Incidence and risk factors for intravenous immunoglobulin-related hemolysis: A systematic review of clinical trial and real-world populations.

Background: Severe hemolysis rarely occurs in patients receiving intravenous immunoglobulin (IVIG) therapy. A systematic review was performed to assess the incidence of IVIG-related hemolysis and the impact of patient and product risk factors.

Study Design And Methods: A systematic literature search for terms related to "IVIG products", "hemolysis," and "adverse events" was conducted in Embase for articles published between January 1, 2015, and May 31, 2021.

Isoagglutinin reduction by a dedicated immunoaffinity chromatography step in the manufacturing process of human immunoglobulin products.

Background: The passive transfer of antibodies specific to blood groups A and B (also called isoagglutinins) contained in immunoglobulin (Ig)G products for intravenous administration (IVIG) is believed to be largely responsible for rare but sometimes serious IVIG-related hemolytic events. We present in this work a modification of the manufacturing process of Privigen-a 10% l-proline-stabilized IVIG product-that allows extensive reduction of isoagglutinin concentrations in the final product.

Study Design And Methods: An additional immunoaffinity chromatography (IAC) step was introduced toward the end of the manufacturing process of Privigen.

Effects of the manufacturing process on the anti-A isoagglutinin titers in intravenous immunoglobulin products.

Background: The first intravenous immunoglobulin G (IVIG) preparations for clinical use were produced from human plasma by Cohn-like fractionation processes. To achieve higher purity and yield, chromatography-based processes were developed. Using two products as examples, we compare the capacity of these two manufacturing processes to reduce the levels of anti-A and anti-B isoagglutinins in IVIG, which are believed to be responsible for rare hemolytic adverse events.

Perioperative kinetics of the nitric oxide derivatives nitrite/nitrate during orthotopic liver transplantation.

Nitric oxide (NO) is an important mediator in ischemia-reperfusion injury during human orthotopic liver transplantation (OLT). The perioperative kinetics of nitrite/nitrate plasma levels in 25 patients undergoing uncomplicated OLT were studied. A uniform pattern with significant increases of nitrite/nitrate levels immediately after reperfusion was seen in all patients, followed by a decrease to pretransplant levels within 24h.

Influence of inhaled nitric oxide on plasma nitrate concentrations in patients with adult respiratory distress syndrome and sepsis: results of a pilot study.

Study Objective: To measure plasma nitrate concentrations after inhalation of nitric oxide for treatment of adult respiratory distress syndrome (ARDS) and sepsis.

Design: Prospective pilot study.

Setting: Intensive care unit at a university-affiliated hospital.

Single-dose pharmacokinetics of ofloxacin during continuous venovenous hemofiltration in critical care patients.

Background: Ofloxacin is a quinolone administered to patients with severe infections. Pharmacokinetic data on ofloxacin in critically ill patients on renal replacement therapy are sparse and conflicting.

Methods: Eight patients with anuric acute renal failure were administered 400 mg of ofloxacin intravenously.