Patient Consent

Consent for Plasma Exchange Apheresis Procedure

 

Description of Procedure

 

Your physician has ordered Plasma Exchange for you as part of the treatment of your medical condition.  Apheresis is a form of treatment in which your blood is made to flow through a needle in your arm, (or a special catheter placed in a large vein), into a machine which separates the blood into its liquid (plasma) and cellular (red and white blood cells, platelets) components. The machine diverts the plasma into a collection bag and the rest of the blood is returned to you though a needle in your other arm (or through the special catheter). The purpose of plasma exchange is to remove antibodies, or other substances from your blood which might be causing damage to your own tissues.

 

During the procedure, an anticoagulant will be added to your blood as it flows into the machine to prevent clotting.  Although some of the anticoagulant is returned to you with your blood, your body will rapidly process and eliminate it. Your blood will only come in contact with sterile disposable (used only once) equipment designed for these treatments.

You will receive back 5% Human Albumin to replace the amount of plasma collected.

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Potential Risks

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Plasma Exchange involves the following possible risks and /or discomforts:

 

1. Hematoma (bruise) or infection at the site of the needle insertion.  Discomfort may occur at the site of the needle, which will be in place for 2-3 hours.

 

2. The anticoagulant may cause tingling sensations around the mouth, hands, and body.  Muscle cramps, nausea, vomiting may occur, but this does not happen often.  There is a very small risk that the anticoagulation will lead to bleeding. 

 

3. Rarely, blood pressure may fall and lightheadedness may occur.  Shock, irregular heartbeats and death have been reported, but are extremely rare and are usually due to illness rather than the plasma exchange procedure.

 

4. Air embolism (large amount of air entering the circulation) is an extremely rate complication of apheresis that may cause death.

 

5. Allergic reactions, rarely fatal, to albumin have occurred.  Less severe reactions such as fever, hives and wheezing can occur and may require treatment.

 

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Expected Benefits and Duration of Therapy

Based on your medical condition, it is believed by your physician that a component of your blood is contributing to your illness or lack of well-being, and that removing it through a course of apheresis therapy will be of benefit.  Although no specific guarantees of success have been, or can be, offered, it is anticipated that this therapy will contribute to your recovery, or enhanced well-being. The actual course of therapy may involve repeated treatments over a period of days, weeks or months.  The actual number and the duration of treatments must be determined based on your specific diagnosis, height, weight and blood volume and your response to treatment.