Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Red blood cell units stored <= 10 days · 1 trial · 2 indications
The follow-up MODS used to calculate 7-day ΔMODS from pre-op baseline was based on the worst value of each component of MODS observed through post-op day 7, hospital discharge, or death, whichever occurred first, even if a subject's worst values for different components occurred on different dates. Subjects who died during this time period were assigned the worst possible follow-up MODS score, 24 points, and each component of MODS was set at 4, which is the worst score. If a subject did not die during this time period but had at least one day where the Glasgow Coma Score couldn't be scored \[subject sedated; neurologic function not normal by pre-op history (prior stroke, tumor or trauma sequelae, cognitively challenged, behavioral disorder, etc.) or intra-op history, but currently unable to assess because of sedation\], then a post-op MODS score was set to missing and a 7-day ΔMODS was not computed. The total MODS score ranges from 0 (best possible) to 24 points (worst possible).
| Arm | Type | Description |
|---|---|---|
| Shorter-storage red blood cell units | ACTIVE_COMPARATOR | Red blood cell units stored \<= 10 days |
| Longer-storage red blood cell units | ACTIVE_COMPARATOR | Red blood cell units stored \>= 21 days |
| Name | Type | Description |
|---|---|---|
| Red blood cell units stored <= 10 days | BIOLOGICAL | Pre-storage leukoreduced red blood cell units stored \<=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations. |
| Red blood cell units stored >= 21 days | BIOLOGICAL | Pre-storage leukoreduced red blood cell units stored \>=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations. |
Inclusion Criteria: * \>= 12 years old * \>= 40 kg body weight * Scheduled complex cardiac surgery with planned use of median sternotomy. * Patients ≥ 18 years must have a Transfusion Risk Understanding Scoring Tool (TRUST) probability score ≥ 3 Exclusion Criteria: * Refusal of blood products * P...
Red blood cell units stored <= 10 days is an investigational intervention being studied for use in cardiac surgery, specifically in patients undergoing procedures that may require erythrocyte transfusion. It is currently in Phase 3 clinical development, with a completed trial evaluating its effects in this setting.
Red blood cell units stored <= 10 days is being developed by Elevance Health, Inc., a company traded under the ticker ELV. The developer is conducting clinical research on this intervention for cardiac surgery patients.
Red blood cell units stored <= 10 days is in Phase 3 clinical development. It is an investigational intervention, not yet approved, and is being evaluated for use in cardiac surgery. A Phase 3 trial has been completed as part of its clinical program.
Red blood cell units stored <= 10 days has one completed Phase 3 clinical trial, identified as NCT00991341, titled 'Red Cell Storage Duration Study'. This trial enrolled 1481 participants in the United States and studied the intervention in patients with cardiac surgery and erythrocyte transfusion.
Red blood cell units stored <= 10 days refers to red blood cell units that have been stored for a duration of 10 days or less, which is considered fresher compared to longer storage periods. It is not a brand name but a description of the storage duration of the blood product.