European Authorities Approve Lyophilized S/D Treated Plasma OctaplasLG® for Pre-Hospital Transfusion
LACHEN, Switzerland–(BUSINESS WIRE)– Octapharma AG today announced that European medical authorities have approved the lyophilised presentation of the well-established octaplasLG® – pharmaceutically-licensed S/D treated plasma for transfusion. The line extension, which will be marketed in Europe as a powder and solvent for solution for infusion, offers new and potentially life-saving treatment options in pre-hospital and emergency settings.
“The European authorization of octaplasLG® powder continues Octapharma’s ongoing commitment to help prevent uncontrolled haemorrhage associated with trauma, which accounts for 30%-50% of all deaths in the first 24 hours”1-5, says Dr. Oliver Hegener, Vice President IBU Critical Care.
Trauma results in 4.4 million deaths worldwide annually6, with uncontrolled bleeding being the major cause of potentially preventable death. Trauma-induced coagulopathy (TIC) is an early abnormal response characterised by hypocoagulation, in addition to acute blood loss, shock, hypothermia and metabolic acidosis, that begins soon after injury. Early – pre-hospital – administration of plasma has been shown to increase survival, compared with crystalloids, when pre-hospital transport was longer than 20 minutes.7
Until now, access to early plasma transfusion was limited by logistic hurdles as well as a lack of available transfusion medicine in the pre-hospital setting for both for civilian and military patients.
“octaplasLG® powder, an AB universal plasma, can be stored at room temperature and reconstituted within minutes, representing a potentially lifesaving treatment option in emergency situations and in locations with limited frozen storage facilities and cold chain infrastructure required for regular FFP,” explains Dr. Hegener.
Pharmaceutical grade human plasma for infusion with standardised quality and unique pathogen safety profiles due to Octapharma’s integrated pathogen elimination/inactivation concept. The standardised content is achieved by pooling between 630 and 1520 single plasma units from multiple carefully screened donors. Safety measures present during manufacturing include: Donor screening, immunoneutralisation, Solvent/detergent treatment and Ligand affinity chromatography for prion reduction.
The product is approved for:
- Complex deficiencies of coagulation factors such as coagulopathy due to severe hepatic failure or massive transfusion.
- Substitution therapy in coagulation factor deficiencies, when a specific coagulation factor concentrate (e.g., factor V or factor XI) is not available for use or in emergency situations when a precise laboratory diagnosis is not possible.
- Rapid reversal of the effects of oral anticoagulants (coumarin or indanedione type) when a prothrombin complex concentrate is not available for use or administration of vitamin K is insufficient due to impaired liver function or in emergency situations.
- Potentially dangerous haemorrhages during fibrinolytic therapy, using e.g., tissue plasminogen activators, in patients who fail to respond to conventional measures.
- Therapeutic plasma exchange procedures, including those in thrombotic thrombocytopenic purpura (TTP).
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.
Octapharma employs more than 11,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Haematology, and Critical Care.
Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centres across Europe and the US.
1. Bosch F, Angele MK, Chaudry IH. Gender differences in trauma, shock and sepsis. Mil Med Res. 2018;5(1):35.
2. Iapichino GE, Ponschab M, Cadamuro J, et al. Concentrated lyophilized plasma used for reconstitution of whole blood leads to higher coagulation factor activity, but unchanged thrombin potential compared with fresh-frozen plasma. Transfusion. 2017;57(7):1763-71.
3. Nguyen C, Bordes J, Cungi PJ, et al. Use of French lyophilized plasma transfusion in severe trauma patients is associated with an early plasma transfusion and early transfusion ratio improvement. J Trauma Acute Care Surg. 2018;84(5):780-5.
4. Moore EE, Moore HB, Kornblith LZ, et al. Trauma-induced coagulopathy. Nat Rev Dis Primers. 2021;7(1):30.
5. Johansson PI, Sorensen AM, Perner A, et al. Disseminated intravascular coagulation or acute coagulopathy of trauma shock early after trauma? An observational study. Crit Care. 2011;15(6): R272.
6. World Health Organization. Injuries and violence. 19 March 2021. Available at: https://www.who.int/news-room/fact-sheets/detail/injuries-and-violence. Last accessed January 2023.
7. Pusateri AE, Moore EE, Moore HB, et al. Association of Prehospital Plasma Transfusion With Survival in Trauma Patients With Hemorrhagic Shock When Transport Times Are Longer Than 20 Minutes: A Post Hoc Analysis of the PAMPer and COMBAT Clinical Trials. JAMA Surg. 2020;155(2): e195085.
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