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Plasma Exchange for Specific Neurological Patients

FAST ROAD TO RESULTS FIRST-LINE THERAPY HOW IT WORKS SAFETY RESOURCES REFERENCES
®

“Plasma exchange is known to be safe and well tolerated, with the majority of reactions being mild, easily treated and of limited duration. TPE safely treats various patient types including those with comorbidities.”

(Winters 2012)




VASCULAR ACCESS


Think Peripheral Access First

Many patients receive peripheral venous access treatment. AEs are lower with centrifugal apheresis versus membrane apheresis in cases where peripheral access is an option.

Of 1,207 plasma exchange procedures, 79.3% were conducted via peripheral access.

(Noseworthy 1989)

ADVERSE EVENTS (AEs)




The World Apheresis Association registry data update of over 15,000 centrifugal apheresis procedures reported reported 93.9 percent of patients did not experience any adverse events (AE). Of the 6.1 percent of patients that did experience AEs, the type of severity of reactions are detailed below: (Mortzell Henriksson, 2016)

1.6% Mild (tolerated without medication): access issues, device malfunctions, hypotension, tingling
3.8% Moderate (needed medication due to AE): tingling, urticaria, hypotension, nausea
0.7% Severe (interrupted due to AE): syncope/hypotension, urticaria, chills/fever, arrhythmia/asystole, nausea/vomiting

(Mortzell Henriksson 2016)








GENERAL SAFETY


    Contraindications
  • No known contraindications for the system's use, except for those associated with all automated apheresis systems
  • The infusion of certain solutions and replacement fluids may be contraindicated in some patients
  • Possible patient reactions
  • Anxiety, headache, lightheadedness, digital and/or facial paresthesia, fever, chills, hematoma, hyperventilation, nausea and vomiting, syncope (fainting), urticaria, hypotension and allergic reactions
  • Reactions to transfused blood products can include:

    (AABB, 2006)

  • Fever, circulatory overload, shock, allergic reactions, alloimmunization, graft-versus-host disease and transmission of infection
  • Restricted to prescription use only
  • Operators must be familiar with the system's operating instructions
  • Procedures must be performed by qualified medical personnel
  • A supervisory practitioner may supervise from a physician office or other nonhospital space that is not officially part of the hospital campus as long as he or she remains immediately available

    (American Society for Apheresis, 2007)

For all other warnings and cautions associated with Spectra Optia, please refer to the safety information and the operator’s manual.








Safety Information

Contraindications

  • No known contraindications for the system's use, except for those associated with all automated apheresis systems
  • The infusion of certain solutions and replacement fluids may be contraindicated in some patients

Possible patient reactions

  • Anxiety, headache, light-headedness, digital and/or facial paresthesia, fever, chills, hematoma, hyperventilation, nausea and vomiting, syncope (fainting), urticaria, hypotension and allergic reactions

Reactions to transfused blood products can include1

  • Fever, circulatory overload, shock, allergic reactions, alloimmunization, graft-versus-host disease and transmission of infection

Restricted to prescription use only

  • Operators must be familiar with the system's operating instructions
  • Procedures must be performed by qualified medical personnel
  • A supervisory practitioner may supervise from a physician office or other nonhospital space that is not officially part of the hospital campus as long as he or she remains immediately available2

1AABB (ed.), et al., Circular of Information for the Use of Human Blood and Blood Components. 2006, tenth edition, Council of Europe Publishing, Seattle, WA.

2American Society for Apheresis. Guidelines for therapeutic apheresis clinical privileges. J Clin Apher. 2007;22(3):181-182.




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