Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R38OT15491 | Other Grant/Funding Number | HRSA |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Health Resources and Services Administration (HRSA) | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard DCD liver transplant | Active Comparator | Standard method of liver transplant utilizing a DCD organ |
|
| rTPA Treatment Liver Transplant | Active Comparator | Ex-vivo treatment of liver donated after cardiac death (DCD) with rTPA |
|
| Standard DCD kidney transplant | Active Comparator | Standard method of kidney transplant utilizing a DCD organ |
|
| rTPA Treatment Kidney Transplant | Active Comparator | Ex-vivo treatment of kidney donated after cardiac death (DCD) with rTPA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTPA Treatment | Drug | Ex-vivo treatment of DCD liver or kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delayed Kidney Graft Function | 3 months | |
| Number of Participants With Primary Liver Graft Nonfunction | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Liver Ischemic-Type Biliary Strictures | 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bijan Eghtesad, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals / Case medical Center | Cleveland | Ohio | 44106 | United States | ||
| Cleveland Clinic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
DCD donors from 2010 to 2013.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard DCD Liver Transplant | Standard method of liver transplant utilizing a DCD organ |
| FG001 | rTPA Treatment - Liver | Ex-vivo treatment of liver donated after cardiac death (DCD)with rTPA rTPA Treatment: Ex-vivo treatment of DCD liver with rTPA (recombinant tissue plasminogen activator)prior to implantation |
| FG002 | Standard DCD Kidney Transplant | Standard method of kidney transplant utilizing a DCD organ |
| FG003 | rTPA Treatment - Kidney | Ex-vivo treatment of kidney donated after cardiac death (DCD)with rTPA rTPA Treatment: Ex-vivo treatment of DCD kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard DCD Liver Transplant | Standard method of liver transplant utilizing a DCD organ |
| BG001 | rTPA Treatment - Liver | Ex-vivo treatment of liver donated after cardiac death (DCD)with rTPA rTPA Treatment: Ex-vivo treatment of DCD liver with rTPA (recombinant tissue plasminogen activator)prior to implantation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Delayed Kidney Graft Function | Posted | Count of Participants | Participants | 3 months |
|
|
One Year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard DCD Liver Transplant | Standard method of liver transplant utilizing a DCD organ |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Primary non -function | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delayed Graft Function | Surgical and medical procedures | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bijan Eghtesad, MD | Cleveland Clinic | 216 444-9898 | eghtesb@ccf.org |
Not provided
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| No TPA Treatment | Other | Standard of Care |
|
| Cleveland |
| Ohio |
| 44195 |
| United States |
| BG002 | rTPA Treatment - Kidney | Ex-vivo treatment of kidney donated after cardiac death (DCD)with rTPA rTPA Treatment: Ex-vivo treatment of DCD kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation |
| BG003 | Standard DCD Kidney Transplant | Standard method of kidney transplant utilizing a DCD organ |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Number of Participants With Primary Liver Graft Nonfunction | Posted | Count of Participants | Participants | No | 1 month |
|
|
|
| Secondary | Number of Participants With Liver Ischemic-Type Biliary Strictures | Posted | Count of Participants | Participants | No | 1 year |
|
|
|
| 6 |
| 33 |
| 3 |
| 33 |
| 12 |
| 33 |
| EG001 | rTPA Treatment - Liver | Ex-vivo treatment of liver donated after cardiac death (DCD)with rTPA rTPA Treatment: Ex-vivo treatment of DCD liver with rTPA (recombinant tissue plasminogen activator)prior to implantation | 12 | 46 | 2 | 46 | 8 | 46 |
| EG002 | rTPA Treatment - Kidney | Ex-vivo treatment of kidney donated after cardiac death (DCD)with rTPA rTPA Treatment: Ex-vivo treatment of DCD kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation | 0 | 12 | 2 | 12 | 5 | 12 |
| EG003 | Standard DCD Kidneytransplant | Standard method of kidney transplant utilizing a DCD organ | 0 | 12 | 2 | 12 | 7 | 12 |
| Necrosis | Surgical and medical procedures | Systematic Assessment | Necrotic Right Colon |
|
| Bleeding | Surgical and medical procedures | Systematic Assessment |
|
| Urinary Leak | Surgical and medical procedures | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |