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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL162120-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Studying the dynamics of red blood cell lysis, pfH, protective proteins and organ injury, limits will be set for safe levels of pfH following the use of CPB. These results will be compared to existing laboratory-based methods for determining red blood cell damage to predict CPB assist device safety. Further, results from the studies described in this proposal will help develop therapeutic strategies to benefit patients by early detection of pfH and clearance protein levels that occur during CPB.
Cost estimates for brain, lung, cardiac, and kidney complications following complex cardiac surgeries that require a medical assist device to by-pass the heart and lungs (cardiopulmonary bypass, CPB) is estimated to cost $80 million per individual states in the US over a ten-year period. These extra costs represent a significant burden on the healthcare system but could be reduced by understanding how medical assist devices lead to organ injury associated with complex cardiac surgeries. The primary goals of this research are to (1) understand how hemoglobin released into plasma (pfH) from damaged red blood cells that passage through CPB contributes to organ injury. (2) Determine the amount of pfH necessary to cause organ injury. (3) Determine the concentration changes in protective proteins (called haptoglobin, hemopexin and transferrin) that remove pfH and its degradation products from the circulation. (4) Design a computer-based model that will determine the levels of pfH and protective proteins to predict the potential for organ injury. By studying the dynamics of red blood cell lysis, pfH, protective proteins and organ injury limits will be set for safe levels of pfH following the use of CPB. These results will be compared to existing laboratory-based methods for determining red blood cell damage to predict CPB assist device safety. Further, results from the studies described in this proposal will help develop therapeutic strategies to benefit patients by early detection of pfH and clearance protein levels that occur during CPB. The primary goals of this research are to (1) understand how hemoglobin released into plasma (pfH) from damaged red blood cells that passage through CPB contributes to organ injury. (2) Determine the amount of pfH necessary to cause organ injury. (3) Determine the concentration changes in protective proteins (called haptoglobin, hemopexin and transferrin) that remove pfH and its degradation products from the circulation. (4) Design a computer-based model that will determine the levels of pfH and protective proteins to predict the potential for organ injury. By studying the dynamics of red blood cell lysis, pfH, protective proteins and organ injury limits will be set for safe levels of pfH following the use of CPB. These results will be compared to existing laboratory-based methods for determining red blood cell damage to predict CPB assist device safety. Further, results from the studies described in this proposal will help develop therapeutic strategies to benefit patients by early detection of pfH and clearance protein levels that occur during CPB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac Sugery Patients Requiring Cardiopulmonary >1hour | Patients admitted for a complex cardiac surgery, heart valve replacement and/or CABG surgery requiring CPB >1hour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood and urine collection | Other | No intervention - Biological specimen collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemolysis | Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron | Change from baseline at hour 1 during procedure |
| Hemolysis | Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron | Change from baseline at hour 2 during procedure |
| Hemolysis | Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron | Change from baseline at hour 3 during procedure |
| Hemolysis | Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc. Change from Baseline at Hour 1 during procedure | Change from baseline at hour 4 during procedure |
| Hemolysis | Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc. Change from Baseline at Hour 1 during procedure | Change from baseline at hour 4 post procedure |
| Hemolysis | Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc. Change from Baseline at Hour 1 during procedure | Change from baseline at hour 2 post procedure |
| Hemolysis | Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc. Change from Baseline at Hour 1 during procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Kidney injury | Change in creatinine, KIM-1 and NGAL | Change from baseline at hour 1 during procedure |
| Kidney injury | Change in creatinine, KIM-1 and NGAL |
| Measure | Description | Time Frame |
|---|---|---|
| Blood cell function | CBC and red blood cell deformability | Change from baseline at hour 1 during procedure |
| Blood cell function | CBC and red blood cell deformability |
Inclusion Criteria:
Exclusion Criteria:
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Research Participants will include approximately 90 adult (>/=18 years of age to 75 years of age) medium to high risk patients. Both Male and female subjects who are undergoing complex cardiac surgery requiring, heart valve replacement, or CABG surgery requiring cardiopulmonary bypass >1hr will be eligible for enrollment at the University of Maryland Medical Center (UMMC) in Baltimore, MD. This study is a prospective observational investigation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul W Buehler, PhD | Contact | 14107065171 | pbuehler@som.umaryland.edu | |
| Tobi Rowden, RN | Contact | 4107064061 | trowden@som.umaryland.edu |
| Name | Affiliation | Role |
|---|---|---|
| Paul Buehler, PhD | University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Blood Oxygen Transport and Hemostasis | Recruiting | Baltimore | Maryland | 21201 | United States |
Deidentified data may be used in a publication
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D059349 | Urine Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Red blood cells, plasma and urine
| Change from baseline at hour 24 post procedure |
| Hemolysis | Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc. Change from Baseline at Hour 1 during procedure | Change from baseline on day 2 post procedure |
| Hemolysis | Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc. Change from Baseline at Hour 1 during procedure | Change from baseline on day 3 post procedure |
| Hemolysis | Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc. Change from Baseline at Hour 1 during procedure | Change from baseline on day 4 post procedure |
| Hemolysis | Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc. Change from Baseline at Hour 1 during procedure | Change from baseline on day 5 post procedure |
| Change from baseline at hour 2 during procedure |
| Kidney injury | Change in creatinine, KIM-1 and NGAL | Change from baseline at hour 3 during procedure |
| Kidney injury | Change in creatinine, KIM-1 and NGAL | Change from baseline at hour 4 during procedure |
| Kidney injury | Change in creatinine, KIM-1 and NGAL | Change from baseline at hour 2 post procedure |
| Kidney injury | Change in creatinine, KIM-1 and NGAL | Change from baseline at hour 24 post procedure |
| Kidney injury | Change in creatinine, KIM-1 and NGAL | Change from baseline at 2 days post procedure |
| Kidney injury | Change in creatinine, KIM-1 and NGAL | Change from baseline at 3 days post procedure |
| Kidney injury | Change in creatinine, KIM-1 and NGAL | Change from baseline at 4 days post procedure |
| Kidney injury | Change in creatinine, KIM-1 and NGAL | Change from baseline at 5 days post procedure |
| Change from baseline at hour 2 during procedure |
| Blood cell function | CBC and red blood cell deformability | Change from baseline at hour 3 during procedure |
| Blood cell function | CBC and red blood cell deformability | Change from baseline at hour 4 during procedure |
| Blood cell function | CBC and red blood cell deformability | Change from baseline at hour 2 post procedure |
| Blood cell function | CBC and red blood cell deformability | Change from baseline at hour 24 post procedure |
| Blood cell function | CBC and red blood cell deformability | Change from baseline at day 2 post procedure |
| Blood cell function | CBC and red blood cell deformability | Change from baseline at day 3 post procedure |
| Blood cell function | CBC and red blood cell deformability | Change from baseline at day 4 post procedure |
| Blood cell function | CBC and red blood cell deformability | Change from baseline at day 5 post procedure |
| Outcome Hemoglobin Clearance | Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations | Change from baseline at hour 1 during procedure |
| Outcome Hemoglobin Clearance | Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations | Change from baseline at hour 2 during procedure |
| Outcome Hemoglobin Clearance | Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations | Change from baseline at hour 3 during procedure |
| Outcome Hemoglobin Clearance | Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations | Change from baseline at hour 4 during procedure |
| Outcome Hemoglobin Clearance | Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations | Change from baseline at hour 2 post procedure |
| Outcome Hemoglobin Clearance | Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations | Change from baseline at hour 24 post procedure |
| Outcome Hemoglobin Clearance | Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations | Change from baseline at day 2 post procedure |
| Outcome Hemoglobin Clearance | Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations | Change from baseline at day 3 post procedure |
| Outcome Hemoglobin Clearance | Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations | Change from baseline at day 4 post procedure |
| Outcome Hemoglobin Clearance | Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations | Change from baseline at day 5 post procedure |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |