Download outpatient consent to hemapheresis procedures

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OUTPATIENT CONSENT TO
HEMAPHERESIS PROCEDURES
Doc. #6495
Rev. 05/10/2013
Page 1 of 2
One Box Must be checked:
Therapeutic Apheresis (Plasmapheresis, Thrombocytapheresis, Erythrocytapheresis, or Leukocytapheresis)
Photopheresis
LDL Apheresis
I.
My physician has informed me that he/she has requested the American Red Cross Blood Services, to perform one or
more automated hemapheresis procedures to help manage my disease. My physician has explained the possible
benefits and potential risks of this procedure, as well as possible alternative thereapies, and has obtained my
consent. However, I understand that there are no guarantees concerning the outcome. The specific procedure that
will be performed is checked off above, and described below.
II. For all procedures, the procedure will begin with the removal of blood from a vein in my arm and/or from a central
access device, and my blood will be processed in an instrument where it is separated into plasma and cells. The
frequency of treatment is established in consultation with my physician.
a. For a Therapeutic Apheresis procedure, a blood component will be removed and the rest of my blood will be
returned to me. An appropriate volume of salt solution, albumin, plasma, and/or red blood cells will be given
to me as a replacement fluid. If the replacement fluid includes red blood cells and/or plasma, complications
such as an allergic reaction or transmission of an infectious disease, such as hepatitis, may occur. I
understand that the blood will be supplied to me in accordance with protocols in place at Crouse Hospital. I
understand that in certain rare instances the blood supplied might be defective including the transmission
of hepatitis or other infectious disease. I likewise understand that there is no protocol method to determine
such a defect.
b. For a Photopheresis procedure, a medication, 8-Methoxypsoralen 8-MOP®, will be given to me by mouth or
added to my collected cells and plasma. My white cells will be photoactivated by exposing the cells to
ultraviolet light (UVA). The treated blood, and my red blood cells and plasma are then returned to me through
the same access used to withdraw the blood for processing.
c. For LDL Apheresis, my separated plasma will be processed with LDL absorption columns for the purpose of
removing LDL-cholesterol and then returned to me with the rest of my blood.
III. I understand there are certain risks associated with this procedure. As with whole blood donors, reactions such as
nausea, vomiting, dizziness, fainting, and rarely, seizures may occur. Bruising, slight pain, and very rarely
inflammation or infection may occur at the needle puncture site. Because blood cools when it is in the apheresis
machine, I may feel cold during the procedure. Two infrequent complications are air embolism (which may occur if air
gets into the equipment) and damage to red blood cells (which may occur if there are defects in the plastic disposable
equipment).
IV. I understand that during the procedure, citrate is used to prevent my blood from clotting. Citrate may cause a chilly
sensation, tingling around my mouth, muscle tightness or pain, and a feeling of anxiety. These reactions can be
controlled by slowing down the rate at which my blood is returned, or by giving me a source of calcium, such as milk
or antacid tablets.
V.
For Photophersis and LDL Apheresis procedures, I understand that heparin may be used to prevent my blood from
clotting. Heparin may cause minor bleeding at any site within the body and abnormal laboratory values for clotting
activity in my blood. The amount of heparin used during this procedure rarely causes difficulty, but I understand
that Red Cross cautions against physical activities that may result in possible injury 4-24 hours following each
procedure. In addition, as a result of the photopheresis procedure, I may also have a temperature elevation for several
hours after treatment. Because of taking 8-MOP®, I should protect myself from ultraviolet light exposure by covering
my extremities as well as wearing UVA protective wraparound eyewear to protect eyes for at least 3 days from the last
dose or treatment.
OUTPATIENT CONSENT TO
HEMAPHERESIS PROCEDURES
Doc. #6495
Rev. 05/10/2013
Page 2 of 2
VI. Since low blood pressure is the most common effect of LDL Apheresis I understand that if I am taking high blood
pressure medication, that I must inform my doctor and the apheresis staff and I may be advised to stop taking
certain kinds of high blood pressure medications for a day before the procedure.
VII. I understand that if a mechanical failure occurs, making it impossible to return the red blood cells from the
machine, the amount of red blood cells I would lose would be similar to a regular whole blood donation.
VIII. During the course of the procedure, unforeseen conditions may occur. I understand my physician, his/her
assistants or designees may perform such therapies or procedures as may become necessary in his/her
professional judgment as a result of, or subsequent to, this procedure.
IX. I understand that blood samples may be drawn at the beginning and end of each procedure to monitor my
progress.
.
The procedure has been explained to me by (provider name)
I acknowledge that I have had the opportunity to ask questions regarding this proposed hemapheresis procedure and that
all my questions have been answered to my satisfaction. I understand that I may withdraw from this form of therapy at
any time and I would then be referred to my physician for subsequent medical care.
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Date/Time
Authorized Signature
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Date/Time
Witness of Authorized Signature/Title
This consent is valid for one year for outpatient procedures only.
(If blood components are transfused, a Consent to Transfusion of Blood or Blood Components is required)