Focus:Use of S303 RBCs in Patients With Acute Anemia
Conditions
Brief summary
The clinical study will assess the in-vitro characteristics of red blood cells (RBCs) per the European Union (EU) criteria for leukocyte depleted RBCs in additive solution and evaluate the safety and efficacy of S-303 treated RBCs in a patient population requiring RBC transfusion support for acute anemia.
Interventions
BIOLOGICALS-303 Red Blood Cells (RBCs) - Test
BIOLOGICALConventional, untreated red blood cells (RBCs) - Control
Sponsors
Cerus Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years, of either gender. 2. Must be willing to use an acceptable form of contraceptive while on study (as approved by the Investigator or designee) 3. Must be readily available by telephone 4. Must provide an informed consent for study participation and have signed an ethics committee (EC)-approved informed consent 5. Must have a negative cross match to S 303 red blood cells (RBCs) at study entry 6. Must have a blood type of either A+ or O+ 7. Patients must have a likelihood of receiving a transfusion as determined by the Investigator OR a Transfusion Risk Understanding Screening Tool (TRUST) Score of ≥3 at study entry 8. Must be scheduled to receive one of the following operative procedures: * Coronary artery bypass graft only, first procedure * Valve repair or replacement only, first procedure * A combination of first time Coronary Artery Bypass Graft (CABG) and valve repair or replacement After consultation with the Medical Monitor, provision can be made to enroll patients who may meet these general criteria but whose surgical procedure is not precisely described in the above categories. Such patients will be classified as other with their explicit condition reported with other study data.
Exclusion criteria
1. A positive pregnancy test result 2. Inability of patient to comply with the protocol in the opinion of the Investigator or attending physician 3. Breast-feeding of an infant or child 4. Active autoimmune hemolytic anemia, or a positive Direct Antiglobulin Test (DAT) result 5. Treatment with any medication that is known to adversely affect red blood cell viability 6. Emergent or salvage surgical status at the time of surgery defined as follows: * Presence of ongoing ischemia including angina at rest despite maximal medical therapy * Acute evolving myocardial infarction within 24 hours before surgery * Pulmonary edema requiring intubation * Presence of shock or hemodynamic instability with or without circulatory support * Systolic blood pressure \< 80 mm Hg and/or Cardiac Index \< 1.8 despite medical intervention (intravenous inotropes or similar pharmacologic agents) * Cardiopulmonary resuscitation in the 24 hours prior to surgery or anesthesia induction * Requiring an intra-aortic balloon pump or ventricular assist device 7. Participation in any one of the following types of clinical studies either concurrently or within the previous 28 days: investigational blood products, pharmacologic agents or imaging materials, including dyes, investigational surgical techniques, or devices. Studies of nutrition, psychology, or socioeconomic issues are not grounds for exclusion 8. Current diagnosis of either chronic or acute renal failure (requiring dialysis) or a serum creatinine greater than or equal to 1.8 mg/dL within 30 days prior to the start of surgery 9. Current diagnosis of either chronic or acute hepatic insufficiency or a total serum bilirubin greater than or equal to 2.0 mg/dL within 30 days prior to the start of surgery 10. Pre-existing RBC antibody that may make the provision of compatible study red blood cell (RBC) components difficult 11. Patients requiring plasma removal or irradiation of the RBC 12. Patients with prior history of severe allergic transfusion reactions 13. A positive cross match to S 303 treated RBC \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint - mean hemoglobin content | Day 2 | The mean hemoglobin content per red blood cell (RBC) component compared between the treatment groups |
| Primary Safety Endpoint - Adverse events | 90 days | The frequency of adverse events (related and unrelated to study RBC components) will be compared between the treatment groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Efficacy Endpoint | Day 35 | Proportion of RBC components that have adenosine-5'-triphosphate (ATP) levels of greater than 2 μmol/L |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Endpoint - incidence of renal insufficiency | Daily on days 0 through 6 | Incidence of renal insufficiency, indicated by serum creatinine level \>2 mg/dL WITH at least a 50% increase from pre-operative baseline OR a new requirement for therapy to treat renal insufficiency (dialysis) |
| Exploratory Endpoint - incidence of hepatic insufficiency | Daily on days 0 through 6 | Incidence of hepatic insufficiency, indicated by total bilirubin that is \>2 times the upper limit of normal AND represents at least a 50% increase from the preoperative baseline |
| Exploratory endpoint - Cardiopulmonary function | Day 7 and 13 | Cardiopulmonary function at the time of first ambulation and at the time of discharge, as measured by a standardized 6 Minute Walk Test (6MWT) |
Countries
Germany
Outcome results
None listed