Frozen And Deglycerolized Red Blood Cells - United States Army
Joint Trauma SystemFrozen and DeglycerolizedRed Blood CellsPart of the Joint Trauma System (JTS) Clinical Practice Guideline (CPG) Training Series1
PurposeThis CPG provides evidence–based guidelines forthe use of frozen deglycerolized red blood cells(DRBCs).This presentation is based on the JTS Frozen and Deglycerolized Red Blood Cells CPG,11 Jul 2016 (ID: 26). It is a high-level review. Please refer to the complete CPG fordetailed instructions. Information contained in this presentation is only a guidelineand not a substitute for clinical judgment.2
Agenda Summary Background Clinical Use of DRBCs Performance Improvement (PI) Monitoring References Appendices Contributors3
SummaryPreviously frozen deglycerolized red blood cells(DRBCs) can be used interchangeably withliquid-stored red blood cells in transfusions.4
Key Principles of CPG References Appendices5
Background DRBCs are derived from 450-500 mL of whole blood through amultistep process. The red blood cell components are separated and frozen in acryoprotectant (40% w/v glycerol.) The frozen red blood cells (RBCs) are stored at minus 65 C or colderfor up to 10 years. Once thawed for use, the blood is washed to deglycerolize creatingthe DRBCs. Frozen blood has been in use since 1956 and is FDA approved fortransfusion for up to 14 days when processed on theHaemonetics Automated Cell Processor ACP215.6
Background FDA-approved DRBCs are typically used at Role 2 orhigher medical treatment facilities, but can be used inthe prehospital setting. No statistically significant difference in outcomes ortransfusion-related complications have been identified.7
BackgroundMassive Transfusion with DRBC compared to Standard Massive TransfusionOverall MortalityComplicationsTransfusion ReactionCoagulopathyp value0.241p valueN/A0.27163 cases/63 controls matched for age, ISS, total RBC within 24 hours, patient category, genderNo cases in sample63 cases/63 controls matched for age, ISS, total RBC within 24 hours, patient category, gender, initialbase deficit, initial temperature, initial INR60 cases/60 controls matched for age, ISS, total RBC within 24 hours, patient category, gender,Renal Failure0.57extremity injury23 cases/23 controls matched for age, ISS, total RBC within 24 hours, patient category, gender,DVT0.753extremity injuryRespiratory FailureN/ANo cases in sampleSixty-three patients in Afghanistan were identified between Jan 10 - Sep 11 as having a massive transfusion which included deglycerolizedblood (DRBC). A control population of 525 patients with non-DRBC massive transfusion from the same time period and theater was found inthe DoD Trauma Registry (DoDTR) to provide comparison of overall mortality.CONCLUSION: With the data available, there appears to be no statistical difference in mortality outcome in theater for patients receivingdeglycerolized blood (DRBC) as part of a massive transfusion when compared to patients receiving no DRBC as part of a massive transfusion.Additionally, there seems to be no significant difference between massive transfusions with DRBC and without DRBC in the development ofcomplications for transfusion reaction, coagulopathy, renal failure, deep vein thrombosis (DVT), or respiratory failure.Completed 23 March 20128
Clinical Use of DRBCs The primary indication for the use of DRBCs is to supplementliquid RBCs during surge periods of increased transfusionrequirements. DRBCs may be used in lieu of liquid-stored RBCs for all RBCtransfusion requirements including massive transfusions.9
Clinical Use of DRBCsEach unit of DRBCs: Should be considered equivalent to a fresh unit of RBCs. Have a 14-day shelf-life upon deglycerolization. Contain more than 80% of the RBCs present in the original unit of blood. Provides the same physiologic benefits as liquid RBCs. Carries the same expectation for post-transfusion survival as liquidstored RBCs. Contains significantly lower concentrations of proteins associated withnon-hemolytic transfusion reactions.10
Clinical Use of DRBCs Thawing and deglycerolization are time-consuming processes. Takes at least 35 minutes to thaw. Takes 60 minutes to deglycerolize one unit in the ACP215. In periods of predictable operational requirements, it may beprudent to pre-thaw and deglycerolize several units to avoid thepreparation delay. The physician may order use of DRBCs, but in practice the medicaltreatment facility will use DRBCs and liquid-stored RBCsinterchangeably.11
Clinical Use of DRBCsThe laboratory will establish and maintain a process to documentDRBC transfusions in a manner that will facilitate future evaluationof receipts. Documented items should include at least: Blood component identified Date of blood component received in frozen state Date of thaw/deglycerolization/additive process and resultingexpiration date Casualty identifiers Date of transfusion Transfusion indication Transfusion reaction/outcome12
PI Monitoring Intent (Expected Outcomes)All patients who receive DRBC transfusions have accurate documentation in themedical record of the quantity of transfused blood and any transfusion-relatedadverse events. Performance/Adherence MeasuresIn patients who were transfused DRBCs, there was accurate documentation in themedical record as to the quantity of blood transfused and any transfusion-relatedadverse events. Data Source Patient Record DoDTR CENTCOM blood bank logs Theater Medical Data Store13
References1. Emergency War Surgery Handbook, Fourth United States Revision, 2013, Borden Institute, US Army MedicalDepartment and School, Ft. Sam Houston, Texas.2. Glycerolization and deglycerolization of red blood cells in a closed system using the Haemonetics ACP215,Naval Blood Research Laboratory, C. Robert Valeri, http://www.nbrl.org/SOP/ACP215/ACP215All.html3. Hampton DA, Wiles C, Fabricant LJ, Kiraly L, Differding J, Underwood S, Le D, Watters J, Schreiber MA.Cryopreserved red blood cells are superior to standard liquid red blood cells. J Trauma Acute Care Surg.2014 Jul;77(1):20-7; discussion 26-7. PMID:249777504. Fabricant L, Kiraly L, Wiles C, Differding J, Underwood S, Deloughery T, Schreiber M. Cryopreserveddeglycerolized blood is safe and achieves superior tissue oxygenation compared with refrigerated red bloodcells: a prospective randomized pilot study. J Trauma Acute Care Surg. 2013 Feb;74(2):371-6; discussion3767. PMID:2335422714
Appendices Appendix A: Massive Transfusion with DRBC Comparedto Standard Massive Transfusion Appendix B: Additional Information Regarding OffLabel Uses in CPGs15
Contributors LTC Andrew Cap, MC, USA LTC Audra Taylor, MC, USA LTC John Badloe, MC, Netherlands LTC Jason Corley, MC, USA LTC Thomas Woolley, UK Heather Pidcoke, MD, PhD MAJ Nicolas Prat, MC, France LTC Michael Reade, MC, Australia COL (ret) Richard Gonzales, MC, USA COL Martin Schreiber LTC (ret) Wilbur Malloy, MC, USASlides: Maj Andrew Hall, MC, USAFPhotos are part of the JTS image library unlessotherwise noted.16
The red blood cell components are separated and frozen in a cryoprotectant (40% w/v glycerol.) The frozen red blood cells (RBCs) are stored at minus 65 C or colder for up to 10 years. Once thawed for use, the blood is washed to deglycerolize creating the DRBCs. Frozen blood has been in use since 1956 and is FDA approved for
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