Red Blood Cells
Red Blood Cells : Platelets
Mononuclear Cells : Fresh
Hemostasis : Resuscitation
FDA approval for the extension of frozen storage of red blood cells:
One of the things we hope to accomplish is to persuade the FDA to
allow for longer frozen storage of red blood cells. The FDA
has approved the frozen storage of red blood cells for up to 10 years.
However, our laboratory has provided data to the Navy Blood Program
Office and Armed Services Blood Program Office which shows that red
blood cells can be frozen for up to 37 years with no significant damage.
FDA is currently reviewing our submission for extension of the frozen
red blood cell storage and a decision is expected soon.
significance: The Department of Defense currently has more
than 60,000 units of frozen red blood cells stockpiled. Several
thousand of these frozen red blood cell units are nearing the 10-year
outdate. FDA-approval of an extension in the acceptable period
for frozen storage of red blood cells will save the Department of
Defense the cost of replacing these high-quality frozen red blood
significance: Like DOD, some civilian facilities
have also stockpiled frozen red blood cells for use in emergency
shortages and approval of this extension will also save them the
costs of replacing these red cells.
FDA approval of a closed, automated system to glycerolize (freeze)
and deglycerolize (wash) red blood cells: Also as part of our
frozen red blood cell program, we have evaluated a new automated machine,
the Haemonetics Model 215, which the FDA considers a 'closed' system.
The term 'closed' means that there is no potential for bacterial contamination
to occur during the red blood cell freezing and washing procedures.
The current systems are considered 'open', and have the potential
for bacterial contamination occurring during either the freezing or
washing procedure, and the FDA has determined that these previously
frozen red blood cells can be stored for only 24 hours following thawing
and washing. The need for the limited 24-hour post-wash storage
period with the current systems is understandable. If the red
blood cells did become contaminated during the freezing or washing
procedures, the longer they are stored in the refrigerator following
washing, the better the chance the bacteria could repopulate and cause
a transfusion reaction. However, this limited post-wash
storage period requires that frozen red blood cells be thawed and
washed only when the need to use them within the 24 hour period is
certain. The new 'closed' system eliminates the potential for
bacterial contamination. Data provided to FDA by our laboratory
as part of a multi-center study have shown that red blood cells processed
using the Haemonetics 215 closed system can be stored for up to 15
days following washing with acceptable results. Based on these
data, the FDA has approved the Haemonetics 215 system with post-wash
storage of previously frozen red blood cells for 14 days following
washing. It is expected that this extension will result in an
increased use of frozen red blood cells in both the civilian and military
significance: The Department of Defense currently
stockpiles frozen red blood cells for use in emergency situations.
This new, automated system will not only allow for increased post-wash
storage but will also increase productivity. Because the new
system is automated, 1 technician can operate 8 to 10 machines at
significance: Approval of a closed, automated system
with an extended post-wash storage period will simplify the use
of frozen red blood cells allowing civilian centers to use frozen
red blood cells for inventory control. This is especially
important in light of the recent American Red Cross blood shortages.
NBRL is attempting to obtain FDA approval for frozen platelets.
Platelets, the cells in the blood which are used to stop bleeding,
can be stored at room temperature for no more than 5 days. Platelets
cannot be stored in the refrigerator at 4 C because they undergo shape
changes that reduce their survival following transfusion. The
disadvantage of the warmer room temperature storage is that it increases
the risks of bacterial contamination. Our laboratory began evaluating
methods to freeze platelets in 1972. From that time to the present,
we have developed a relatively simple procedure to freeze platelets
with a chemical called dimethyl sulfoxide (DMSO) which allows for
frozen storage of the platelets at -80 C for up to 2 years.
The data we have obtained using this platelet freezing method have
been submitted to FDA and we are currently awaiting their response.
We are currently developing a method where we remove most of the DMSO
before the platelets are frozen, thereby eliminating the washing step
after freezing. This would significantly simplify the procedure
for use by the civilian and military communities.
significance: The limited 5-day liquid storage period
does not allow enough time for the platelets to be collected at
fixed facilities and transported to the field. The Department
of Defense currently has stockpiled more than 60,000 units of frozen
red blood cells. Once our platelet program is FDA approved,
frozen platelets can be stockpiled along with frozen red blood cells.
The military would then be ensured of a supply of platelets adequate
for their needs.
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significance: Platelet availability in the civilian
community is also affected by their limited storage period.
Single-donor platelets are expensive to collect and a method is
needed to preserve them when quantities are high.
mononuclear cells isolated from peripheral blood can be frozen with
10% DMSO and stored at -80 C for 1?years. The procedure to freeze
pluripotential mononuclear cells has been modified by the removal
of supernatant DMSO prior to freezing. This modification eliminates
the need for post-thaw washing prior to transfusion.
and civilian significance: These HLA and ABO compatible
previously frozen mononuclear cells can be used to treat individuals
exposed to radiation injury.
continuing to evaluate prolonged frozen storage of the plasma component
of blood. Plasma is the component of the blood that contains
clotting proteins and it is used to treat individuals who are actively
bleeding. Until our data was provided to FDA, plasma could
only be stored at -20 C for up to 1 year. Data collected at
our laboratory demonstrated that the plasma could be stored at the
colder temperature of -80 C for as long as 7 years. Studies
are now being done to determine if the plasma can be stored at -80
C for up to 12 years.
and civilian significance: Extension of the acceptable
frozen storage of plasma will save both the military and civilian
communities the cost of replacing stockpiled frozen plasma.
the past 5 years, our laboratory has expanded its focus from the preservation
of blood to the evaluation of ways to reduce blood loss and stop bleeding
in wounded individuals. Studies are being done in animals, normal
volunteers and patients.
of Red Blood Cells in the Reduction of Blood Loss: The
hemostatic function of red blood cells to prevent non-surgical blood
loss is a current area of active investigation. Studies are being
done to document that red blood cells are very important in hemostasis
and transfusion of red blood cells to increase the hematocrit to
35 V% should be done in patients with non-surgical blood loss prior
to the transfusion of platelets and fresh frozen plasma.
in vitro studies indicate that red blood cells may be responsible
to activate platelets to improve their function. Flow cytometric
studies of red blood cell and platelet surface markers are being
performed to determine the mechanism of the red blood cells action
on the platelet.
of Poly-N-Acetyl Glucosamine (p-GlcNAc) in the Reduction of Blood
Loss in Patients Subjected to Cardiac Procedures and in Rodents
Subjected to Hemorrhagic Shock: A new polymer, poly-N-acetyl
glucosamine (p-GlcNAc) has been identified and found to be effective
in achieving hemostasis in surgical procedures and trauma. The p-GlcNAc
material is a unique polymer structure isolated and purified from
large scale cultures of a marine microalga. The p-GlcNAc polymer
structure has been determined via infra-red (FTIR), NRM and CD spectral
data and is characterized as an ordered and regular (pseudo-crystalline)
structure. This unique structure has been linked to the hemostasis
performance of the product. Other polymers containing N-acetyl glucosamine
such as chitin, chitosan, and hyaluronic acid do not have the same
structure and do not exhibit the hemostatic activity, as demonstrated
by in vitro and in vivo assays.
A bandage composed of the substance poly-N-acetyl glucosamine (p-GlcNAc
or NAG) has been shown to reduce bleeding and blood loss in animals.
The NAG bandage is being evaluated as a safe, simple and effective
method for minimally trained military personnel to reduce bleeding
time and blood loss in injured casualties.
NAG bandage may also be used to control blood loss following injuries
or surgical procedures in the civilian community. It is simple enough
so that the first medical personnel at the scene could control the
bleeding until the patient could be transported to the hospital.
In addition to saving lives lost due to uncontrollable bleeding,
the NAG bandage may also reduce blood transfusion requirements,
which may be an important issue in these times of severe blood shortages.
on the results obtained with poly-N-acetyl glucosamine was held
at Brigham and Women's Hospital on February 25, 2003. The symposium
was organized by C. Robert Valeri, M.D. of the Naval Blood Research
Laboratory and hosted by Herbert Hechtman, M.D. of Brigham and Women's
Hospital and Harvard Medical School. The
abstracts presented at this meeting may be reviewed here.
together the animal and clinical data indicate that poly-N-acetyl
glucosamine, an FDA approved agent manufactured by Marine Polymer
Technologies Inc is an effective hemostatic agent whether applied
directly to gastric varices; topically against bleeding surfaces
of spleen or liver; against major wounds of the abdominal aorta;
or on cardiac cathetherization sites in the groin.
was achieved, even in the presence of full heparinization and in
acquired and congenital hemostatic defects. The mechanism of action
is due to local vasoconstriction and by the activation of the clotting
cascade through platelets and red cell activation.
preclinical and clinical data presented at this symposium support
a role for poly-N-Acetyl glucosamine in medical and surgical conditions,
particularly in trauma.
of Zeolite (QuikClotTM) To Reduce Blood Loss:
Studies are currently being done to assess the safety and efficacy
of zeolite as a hemostatic agent
vitro studies done to date have shown that addition
of zeolite to platelet rich plasma allowed the platelet-rich plasma
to quickly form a clot. Additional studies have shown that addition
of zeolite to platelet-rich plasma results in activation of the
platelets along with release of platelet-derived growth factors.
Platelets treated with zeolite produced about four times the platelet-derived
growth factors than untreated platelet-rich plasma. Additional studies
are being performed to determine how the zeolite interacts with
red blood cells, platelets and plasma proteins to form the clot.
were performed in rodents subjected to blood loss which demonstrated
that the QuikClotTM method reduced
blood loss and mortality. The zeolite "QuikClotTM" was
shown to be effective in reducing blood loss and improving survival.
Studies are being performed to determine if treatment with zeolite
produces adverse effects.
may review a PowerPoint presentation
of the study that was done to evaluate the safety and therapeutic
effectiveness of zeolite (QuikClot™) to restore hemostasis
in the rodent and to assess the mechanism of action of zeolite on
blood in vitro. (This slide show was presented at the annual ATACCC
(Advanced Technical Applications for Combat Casualty Care) meeting
held in St. Pete, FL in August 2003.)
resuscitation solutions: The NBRL is currently involved in
studies to assess new solutions to resuscitate individuals. Dr. Richard
Veech of the National Institutes of Health developed a novel resuscitation
solution to replace the commonly used lactated Ringer's intravenous
solutions. Studies done by Dr. Veech, as well as other investigators,
have shown that the lactate in Ringer's lactate solution may produce
deleterious effects. This new solution, referred to as Ringer's ketone
solution, uses ketones in place of the lactate.
has worked with commercial companies to prepare large volumes of the
Ringer's ketone solutions for evaluation by our laboratory and other
investigators. The solution is being evaluated by our laboratory for
chemical composition and stability as well as efficacy in a rodent
shock model. Other Office of Naval Research-funded investigators are
also evaluating the solutions we prepared in their animal models:
Drs. Peter Rhee and Hasan Alam of the Uniformed Services University
of Health Sciences (USUHS), Dr. George Kramer of the University of
Texas and Dr. Susan Stern of the University of Michigan.
PowerPoint presentation evaluates
the storage stability of large volume parenteral ringer's ketone solutions
prepared by filter sterilization. (This slide show was presented at
the annual ATACCC (Advanced Technical Applications for Combat Casualty
Care) meeting held in St. Pete, FL in August 2003.)
oxygen carriers: Routinely
crystalloid and colloid solutions are used to resuscitate hypovolemic,
hypotensive individuals. These solutions have limited effectiveness
in maintaining blood pressure. Colloid solutions had been considered
to be superior to crystalloid solutions because they remain in the
circulation longer. Recent studies, however, have suggested that the
use of albumin may increase morbidity and mortality.
based oxygen carrier solutions were developed as colloid solutions
with the added benefit of having the ability to carry and deliver
oxygen. Studies have shown that unmodified HBOC is not an optimum
resuscitation solution because it has an unacceptably high oxygen
affinity and it induces vascular constriction of vascular beds. HBOC
solutions were modified using various techniques to reduce these adverse
are being done by our laboratory to assess the effect of hemoglobin-based
oxygen carriers (HBOC) in rats subjected to a 50% exchange transfusion.
The hemoglobin based oxygen carriers are compared to fresh blood and
oncotic substances like hetastarch or pentastarch. This study will
examine the effects of an exchange of 50% of the blood volume in rats
with whole blood, a clinically available colloid (albumin, hetastarch
or pentastarch) and two modified SFH solutions.
the PowerPoint presentation that examines
the effects of a 50% exchange transfusion in rats with hemoglobin
based oxygen carrier solutions. (This slide show was presented at
the annual ATACCC (Advanced Technical Applications for Combat Casualty
Care) meeting held in St. Pete, FL in August 2003.)