes (1)
Number of Participants With Liver Ischemic-Type Biliary Strictures
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2015
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Principal investigator, Bijan Eghtesad, MD, The Cleveland Clinic
- Investigators
- Bijan Eghtesad, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197573
- Sponsor's protocol ID
- CCIRB: 10-365
- Other IDs
- R38OT15491
- Status last verified
- Jul 2018
- First submitted
- 8 Sep 2010
- Last updated
- 28 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing DCD Utilization With Thrombolytic Therapy
- ClinicalTrials.gov ID
- NCT01197573
- Acronym / sponsor ID
- CCIRB: 10-365
- Conditions
- Liver Transplantation, Kidney Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- Apr 2010
- Primary completion
- Oct 2015 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Posted 28 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesize that delayed graft function and ITBS events may be related to small blood clots (microthrombi) that collect in the kidneys and liver after cardiac death. Treatment of the DCD organs with a thrombolytic agent prior to implantation may reduce post-transplant morbidity and mortality, and may ultimately result in a greater number of transplantable livers and kidneys.
Detailed description
The waiting list for kidney and liver transplantation continues to increase in the United States, and therefore the need grows for additional donor organs. Utilization of organs donated after cardiac death (DCD) could be one way to increase organ availability, however there are risks associated with poorer clinical outcomes, including delayed graft function and in livers specifically, ischemic-type biliary strictures (ITBS). We hypothesize that delayed graft function and ITBS events may be related to small blood clots (microthrombi) that collect in the kidneys and liver after cardiac death. Treatment of the DCD organs with a thrombolytic agent prior to implantation may reduce post-transplant morbidity and mortality, and may ultimately result in a greater number of transplantable livers and kidneys.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard DCD liver transplant | Active comparator | Other: No TPA TreatmentStandard method of liver transplant utilizing a DCD organ |
| rTPA Treatment Liver Transplant | Active comparator | Drug: rTPA TreatmentEx-vivo treatment of liver donated after cardiac death (DCD) with rTPA |
| Standard DCD kidney transplant | Active comparator | Other: No TPA TreatmentStandard method of kidney transplant utilizing a DCD organ |
| rTPA Treatment Kidney Transplant | Active comparator | Drug: rTPA TreatmentEx-vivo treatment of kidney donated after cardiac death (DCD) with rTPA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years and older
- Subjects willing/able to provide written consent
- Subjects willing/able to comply with study requirements
- Subjects who will receive a solitary organ transplant
Key exclusion criteria (4 listed)
- Subjects requiring multi-organ transplants
- Women who are pregnant
- Subjects with current severe systemic infection
- Subjects with an active infection
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 |
|---|---|---|
| rTPA TreatmentAlso: AlteplaseEx-vivo treatment of DCD liver or kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation | Drug | rTPA Treatment Kidney Transplant, rTPA Treatment Liver Transplant |
| No TPA TreatmentStandard of Care | Other | Standard DCD kidney transplant, Standard DCD liver transplant |
Primary outcome
Delayed Kidney Graft Function
Time frame: 3 months
Number of Participants With Primary Liver Graft Nonfunction
Time frame: 1 month
1 secondary outcome
Number of Participants With Liver Ischemic-Type Biliary Strictures
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Liver Transplantation
Not yet recruitingObservational study
Comparison of Liver Biopsy Versus Fibroscan With CAP ( Controlled Attenuation Parameter) in Donors Evaluation for Liver Transplant
Non-invasive Donor Liver Assessment
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Recruiting
In-situ vs Ex-situ Liver Preservation
Liver Disease (Alcoholic or Not), Transplantation
Active, not recruiting
Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
Transplant;Failure,Kidney, Transplant; Failure, Liver
Not yet recruitingPhase 2
A Prospective Study to Evaluate the Efficacy and Safety of Entecavir ODT Conversion in Stable Liver Transplant Patients
Hepatitis B Virus, Liver Transplant
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.
Bijan Eghtesad, MD principal investigator
The Cleveland Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTPA Treatment and No TPA Treatment in people with Liver Transplantation and Kidney Transplantation, run by The Cleveland Clinic at 2 sites 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Delayed Kidney Graft Function (time frame: 3 months). 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 28 Aug 2018.