Multi-center BLood STorage Trial Protocol (Multi-BLaST)

Study ID
STU 062010-082

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Cari Stebbins
214-648-7609
cari.stebbins@utsouthwestern.edu

Principal Investigator
Joseph Minei

Summary

This will be a prospective, randomized, double-blinded study. Three simultaneous comparisons will be conducted in parallel: frozen red blood cells (RBCs) versus newer packed red blood cells (PRBCs), frozen RBCs versus standard age PRBC, and standard age PRBC versus newer PRBC. Frozen RBCs will be prepared from younger PRBC units utilizing well-described techniques. units of frozen RBCs will be thawed, deglycerolized, and prepared for transfusion utilizing the aCP 215 (Haemontetics Corporation, Braintree, Ma). Frozen RBCs will be obtained from the armed Services Blood Program. This will be stored in a -80[Degrees]C freezer within the Blood Bank at each clinical site.

Patient Population
Patients admitted to the trauma service at each clinical site will be candidates. Patients with a minimal injury Severity Scale score (iSS) of 4 for whom a red blood cell transfusion has been ordered will be eligible. The iSS is the standard scoring system used to grade injury. a score of [Less Than] 9 is considered a minor injury. a score of [Greater Than]/[?]9 and [Less Than]16 is considered a moderate injury. a score [Greater Than]/[?] 16 is considered a severe injury. By requiring a score of at least 4, the study is minimizing the number of patients that will be screened with little likelihood of transfusion need. also, this is a study of injured patients and response to transfusion, by requiring a score of at least 4 the patients will have sustained a measurable injury burden. Patients will be randomized to receive newer PRBCs (?14 days old), standard age PRBCs ([Greater Than]14 days old), or frozen RBCs throughout their hospital stay. Consent from the patient or from a legal representative (LaR) prior to the transfusion of the first unit will be required for admission into the study. This will exclude patients who require emergent interventions in whom consent is unobtainable. in order to avoid confounding results from mixing the study groups, cross over between blood groups will be an exclusion criteria. Therefore, patients who require massive transfusions ([Greater Than] 10 units PRBC transfused in a 24 hour period) will be excluded. in light of the fact that the Trauma service admits patients who are age 15 and older, those younger than 15 years of age will not be included. Pregnant patients will be excluded due to the known changes in the peripheral vasculature that occur during pregnancy.
The primary outcome is changes in tissue oxygen saturation as measured by near infrared spectroscopy (niRS) after transfusion compared to before transfusion. inSpectra makes the niRS device that has been widely studied in trauma patients and has been found to be an accurate measure of perfusion alterations associated with injury.

Participant Eligibility

Inclusion Criteria

* Patient admitted to the Trauma service

* Injury Severity Score (ISS > 4)

* Transfusion of PRBCs may be required during hospital stay

* Transfusion not emergently required

* Able to obtain consent from the patient or appropriate 3rd party prior to randomization