INDICATION AND USAGE
Rejuvesol
Solution is intended only to be used as an in vitro processing solution for the rejuvenation of a unit of RBC. RBC may be rejuvenated after storage in CPD (non-leukocyte reduced), CPDA-1, (non-leukocyte reduced), CPD/ADSOL
(CPD/AS-1 leukocyte reduced), or CP2D/Nutricel
(CP2D/AS-3, leukocyte reduced). The final concentration of ATP and 2,3-DPG achieved after rejuvenation will vary depending on the number of days of liquid storage at 1-6 C prior to rejuvenation.
NOTE: For simplicity, RBC stored in CPD (non-leukocyte reduced), CPDA-1 (non-leukocyte reduced), CPD/ADSOL
(CPD/AS-1 leukocyte reduced), CP2D/Nutricel
(CP2D/AS-3, leukocyte reduced) are referred to hereafter as CPD, CPDA-1, CPD/AS-1, and CP2D/AS-3, respectively. Citra Labs, LLC, recommends that rejuvenation of RBC be performed after 14 days or longer of liquid storage. RBC (CPD, CPDA-1, CPD/AS-1, and CP2D/AS-3) rejuvenated before 6 days of storage may achieve 2,3-DPG levels in excess of 2 times normal and ATP levels in excess of 1.5 times normal
5,6 (See
Warning and Contraindications).
Rejuvenation of CPD or CPDA-1 RBC for Immediate use or for Cryopreservation
RBC which have been collected and stored in CPD or CPDA-1 anticoagulant may be rejuvenated up to three days after the expiration date of the RBC, as long as storage at 1-6 C is not interrupted.
3,4 After rejuvenation, RBC (CPD and CPDA-1) must be either washed and stored at 1-6 C for up to 24 hours prior to transfusion or glycerolized and frozen at 80 C (below 65 C). Red Blood Cells Frozen Rejuvenated which were collected and stored in CPD or CPDA-1 may be stored frozen up to 10 years.
10
When RBC are rejuvenated after maximum liquid storage, i.e., CPD RBC at 24 days or CPDA-1 RBC at 38 days, the concentrations of 2,3-DPG and ATP increase typically to above normal.
1,3-5,6
CAUTION: RBC collected in CPD or CPDA-1 cannot be leukocyte reduced prior to rejuvenation.
Rejuvenation of CPD/AS-1 RBC or CP2D/AS-3
Rejuvesol
Solution has not been approved for the rejuvenation of RBC stored in any additive systems other than AS-1 or AS-3. RBC stored in CPD/AS-1 or CP2D/AS-3 at 1-6 C may be rejuvenated up to, but not exceeding, 42 days of storage as long as storage at 1-6 C is not interrupted. Rejuvenated CPD/AS-1 RBC must be either washed and stored at 1-6 C for up to 24 hours prior to transfusion or glycerolized and frozen at 80 C (below 65 C). Red Blood Cells Frozen Rejuvenated which were collected and stored in CPD/AS-1 may be stored for up to 3 years. Rejuvenated CP2D/AS-3 RBC must be washed and stored at 1-6 C for up to 24 hours prior to transfusion. Unlike rejuvenated CPD, CPDA-1, CPD/AS-1 RBC, and CP2D/AS-3, rejuvenated RBC collected and stored in any other anticoagulant/additive solution combination have not been approved to be immediately washed and transfused or for cryopreservation.
Rejuvenation of CPD/AS-1 RBC for Cryopreservation
When CPD/AS-1 RBC are rejuvenated at 42 days of liquid storage, frozen, deglycerolized, and stored for 24 hours, the concentration of 2,3-DPG and ATP increases to above normal. In a limited study, the average 24 hour post-transfusion survival value of these cells was statistically higher than the reported
12 survival value of CPD/AS-1 red blood cell concentrates which are stored for 42 days prior to transfusion. The "dose" may be equivalent for a CPD/AS-1 RBC whether the unit is stored for 42 days prior to transfusion or stored for 42 days, rejuvenated, frozen, deglycerolized, and stored for 24 hours prior to transfusion. Unlike rejuvenated CPD/AS-1 RBC, rejuvenated RBC (CP2D/AS-3) has not been approved for cryopreservation.
Rejuvenation of CPD/AS-1 RBC or CP2D/AS-3 for Immediate Use
When CPD/AS-1 RBC are rejuvenated at 42 days of liquid storage, washed, and stored for 24 hours, the concentration of ATP increases to day 0 values. For 2,3-DPG rejuvenation of RBCs stored in CPD/AS-1 for 42 days,
the range of 2,3 DPG relative to day 0 value was 46%-172% with a mean of 98%
29%.
For 66% of the RBC units (44/67, 33/33 in Site A and 11/34 in Site B) the concentration of 2,3-DPG reached at least 80% of the day 0 value.
When CP2D/AS-3 RBC are rejuvenated at 42 days of liquid storage, washed, and stored for 24 hours, the concentration of ATP increases to day 0 values. For 2,3-DPG rejuvenation of RBCs stored in CPD/AS-1 for 42 days,
the range of 2,3 DPG relative to day 0 value was 48%-150% with a mean of 96%
23%.
For 76% of the RBC units (52/68, 30/35 in Site A and 22/33 in Site B) the concentration of 2,3-DPG reached at least 80% of the day 0 value.