Sepsis Clinical Trial
Official title:
A RANDOMISED CONTROLLED TRIAL OF RED CELL REJUVENATION FOR THE ATTENUATION OF TRANSFUSION ASSOCIATED ORGAN INJURY IN CARDIAC SURGERY: The REDJUVENATE Trial
NCT number | NCT03167788 |
Other study ID # | 0582 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | December 2020 |
Est. completion date | December 2020 |
Verified date | May 2020 |
Source | University of Leicester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The REDJUVENATE Trial proposes to test the hypothesis that postoperative organ injury and inflammation will be less if patients undergoing cardiac surgery who are at risk of large volume blood transfusion (defined as the administration of ≥4 units of red cells) receive rejuvenated washed cells compared to standard care (unwashed aged stored cells).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Adult cardiac surgery patients (=18 years) undergoing cardiac surgery with cardiopulmonary bypass. 2. Identified as representing a high risk group for massive blood transfusion using a modified risk score. A large volume blood transfusion (LVBT) score of >23 indicates predicted risk of receiving =4 units of allogeneic red cells equal to or greater than 55 per cent. Exclusion Criteria: 1. Emergency or salvage procedure 2. Patients with end stage renal failure defined as an estimated Glomerular Filtration rate (eGFR) <15 mL/min/1.72 m2 calculated from the Modification of Diet in Renal Disease equation, or patients who are on long-term haemodialysis or have undergone renal transplantation. 3. Patients who are prevented from having blood and blood products according to a system of beliefs (e.g. Jehovah's Witnesses). 4. Patients with a pre-existing sepsis or organ injury defined as documented sepsis, acute kidney injury, acute lung injury, myocardial infarction, low cardiac output, liver injury, stroke or pancreatitis within 5 days of surgery. 5. Pregnancy. 6. Patients who are participating in another interventional clinical study. 7. Patients requiring irradiated blood. 8. Sickle cell anaemia. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Department of Cardiovascular Sciences | Leicester | Leicestershire |
Lead Sponsor | Collaborator |
---|---|
University of Leicester | British Heart Foundation, National Health Service, United Kingdom, Zimmer Biomet |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Acute lung injury | To inform the design of a subsequent efficacy trial | from date of randomisation through to study completion (3 months) | |
Other | Acute kidney injury | To inform the design of a subsequent efficacy trial | from date of randomisation through to study completion (3 months) | |
Other | Low cardiac output | To inform the design of a subsequent efficacy trial | from date of randomisation through to study completion (3 months) | |
Other | Acute brain injury | To inform the design of a subsequent efficacy trial | from date of randomisation through to study completion (3 months) | |
Other | Acute liver or gut injury | To inform the design of a subsequent efficacy trial | from date of randomisation through to study completion (3 months) | |
Other | Sepsis | To inform the design of a subsequent efficacy trial | from date of randomisation through to study completion (3 months) | |
Other | Organ injury, sepsis or death (a composite of sepsis, acute kidney injury, acute lung injury, acute brain injury, low cardiac output syndrome, gut or liver injury or death) | To inform the design of a subsequent efficacy trial | from date of randomisation through to study completion (3 months) | |
Other | Endothelial function, tissue hypoxia and p50 of circulating red cells | To be measured in a sub-study of mechanisms in 80 participants | baseline and 24 hours post-op | |
Other | Recipient platelet, monocyte and endothelial activation in whole blood as determined using flow cytometry | To be measured in a sub-study of mechanisms in 80 participants | baseline to 48 hours post-op | |
Other | Bronchial aspirate neutrophil and protein concentration | To be measured in a sub-study of mechanisms in 80 participants | 4-6 hours post-op | |
Other | free haem | To be measured in a sub-study of mechanisms in 80 participants | baseline to 96 hours post-op | |
Other | serum bilirubin | To be measured in a sub-study of mechanisms in 80 participants | baseline to 96 hours post-op | |
Other | transferrin saturation | To be measured in a sub-study of mechanisms in 80 participants | baseline to 96 hours post-op | |
Other | non-transferrin bound iron | To be measured in a sub-study of mechanisms in 80 participants | baseline to 96 hours post-op | |
Other | hepcidin | To be measured in a sub-study of mechanisms in 80 participants | baseline to 96 hours post-op | |
Other | pulmonary leucocyte haem oxygenase-1 expression | To be measured in a sub-study of mechanisms in 80 participants | baseline to 96 hours post-op | |
Other | serum protein carbonylation and lipid peroxidation | To be measured in a sub-study of mechanisms in 80 participants | baseline to 96 hours post-op | |
Primary | Renal injury | measurement of serum creatinine | baseline to 96 hours postoperatively | |
Primary | Myocardial injury | measurement of serum troponin | baseline to 72 hours postoperatively | |
Secondary | Protocol compliance measured through protocol deviations | protocol deviations will be aggregated based on pre-defined codes | from date of randomisation through to study completion (3 months) | |
Secondary | Recruitment | measured through recruitment figures | from date of randomisation through to study completion (3 months) | |
Secondary | Event rates | measured through serious adverse event (SAE)/ serious unexpected serious adverse reaction (SUSAR) reporting | from date of randomisation through to study completion (3 months) | |
Secondary | Blinding | measured through protocol deviations | from date of randomisation through to study completion (3 months) | |
Secondary | Urinary neutrophil gelatinase associated lipocalin (NGAL) | measured through urine collection | baseline to 48 hours postoperatively | |
Secondary | Serum creatinine | measured to assess renal function | at 6 weeks postoperatively | |
Secondary | eGFR | measured to assess renal function | at 6 weeks postoperatively | |
Secondary | Sepsis-related Organ Failure Assessment (SOFA) Score | Sepsis will be defined as suspected or documented infection and an acute change in total SOFA score =2 points consequent to the infection. | at baseline, 24, 48, 72 and 96 hours postoperatively | |
Secondary | Arterial serum lactate | 24 hours postoperatively until time of resolution of hyperlactataemia | ||
Secondary | Lung injury | arterial alveolar oxygen ratios | baseline to 96 hours postoperatively | |
Secondary | GI tract injury | serum amylase and liver function tests | at baseline, 24, 48, 72, and 96 hours postoperatively | |
Secondary | Transfusion reactions | measured as part of standard care to assess transfusion safety | from date of randomisation through to study completion (3 months) | |
Secondary | Age of each unit of red cells transfused | day of operation | ||
Secondary | Postoperative blood loss, transfusion of red cell and non-red cell allogenic blood components | day of operation | ||
Secondary | Adverse events other than those included in the primary endpoint | from date of randomisation through to study completion (3 months) | ||
Secondary | Length of ICU and hospital stay | from date of randomisation through to study completion (3 months) |
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