{"id":"octaplaslg","safety":{"commonSideEffects":[{"rate":null,"effect":"Thromboembolic events (venous thromboembolism)"},{"rate":null,"effect":"Transfusion-related acute lung injury (TRALI)"},{"rate":null,"effect":"Allergic/anaphylactic reactions"},{"rate":null,"effect":"Hypervolemia/fluid overload"},{"rate":null,"effect":"Infection (viral/bacterial)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"OctaplasLG® is a solvent/detergent-treated pooled human plasma containing all major coagulation factors (I, II, V, VII, VIII, IX, X, XI, XII), fibrinolytic factors, and natural anticoagulants. It is used to rapidly correct multiple factor deficiencies in acute bleeding or perioperative settings where specific factor replacement is unavailable or impractical. The solvent/detergent treatment inactivates enveloped viruses, reducing transfusion-transmitted infection risk.","oneSentence":"OctaplasLG® is a liquid plasma product that replaces multiple coagulation factors and other plasma proteins to restore hemostatic function in patients with coagulation deficiencies.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:58:03.798Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute bleeding or perioperative bleeding in patients with multiple coagulation factor deficiencies"},{"name":"Reversal of vitamin K antagonist (warfarin) anticoagulation in emergency settings"},{"name":"Massive transfusion protocols"}]},"trialDetails":[{"nctId":"NCT04580563","phase":"NA","title":"Study Assessing Efficacy of Plasmatherapy in Septic Shock-induced Coagulopathy: Feasibility Study","status":"COMPLETED","sponsor":"University Hospital, Strasbourg, France","startDate":"2020-10-22","conditions":"Septic Shock, Coagulopathy, Disseminated Intravascular Coagulation","enrollment":60},{"nctId":"NCT03092245","phase":"PHASE2","title":"Vasculopathic Injury and Plasma as Endothelial Rescue in Septic Shock (SHOCK) Trial","status":"COMPLETED","sponsor":"Rigshospitalet, Denmark","startDate":"2017-04-18","conditions":"Septic Shock","enrollment":44},{"nctId":"NCT03369314","phase":"","title":"Observational Study of the Use of octaplasLG®.","status":"COMPLETED","sponsor":"Octapharma","startDate":"2018-03-02","conditions":"Thrombotic Thrombocytopenic Purpura","enrollment":263},{"nctId":"NCT02875236","phase":"PHASE4","title":"Vasculopathic Injury and Plasma as Endothelial Rescue in Septic Shock Trial. VIPER-Sepsis (EudraCT no. 2016-000707-81)","status":"TERMINATED","sponsor":"Rigshospitalet, Denmark","startDate":"2016-09-01","conditions":"Septic Shock","enrollment":5},{"nctId":"NCT02253082","phase":"PHASE4","title":"Vasculopathic Injury and Plasma as Endothelial Rescue - OCTAplas Trial (EudraCT no. 2014-000452-28)","status":"COMPLETED","sponsor":"Rigshospitalet, Denmark","startDate":"2014-11","conditions":"Aortic Aneurysm, Thoracic, Endothelial Dysfunction","enrollment":44}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":29,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Octaplas","OctaplasLG"],"phase":"marketed","status":"active","brandName":"OctaplasLG®","genericName":"OctaplasLG®","companyName":"Rigshospitalet, Denmark","companyId":"rigshospitalet-denmark","modality":"Small molecule","firstApprovalDate":"","aiSummary":"OctaplasLG is a treatment being studied for various conditions, including septic shock, aortic aneurysm, endothelial dysfunction, thrombotic thrombocytopenic purpura, and coagulopathy. It is being compared to Ringer-Acetate in clinical trials, such as the Vasculopathic Injury and Plasma as Endothelial Rescue in Septic Shock (SHOCK) Trial, to evaluate its efficacy and safety.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}