Cardiopulmonary Bypass Induced Red Blood Cell Lysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood and urine collection.
- Who it may be relevant to
- Registry conditions: Cardiopulmonary Bypass, Cardiac Surgery, Kidney Injury, Acute. Basic parameters: 18 years — 88 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Extra-Cellular Hemoglobin, Organ Injury in Extended Cardiopulmonary Bypass
Overview
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.
Detailed description
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.
Interventions
- Other Blood and urine collection
No intervention - Biological specimen collection
Primary outcome measures
- Hemolysis [Time frame: Change from baseline at hour 1 during procedure]
- Hemolysis [Time frame: Change from baseline at hour 2 during procedure]
- Hemolysis [Time frame: Change from baseline at hour 3 during procedure]
- Hemolysis [Time frame: Change from baseline at hour 4 during procedure]
- Hemolysis [Time frame: Change from baseline at hour 4 post procedure]
- Hemolysis [Time frame: Change from baseline at hour 2 post procedure]
- Hemolysis [Time frame: Change from baseline at hour 24 post procedure]
- Hemolysis [Time frame: Change from baseline on day 2 post procedure]
- Hemolysis [Time frame: Change from baseline on day 3 post procedure]
- Hemolysis [Time frame: Change from baseline on day 4 post procedure]
Secondary outcome measures (10)
- Kidney injury [Time frame: Change from baseline at hour 1 during procedure]
- Kidney injury [Time frame: Change from baseline at hour 2 during procedure]
- Kidney injury [Time frame: Change from baseline at hour 3 during procedure]
- Kidney injury [Time frame: Change from baseline at hour 4 during procedure]
- Kidney injury [Time frame: Change from baseline at hour 2 post procedure]
- Kidney injury [Time frame: Change from baseline at hour 24 post procedure]
- Kidney injury [Time frame: Change from baseline at 2 days post procedure]
- Kidney injury [Time frame: Change from baseline at 3 days post procedure]
- Kidney injury [Time frame: Change from baseline at 4 days post procedure]
- Kidney injury [Time frame: Change from baseline at 5 days post procedure]
Eligibility criteria
Inclusion criteria
- Admitted to UMMC for cardiac procedure
- Age: >/=18 y.o TO 88 y.o.
- Undergoing CPB >1hr for the following surgeries (a) complex cardiac surgery (b) heart valve replacement surgery OR (c) CABG surgery.
Exclusion criteria
- Pregnant
- Non English speaking
- Unable to consent or have Legally Authorized Representative (LAR) assent to study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Center for Blood Oxygen Transport and Hemostasis — Baltimore
Identifiers
NCT: NCT05189262 · HP-00094849 · 1R01HL162120-01