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MANDATE ----------------------------------------------------------------------------------------------------------------------------------------------------------------------- Maternal and Neonatal www.mnhtech.org Directed Assessment of Technology ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Blood Substitutes TREATMENT FOR SEVERE ANEMIA OR BLOOD LOSS PREVENTION DIAGNOSTIC TREATMENT Condition Bleeding or severely anemic patients may require blood substitutes to replace lost blood volume, lost oxygen carrying capacity, or both. Volume expanders are typically indicated when blood loss exceeds 15% of volume,(typically 5 liters), blood pressure falls, heart rate rises, and breathing speeds up. Increased oxygen carrying capacity may be indicated when the hematocrit falls below 20% or the HgB falls below 7 g/dl. Mechanism of Action Plasma volume expanders can be crystalloid or colloid. Crystalloids like saline or Lactated Representative Product Ringer’s are typically less expensive, but require 3 to 4 times more volume for replacement as ------------------------------------------------ they move rapidly to extracellular spaces. Colloid substances like Voluven or Hespan are sus- WORLDWIDE ANNUAL DEATHS ASSOCIATED WITH HEMORRHAGE AND SEVERE ANEMIA pensions of larger, insoluble molecules, designed to stay in the vessels. Neither is considered superior in the treatment of obstetric hypovolemia. Patients who need greater oxygen carrying capacity can be given packed red blood cells, whole blood, or an oxygen-carrying blood PERCENT (%) NUMBER Maternal 4-35% 14,320-125,300 Neonatal 1-10% substitute. The substitutes use either hemoglobin (Hb) or perflurocarbon (PF) to carry oxygen. ------------------------------------------------ Hemopure and Polyheme use bovine and human Hb respectively, and do not require refrigera- ------------------------------------------------ tion. Oxycyte and Perftoran use small particles of PF but must be stored at low temperatures. 37,000- 370,000 These substitutes are typically not indicated if blood products are available. ------------------------------------------------ Current use in high-resource settings *Estimates under development Stillbirth * * For volume expansion, crystalloid and colloid solutions are readily available and frequently used with a large caliber intravenous access. When indicated, oxygen carrying capacity is typically restored either with packed red blood cells or whole blood. Wealthy countries represent approximately 18% of the population, but use approximately 61% of the global blood supply, partly because blood banking is well developed and trusted. Oxygen-carrying blood substitutes are not in high demand, partly because safe blood products are often readily available. Application in low-resource settings Crystalloid plasma volume expanders are readily available and used in tertiary care centers and some clinics as a staple product. Oxygen carrying capacity is typically restored through banked whole blood or packed red cells, but in regions where the blood banking system is under developed, donors are usually family and friends who come with the patient. While Hb and PF based oxygen carrying substitutes hold promise, given their long shelf lives and lowered risk of disease, they are only indicated where transfusing whole blood or packed cells is not feasible, and have yet to gain widespread acceptability (or regulatory approval). REPRESENTATIVE DEVICES MAKE MODEL PRICE* TECH STATUS NOTES Human Blood Whole Blood $225 Whole Blood Marketed Prices and safety vary Hospira Voluven $70 Colloid Marketed Branded, premium product Generic Lactated Ringers $1 Crystalloid Marketed Generic, commodity product Oxygen Biotherapeutics Oxycyte N/A Perflourocarbon Trials Not indicated for hemorrhage Perftoran Perftoran N/A Perflourocarbon Marketed Limited sales beyond Russia OPK Biotech Hemopure N/A Bovine Hb Discontinued Used in South Africa since 2001 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------*Per 500mL, Prices are approximated. Actual pricing can, and will vary by marketplace and market conditions. CHARACTERISTICS OF REPRESENTATIVE PRODUCT (LACTATED RINGER’S) TECHNOLOGY CHARACTERISTICS OPERATIONAL PARAMETERS POTENTIAL OPPORTUNITIES FOR IMPROVEMENT --------------------------------------------------------------------------------------------------------------------------------------------------------- Intended end user Physician, NICU nurse Use of lactated ringer’s still requires considerable skill, not only to set up SKILLS REQUIRED Training required Hours Time required per use Minutes the IV, but also to prevent overdosing the patient. Too much fluid can result in pulmonary edema. --------------------------------------------------------------------------------------------------------------------------------------------------------- ENVIRONMENT / INFRASTRUCTURE Power required None Waste collection Sharps Complementary 14-16 gauge needle, tub- technologies required ing, IV stand, sterilizing wipes, tape Temperature and storage Store at room temperature Maintenance None --------------------------------------------------------------------------------------------------------------------------------------------------------- Device Cost (Approx) <$1 Cost of the crystalloid is unlikely to be an issue (relative to other costs of care). COST Cost/course (Approx) <$1 --------------------------------------------------------------------------------------------------------------------------------------------------------- Portability 500g Regulatory Widely approved OTHER Clinically equivalent to Efficacy more expensive colloid solutions Additional devices required for impact: Method to diagnose blood loss, method to stop bleeding, measures to estimate shock such as blood pressure, pulse --------------------------------------------------------------------------------------------------------------------------------------------------------Sources: Martel, Marie-Jocelyn. Hemorrhagic Shock. SOGC Clinical Practice Guidelines. Society of Obstetricians and Gynecologists of Canada. No. 115 June 2002. Koistinen, Jukka. Building sustainable blood services in developing countries. Transfusion Alternatives in Transfusion Medicine, Volume 10, Number 2, June 2008 , pp. 53-60. Company web sites Reviewed on 12.6.11