Creating a plasma coordination center to support COVID-19 outpatient trials across a national network of hospital blood banks.

Introduction: In response to the COVID-19 pandemic, we rapidly implemented a plasma coordination center, within two months, to support transfusion for two outpatient randomized controlled trials. The center design was based on an investigational drug services model and a Food and Drug Administration-compliant database to manage blood product inventory and trial safety.

Methods: A core investigational team adapted a cloud-based platform to randomize patient assignments and track inventory distribution of control plasma and high-titer COVID-19 convalescent plasma of different blood groups from 29 donor collection centers directly to blood banks serving 26 transfusion sites.

Long-term Experience with Rapid Screening for Platelet Bacterial Contamination in a High-volume Transfusion Service.

Bacterial sepsis after platelet transfusion is a major cause of transfusion-transmitted infections in the US. The Food and Drug Administration (FDA) recommends performing quality control for platelet bacterial detection on days 4 and 5 before platelet transfusion. We assessed the feasibility of implementing the Pan Genera Detection (PGD) test, an FDA-approved immunoassay for platelet bacterial detection, for the primary and secondary bacterial screening of platelet units in a high-volume setting.

Evaluation of a heparin monitoring protocol for extracorporeal membrane oxygenation and review of the literature.

Background: Bleeding complications are common with extracorporeal membrane oxygenation (ECMO). We investigated whether a heparin monitoring protocol using activated partial thromboplastin time (aPTT) and thromboelastography (TEG) affected clinical outcomes.

Methods: This retrospective chart review stratified cohorts by study interval: pre-protocol (January 2016-March 2017) or post-protocol (March 2017-December 2017).

Characteristics of thawed pooled cryoprecipitate stored at refrigerated temperature for 24 hours.

Background: The need for thawed cryoprecipitate is growing. However, according to current guidelines, the shelf-life of pooled thawed cryoprecipitate at room temperature is limited because of possible bacterial contamination and loss of clotting factor activity. Here we assessed microbial growth and retention of clotting activity in cryoprecipitate stored at 4 °C after thawing to see whether its shelf life could be safely extended.

An extremely rare splice site mutation in the gene encoding complement factor I in a patient with atypical hemolytic uremic syndrome.

Background: Atypical hemolytic uremic syndrome (aHUS) is a rare disease characterized by thrombocytopenia, microangiopathic hemolytic anemia, and acute kidney failure. The disease is difficult to diagnose due to its similarity with other hematologic disorders, such as thrombotic thrombocytopenic purpura (TTP). However, genetic mutations are found in 50-70% of patients with aHUS and can be useful in its diagnosis.

Plasma Exchange for Urgent Apixaban Reversal in a Case of Hemorrhagic Tamponade after Pacemaker Implantation.

We report the case of an 82-year-old man in whom hemorrhagic pericardial effusion occurred one week after pacemaker implantation, while he was taking apixaban. Few therapies exist for reversing the anti-Xa effect of apixaban. To reverse anticoagulation, our patient underwent plasma exchange, which facilitated pericardiocentesis and prevented possible surgical intervention.

Analytical performance evaluation of ADVIA Chemistry Carbamazepine_2 assay: minimal cross-reactivity with carbamazepine 10, 11-epoxide and none with hydroxyzine or cetirizine.

Carbamazepine is an anticonvulsant requiring routine therapeutic drug monitoring. Recently, Siemens Healthcare Diagnostic Division released a new carbamazepine assay: ADVIA Chemistry Carbamazepine_2 (Carbamazepine_2) for application on ADVIA analyzers. We evaluated the analytical performance of this assay as well as its potential cross-reactivities with carbamazepine 10, 11-epoxide, hydroxyzine, and cetirizine.

Interaction of white and pink grapefruit juice with acetaminophen (paracetamol) in vivo in mice.

Grapefruit juice increases bioavailability of a number of drugs because of inhibition of the P-glycoprotein pump and inhibition of intestinal cytochrome P450 3A4 enzyme. However, interaction between acetaminophen (also known as paracetamol in many parts of the world) and grapefruit juice has never been reported. The interaction of grapefruit juice with acetaminophen was examined in an in vivo mouse model.

Rapid detection of oleander poisoning by Digoxin III, a new Digoxin assay: impact on serum Digoxin measurement.

We studied the potential for detecting oleander with a new immunoassay (Digoxin III, Abbott Laboratories, Abbott Park, IL) by comparing results with those from the fluorescence polarization immunoassay (FPIA) and Digoxin II assay (Abbott). In aliquots of drug-free serum pools supplemented with pure oleandrin or oleander extract, we observed apparent digoxin values using all 3 immunoassays, but values obtained by the Digoxin III were higher than obtained by the other assays. We also observed significant apparent digoxin values in vivo in serum samples of mice 1 and 2 hours after feeding oleander extract.

Effect of Chinese medicines Chan Su and Lu-Shen-Wan on serum digoxin measurement by Digoxin III, a new digoxin immunoassay.

Chan Su and Lu-Shen-Wan are Chinese medicines that crossreact with digoxin immunoassays. Recently, Abbott Laboratories released a new digoxin immunoassay, Digoxin III. We studied potential interference of Chan Su and Lu-Shen-Wan with the Digoxin III assay by comparing results obtained by using Digoxin II and fluorescence polarization immunoassay, also manufactured by Abbott Laboratories.

Effect of Brazilian, Indian, Siberian, Asian, and North American ginseng on serum digoxin measurement by immunoassays and binding of digoxin-like immunoreactive components of ginseng with Fab fragment of antidigoxin antibody (Digibind).

We compared Brazilian, Indian, Siberian, Asian, and North American ginseng for potential interference with 3 digoxin immunoassays: fluorescence polarization (FPIA), microparticle enzyme (MEIA), and Tina-quant (Roche Diagnostics, Indianapolis, IN). We supplemented aliquots of a drug-free serum pool with ginseng extracts representing expected in vivo concentrations and overdose. We observed apparent digoxin-like immunoreactivity with FPIA, modest immunoreactivity with MEIA, and no apparent digoxin immunoreactivity with the Tina-quant with all ginsengs except Brazilian, which showed no immunoreactivity with any assay.