Cardiopulmonary Bypass Induced Red Blood Cell Lysis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-88
SponsorUniversity of Maryland, Baltimore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnant
Non English speaking
Unable to consent or have Legally Authorized Representative (LAR) assent to study
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood and urine collection
Other interventionNo intervention - Biological specimen collection
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Cardiac Sugery Patients Requiring Cardiopulmonary >1hour1 intervention
Trial outcomes
Primary outcomes
1
Hemolysis
Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron
Time frame
Change from baseline at hour 1 during procedure2
Hemolysis
Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron
Time frame
Change from baseline at hour 2 during procedure3
Hemolysis
Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron
Time frame
Change from baseline at hour 3 during procedure4
Hemolysis
Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc. Change from Baseline at Hour 1 during procedure
Time frame
Change from baseline at hour 4 during procedureSecondary outcomes
1
Kidney injury
Change in creatinine, KIM-1 and NGAL
Time frame
Change from baseline at hour 1 during procedure2
Kidney injury
Change in creatinine, KIM-1 and NGAL
Time frame
Change from baseline at hour 2 during procedure3
Kidney injury
Change in creatinine, KIM-1 and NGAL
Time frame
Change from baseline at hour 3 during procedure4
Kidney injury
Change in creatinine, KIM-1 and NGAL
Time frame
Change from baseline at hour 4 during procedureOther outcomes
1
Blood cell function
CBC and red blood cell deformability
Time frame
Change from baseline at hour 1 during procedure2
Blood cell function
CBC and red blood cell deformability
Time frame
Change from baseline at hour 2 during procedure3
Blood cell function
CBC and red blood cell deformability
Time frame
Change from baseline at hour 3 during procedure4
Blood cell function
CBC and red blood cell deformability
Time frame
Change from baseline at hour 4 during procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Maryland, Baltimore
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov