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MANDATE
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Maternal and Neonatal
www.mnhtech.org
Directed Assessment
of Technology
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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
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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.
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Hemopure and Polyheme use bovine and human Hb respectively, and do not require refrigera-
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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.
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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
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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.
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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
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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
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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