The NBA is interested in relevant safety issues which arise in particular countries, and also instances of good practice. We monitor health issues in countries from which Australia’s visitors and immigrants come.
In Canada, Therapure Biopharma of Mississauga received $C 20 million contribution from the Federal Economic Development Agency for Southern Ontario’s Advanced Manufacturing Fund. Therapure has developed a proprietary technology called PlasmaCap Expanded Bed Adsorption15, which it says increases protein yields from plasma, separates them faster, and costs less. Nick Green, president and CEO of Therapure, said: “This investment, for which we thank the Government of Canada, will help us expand our scope and accelerate our growth in the plasma proteins industry. This expansion was a natural progression for Therapure after having established ourselves as a successful contract manufacturer of complicated biologics with additional expertise in plasma-derived proteins. We believe that our PlasmaCap EBA™ technology delivers the highest yields in the industry and will allow us to produce safe, quality, life-changing products for patients".
A biosafety level 4 lab in Musahimurayama, Tokyo, will be Japan’s first facility able to handle Ebola, joining around 40 labs worldwide. The upgrade of the National Institute of Infectious Diseases lab, built over 30 years ago, followed talks between the health minister and the local mayor to overcome local opposition.
Transylvania electronic music festival Untold in 2015 offered its potential audience free or discounted tickets in exchange for blood donations. In partnership with the National Institute of Blood Transfusion, donation centres were established in 41 Romanian cities during a ten day window in July.
In India, which experiences around 20,000 deaths annually from rabies, there is a shortage of human rabies immunoglobulin.
The Haemovigilance Programme of India (HvPI), launched in December 2012 by National Institute of Biologicals (NIB), reported 2303 adverse transfusion reaction reports during its first two and a half years of operation. Dr Surinder Singh, director, NIB says the Programme is confidential, independent, offers expert analysis through a Haemovigilance Advisory Committee, is systems oriented and is responsive. It aims to improve transfusion safety by identifying trends in adverse events, targeting areas for improved practice, and increasing awareness of transfusion hazards.
In Australia, a partnership between the Royal Flying Doctor Service, New South Wales Ambulance Service, The Western Local Health District and Pathology West- Dubbo will allow blood to be carried in RFDS aircraft for use in trauma cases.
A Californian study16 showed that haemophilia accounted for the largest share of the State’s expenditure on outpatient drugs for publicly insured children with serious chronic illnesses. A group led by Sonja Swenson of Stanford University wrote that their study "underscores the potential effect of new, expensive but [effective] pharmaceuticals on public insurance programs for children with chronic illness.” The study tracked 2010-2012 data from more than 34,300 patients under the age of 21. Antihaemophilic factor accounted for 41 per cent of pharmacy expenditure on children although children treated with antihaemophilic factor made up only 0.4 per cent of all the children in the study. Over the period of the study, the average per-child cost for antihaemophilic factor was about $US 1.3 million.
Two of Florida’s independent, nonprofit blood centers, OneBlood Inc. and The Blood Alliance Inc., merged and will carry the OneBlood brand. They said the merger will result in operational efficiencies, enhance donor outreach initiatives and further stabilize the blood supply, especially in times of natural disasters. The merged organisation will employ 2,400 people and serve over 210 hospitals in Florida, Georgia, Alabama and South Carolina.
Safety and patient blood management
We follow current issues in patient safety and achieving favourable patient outcomes.
Appropriate transfusion
A retrospective study 17of 3,721 patients from a tertiary care spine referral centre found that patients who received an allogeneic blood transfusion during lumbar spine surgery were at higher risk for surgical site infection, urinary tract infection and overall postoperative infections. No dose-response relationship was observed between any of the postoperative infection types and the number of units of blood transfused.
Researchers have found18that the clinical benefits of minimally invasive aortic valve replacement via lower hemi-sternotomy19 include decreased transfusion requirements, decreased ventilation times, and shorter ICU and hospital stays, without compromising short and long term survival compared with conventional full sternotomy20.
A recent report21 suggested patients who experienced simultaneous bilateral anterior approach total hip arthroplasty enjoyed low rates of perioperative complications and excellent clinical outcomes. The retrospective review for 75 patients found mean blood loss was 565 mls, with 13 patients not being transfused. In the first 25 patients, the average volume transfused was 2.6 units, while in the remaining 50 patients the average volume transfused was 1.6 units.
Treating iron deficiency
Medgenics began patient enrolment in Phase II clinical trial in the US of MDGN-201 (TARG-TEPO), a gene therapy designed to treat anaemia in end stage renal disease) in patients who are undergoing peritoneal dialysis.
The first cohort of patients treated by Xenetic Biosciences in a Phase II trial for ErepoXen (a treatment for anaemia in patients with chronic kidney disease) saw their haemoglobin levels rise but not into the therapeutic range. Now in a second cohort 91 per cent of the enrolled patients increased haemoglobin levels, while three-quarters of them had their haemoglobin levels rise into the therapeutic range. Haemoglobin levels stayed within the therapeutic range for the rest of the 17-week study. In both cohorts, ErepoXen appeared well tolerated without any significant treatment related adverse events. A third cohort will be given higher doses in an attempt to identify the optimal therapeutic dose. Principal investigator is Professor Simon Roger at Gosford Hospital.
A Cornell-led study22 found that iron bio fortified pearl millet23 resolved iron deficiency in a group of school-aged children in India within four to six months, compared with a control group fed unfortified pearl millet for the same time period.
Other.
A randomized study24 of 168 patients confirmed that CSL Behring’s Kcentra (4-factor prothrombin complex concentrate) reversed the anticoagulation effects of vitamin K antagonists (VKA) at a faster rate than plasma in patients requiring emergency invasive procedures. The results are consistent with previous studies, including another randomized trial of only 20 patients25.
Verax Biomedical renewed its exclusive worldwide commercialization agreement with Fresenius Kabi USA to market Verax's PanGenera Detection (PGD) test. This rapid in vitro test is used to detect bacterial contaminants in donated platelets26. It is the only rapid test approved by the FDA for all commonly available US platelet types.
Scientists funded by Australia’s National Heart Foundation have been working towards a revolutionary treatment for blood clots that could be administered by paramedics without the need for specialised equipment as is currently the case27. Professor Christoph Hagemeyer, Head of the Vascular Biotechnology Laboratory at Baker IDI Heart and Diabetes Institute, said: “We’ve created a nanocapsule that contains a clot-busting drug. The drug-loaded nanocapsule is coated with an antibody that specifically targets activated platelets, the cells that form blood clots……..Once located at the site of the blood clot, thrombin (a molecule at the centre of the clotting process) breaks open the outer layer of the nanocapsule, releasing the clot-busting drug. We are effectively hijacking the blood clotting system to initiate the removal of the blockage in the blood vessel”. Joint leader of the project, Professor Frank Caruso, an ARC Australian Laureate Fellow in the Department of Chemical and Biomolecular Engineering at the University of Melbourne said the targeted drug and novel delivery can potentially offer a safer alternative with fewer side effects. He said: “Up to 55,000 Australians experience a heart attack or suffer a stroke every year…….About half of the people who need a clot-busting drug can’t use the current treatments because the risk of serious bleeding is too high”.
St. Teresa Medical of St Paul, Minnesota, has enrolled the first patient in its UK clinical trial of its Surgiclot wound dressing to reduce blood loss. The 40 patient trial will support the company’s application for CE Mark certification. The company says Surgiclot dissolves in seconds to minutes, leaving behind a clot which can achieve haemostasis in under three minutes.
BioLife Solutions of Washington State announced that manufacturing process validation has begun to support a new product, BloodStor 27 NaCl, directed towards cryopreservation, including freezing of platelets for subsequent clinical use. Mike Rice, the company’s CEO, said: "We have been monitoring clinical use of frozen platelets for hemodynamically unstable patients and have been in discussions with leading international clinical centers about the need for a stable supply of GMP manufactured, clinical grade freeze media for freezing therapeutic platelets. Additionally, there is clearly strong interest to improve battlefield trauma care for wounded warriors28. We believe that we can add incremental revenue by expanding our product portfolio with this new GMP grade bio preservation media." BioLife expects inventory of BloodStor 27 NaCl to be available to fill orders early in the fourth quarter of 201529.
