Quality comparison of Red Blood Cell Concentrates between DEHT-PAGGSM bags and DEHT-SAGM bags – 49 days storage study

Authors
A. Lotens¹, T. Najdovski¹, N. Valensart¹, N. Cellier¹, C. Sumian², Q. Brebant², C. Naegelen³, C.Cretenet³, N.Marpaux³

¹Blood Service, Belgian Red Cross, Namur, Belgium
²MacoPharma, Tourcoing, France
³EFS Bourgogne Franche Comté, Besançon, France

Background and Aim :

→The plasticizer di(2-ethylhexyl)-phthalate (DEHP) is a common component in blood collection systems.
→Exposure to DEHP is raising concern on about its potential carcinogenicity and reprotoxicity. Therefore, the DEHP will be banned following the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation in 2030.
→DEHP is also known for its protector effect and stabilizer of RBC membrane during their storage.
→ A new combination of DEHP-free plasticizer/storage solution is tested to maintain the same current quality of RBC

AIM: Assess the RBC quality stored in di(2-ethylhexyl)-terephthalate DEHT (Transfufol DEHT 3126 from RENOLIT Nederland B.V.)/PAGGSM (Phosphate Adenine Glucose
Guanosine Saline Mannitol) compared to RBC in DEHT(Transfufol DEHT 3126 from RENOLIT NederlandB.V.)/SAGM (Saline Adenine Glucose Mannitol) until 49 storage days.

Study design and methods :

→ Half of bags were processed in SFS, the other part in EFS
→ Storage study until 49 days
→ Quality parameters were tested each week

Results

There is a significant difference on haemolysis from day 21 between SAGM and PAGGSM and a significant difference for ATP from day 35. The T&B/PAGGSM kit is the combination giving the lowest haemolysis rate (p<0.001). The two storage solutions have the same behaviour for the pH, glucose, lactate and potassium.

Conclusion

The storage solution PAGGSM allows to counterbalance the RBC stability loss due to the plasticizer change. This new association DEHT/PAGGSM ables to keep haemolysis conformity until 49 days.