PolyHeme Trauma Trial

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PolyHemeTrauma Trial

• Methodist Hospital
• Wishard Hospital
• www.Clarian.org
• www.Wishard.edu

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Background

• Trauma a leading cause of death in Americans
  under age 45
• Strikes in prime of life
• 60 of deaths occur in rural areas
• 47 million Americans live more than 1 hour from
  trauma center
• Ambulances dont routinely carry blood
• Many patients die before access to blood

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What is PolyHeme?

• A blood substitute
• that carries oxygen
• 1 unit PolyHeme 1 unit blood
• Made from human blood
• Compatible with all blood types
• Can be stored for more than 1 year

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Prior Studies with PolyHeme

• Carries oxygen like blood
• Can sustain life in bleeding patients without
  blood
• Therefore may improve survival when blood is
  needed but not available

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Past Experience With PolyHemeIn-hospital
Mortality Without Blood
Transfusion 2002
JACS 2002
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Study Purpose

• To assess the survival of patients in shock due
  to bleeding from their injuries
• treated with
• PolyHeme or Control (standard of care)

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What is the Current Standard of Care?
In the Ambulance The patient receives IV
salt water (blood is not
available)
In the Hospital The patient receives IV
salt water and
donated blood
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Study Design Before the Hospital

• Severely injured trauma patients were assigned to
  one of two groups by chance

Standard of Care(Control) Receive IV Salt Water
Test(PolyHeme) Receive IV PolyHeme
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Study Design At the Hospital

• Control
• Salt water to replace lost blood
• Donated blood to boost oxygen levels

• PolyHeme
• Salt water to replace lost blood
• PolyHeme to boost oxygen levels
• Up to 6 units of PolyHeme during first 12 hours
• Donated blood after PolyHeme if needed

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Who Was Included In The Study?

• Patients at risk of dying
• Severe injuries
• Lost a large amount of blood, in shock
• At least 18 years old

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Who Was NOT Included?

• Pregnant
• Serious head injury
• Requiring CPR
• Known objection to blood

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Study Results
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Who Participated

• 32 Level I trauma centers in 19 states
• 300 ambulances
• 3500 EMTs
• 150 physician investigators
• 1500 laboratory personnel
• 1000s allied hospital staff

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Study Sites
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Study Patient Characteristics
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Methodist Wishard Hospitals
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Results Study Overall
714 patients 82 patients died
349 Received PolyHeme 46 Deaths (13)
365 Received Control 36 Deaths (10)
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Results Efficacy

• The difference in deaths between the groups fell
  outside the boundary agreed upon with FDA
• However, the difference in deaths between the
  groups was not statistically significant
• The outcomes of patients in both groups were
  similar

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124 Patients had Protocol Violations

• Shouldnt have been enrolled
• No blood pressure in field
• Head injury or abnormal brain function
• Undergoing CPR
• Did not receive the assigned treatment

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Results Protocol Followed Correctly
590 patients 60 patients died
279 ReceivedPolyHeme 31 Deaths (11)
311 ReceivedControl 29 Deaths (9)
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Our Results
70 patients 6 patients died
Received PolyHeme 4 Deaths
Received Control 2 Deaths
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Adverse Events (AEs)

• AE has an FDA definition
• Basic definition any physical or laboratory
  abnormality that happens to a patient in a trial
• An AE is not necessarily caused by the product
• 324 of 349 (93) PolyHeme patients
• 322 of 365 (88) Control patients

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Most Common AEs Reported inBoth Groups
PolyHeme
Control Low calcium/potassium 32
34 Anemia 35
32 Fever 29
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Serious Adverse Events (SAEs)

• SAE has an FDA definition
• Basic definition life-threatening and other
  medically important AEs
• An SAE is not necessarily caused by the product
• 141 of 349 (40) PolyHeme patients
• 126 of 365 (35) Control patients

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Most Common SAEs Reported inBoth Groups
PolyHeme
Control Pneumonia 8 6 Multiple
organ failure 7 6 Respiratory
failure 6
5
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Heart Attacks

• Diagnosing heart attacks in trauma patients is
  complicated, particularly in those with chest
  injuries
• Of the 714 patients, heart attacks were reported
  in 11 PolyHeme and 3 Control patients
• None of the heart attacks were considered by the
  investigator to be possibly or probably
  related to the study treatment
• Only one in each group required intervention
  (cardiac catheterization)

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Combined Cardiovascular Events
PolyHeme
Control Heart failure events 5 5 Serious
rhythm disturbances 4 2 Stroke
syndromes 1 1
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Study Implications Benefit-to-Risk

• PolyHeme intended for use in bleeding patients
  without early access to blood
• Not in place of blood
• Benefit-to-risk considerations
• Patients at risk of dying
• High mortality without blood
• No available alternative carries
  oxygen

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Conclusion

• PolyHeme can provide a survival benefit to
  bleeding patients without access to blood

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For questions contact Rick Lowry,
RN rlowry_at_clarian.org Or Gretchen
Huffman,RN Gretchen.Huffman.Wishard.edu