U.S. Department of Health and Human Services
Advisory Committee on Organ Transplantation
Recommendations to the Secretary
LIVING LIVER DONOR INITIAL CONSENT FOR EVALUATION
I am thinking about donating a part of my liver to a patient
who has end stage liver disease. This patient's doctors have
decided that the best treatment for him or her is to receive
a liver transplant. He or she has been placed on a waiting
list for a cadaveric liver transplant. I am asking to be evaluated
as a potential liver donor.
In order for me to decide whether or not I wish to consent
to the living liver donor surgery, I should understand enough
about the risks and benefits of:
- the living donor evaluation,
- the living donor surgery, itself,
- the long-term outcomes after the living donor surgery,
and
- the recipient transplant surgery (recipient may not survive
even after getting a donor liver)
to make an informed decision. This process is known as informed
consent. This consent form provides detailed information about
the donor surgery (operation) that will be discussed with
me. I understand that I will need to sign this consent form
if I wish to proceed with medical evaluation for living liver
donation.
Liver transplantation using a living liver donor involves
two steps. The first step is a medical evaluation to decide
if it is possible for me to be a living liver donor. If it
is decided that I am healthy and a good match with the potential
recipient, and I consent to continue, I can then go on to
the second step. The second step is having surgery to remove
of a portion of my liver that will be transplanted into the
potential recipient. I understand that by going through the
medical work-up for donor surgery does not guarantee that
I will be able to donate my organ. I understand that I may
choose to stop the donation process at any time.
I also understand that I cannot receive any payment in exchange
for being a donor.
EVALUATION PROCESS
An initial work-up will be done to find out if I can donate.
This will involve a health care assessment along with some
laboratory blood and urine tests. I will also have an electrocardiogram
(EKG) and a chest x-ray. If the initial screen shows that
I can possibly be a donor, then I will enter the second phase
of the work-up. This is a more thorough phase that involves
a variety of tests and consultations. One benefit of the donor
evaluation is finding out about health problems that I did
not know I had but may need treatment for. My ability to get
health and life insurance in the future may be affected by
finding out about these health problems.
Depending upon my past medical history, more tests may be
needed. If these tests are normal and do not show a medical
problem that would stop me from being a good living donor,
I will then need to have more tests to measure the size, blood
flow and condition of my liver.
These tests may include, but are not limited to:
- ultrasound of the liver and blood vessels (a test using
sound waves to evaluate blood flow to the liver)
- CT scan to measure the volume of the liver (a test that
uses IV contrast (also called dye) to figure out the weight
of my liver)
- magnetic resonance scan of my liver (a test using magnetic
waves to study the blood vessels and bile ducts of my liver).
For some donors, more tests may be needed. These may include:
- a liver biopsy (a test in which a needle is used to remove
a small portion of my liver. The tissue is then looked at
under a microscope.)
- an angiogram (a test in which a needle is inserted into
a blood vessel in the leg and dye is used to take pictures
of the blood vessels of the liver).
Not every potential donor will need all of these tests. Each
test will be explained to me before it is done. Some tests
will have risks (the CT scan with dye, the liver biopsy, or
the angiogram). These risks will be discussed with me at the
time the test is planned and I will be asked to sign a separate
consent form.
A psychosocial work-up will be performed. There are three
main reasons for this work-up:
- to decide if I am capable of giving an informed consent
- to discuss my reasons why I want to be a donor
- to decide if my family and I will be able to hold up under
the emotional, financial and physical stresses of this type
of surgery.
Complications that can happen, including death to either
me or to the liver recipient, as a result of the evaluation
or the transplant procedures will also be discussed. There
are support systems in place at ____________________to help
me and/or my family go through this process. These systems
will be available to my family and me at any time during the
living liver transplant process.
During the work-up, I will be seen by an "advocate doctor."
This doctor is not involved in the care of the potential recipient
and is there to look after my health, safety and interests
throughout the liver donation process. This doctor will help
me decide if there are any medical or psychosocial problems
that would stop me from becoming a donor.
I understand and agree that, after the living liver donor
operation, my health insurance company may identify me as
having pre-existing liver disease and/or abdominal related
problems. As a result of having this living donor transplant
surgery, future liver disease or abdominal related problems
may not be covered by my insurance. If these problems are
not related to the surgery and are not covered by my health
insurance, I will be responsible for all costs.
I understand and agree that my insurance may be billed by
this hospital for denial of claims before the recipient's
insurance can be billed. I understand and agree that both
my future health, disability, and life insurance premiums
may be higher due to this donation. I understand and agree
that I also may not be able to get health, disability, and
life insurance in the future if I lose my current insurance
or if I am not now insured.
During work-up, the liver transplant team and my advocate
doctor will meet to decide whether I can donate or not. The
liver transplant team will let me know the result of the meeting.
If I am approved to donate, my surgeon will discuss the surgery
and the risks and I will be asked to sign a consent form for
the surgery. At all times, my health and safety will be the
primary focus.
At any time during the evaluation process, or prior to the
surgery, I am free to decide, for any reason, that I no longer
wish to become a donor.
SURGERY
Interrupted Surgery
The evaluation process of the potential donor and recipient
does not stop when the surgery begins. It continues throughout
the surgery. If at any point the surgical team believes that
I am at risk or that the segment of my liver is not right
for transplantation, the surgery will be stopped. This happens
in the United States at least 5% of the time.
Risks
The surgery that I will have is called a partial hepatectomy
(the surgical removal of a part of my liver). This surgery
is most commonly used to treat liver diseases. Partial hepatectomy
can be done safely. But with any major surgery, there are
risks involved, even the risk of death. Partial hepatectomy
in a well person carries less risk than when it is done to
treat someone who is sick with liver disease.
My gallbladder will be removed during this surgery. The gallbladder
is not needed for my normal function. Some people who have
their gallbladder removed have periods of diarrhea and cramping,
which may last for two-three months.
There are always risks with any surgery, but a surgery that
will remove between 25-60% of the liver carries more than
the average risk. Pain, bleeding, infection and/or injury
to other areas in the abdomen, as well as death, are potential
risks. Other risks include postoperative fevers, pneumonia,
and urinary tract infection.
Patients who have abdominal surgery are also at risk to form
blood clots in their legs. These blood clots can break free
and move through the heart to the lungs. In the lungs, the
blood clot may cause a serious problem called pulmonary embolism.
Pulmonary embolism is usually treated with a blood thinner.
In some cases, these clots can cause death. There are special
devices used to keep blood flowing in the legs during surgery
to try to prevent the blood clots from forming.
There are also risks that are specific only to liver surgery.
During the pre-surgery evaluation, the transplant team tries
to find out what my liver looks like so that they can decide
what piece can safely be taken out. For the living liver donation,
25-60% of the liver will be removed. Removal of a portion
of the liver may cause the remaining liver to not work as
well for a short period of time. The part of the liver left
behind will begin to grow back within a few weeks and get
better. But, a person who has a piece of his/her liver removed
can develop liver failure. In some cases, this liver failure
may require a liver transplant to treat. This is a very rare
event (about 2 transplants per 1000 living liver donor surgeries).
This has happened in this center_______times.
The most common liver problem (complication) after surgery
is a bile leak. The rate of this happening across the country
ranges from 5-15%. At this center, _____% of donors have had
bile leaks after surgery. Most bile leaks get better without
having to have another surgery. A leak may need for me to
have tubes placed that pass through the skin and into the
liver to drain bile from the liver into a bag worn outside
the body for a period of time. This often can be done without
having surgery.
Biliary strictures (narrowing of the large ducts that drain
the liver) can also occur after this surgery. Since this will
be a long-term complication and living liver donor transplants
are so new, there is not enough data to know how often this
will occur. Early data shows that strictures will be rare.
Some of them can be fixed without surgery.
Another rare event that may happen is injury to the spleen
during the surgery. If this occurs, the spleen will be removed.
The spleen helps to prevent bacterial infections, most commonly
pneumonia. Getting a vaccination can usually prevent these
infections. These infections can also be treated with antibiotics.
If the infections are not treated, they can cause death.
Across the country, the risk of having some type of problem,
minor or major, from this surgery is 15-30% (about 2 in 7
cases). At this center, _____% of donors have had problems
after surgery. Most problems are minor and get better on their
own. Rarely do they require another surgery or procedure.
Living liver donor transplants are still very new so there
may be risks that are not yet known.
So far in the United States, the mortality rate (death) has
been about 0.2% or 2 deaths in about 1000 donors. _________living
liver donors have died in this center.
General Anesthesia
This surgery will be done under general anesthesia. There
are a number of known possible risks with any surgery done
under general anesthesia. An anesthesiologist will explain
these to me and I will need to sign a separate consent for
anesthesia.
Blood Transfusions
I may need blood transfusions during this surgery, although
transfusions are usually not necessary during the surgery.
It may be possible to bank my own blood before the surgery.
I may need more blood than I have banked. During this surgery
and after care, I clearly consent to the use of stored blood
or blood products if it is needed. I have been fully informed
of the associated risks with the use of blood or blood products.
Although the blood is carefully checked for HIV, Hepatitis
and other diseases, there is still a very small risk that
I will be infected.
Post-Surgical Course/Discomforts
I further agree that after my surgery, drains will be placed
in my body to help me heal. I will go to a unit (hospital
floor) where I will be closely watched. There is a chance
that I could be placed on a machine to help me breath after
surgery. I will feel pain (for example: gas pains, sore throat,
soreness, backaches, etc.) after the surgery. I also understand
that I may become confused for a short time because of medications.
At some point I will be moved to a less acute floor.
I will remain in the hospital as long as needed, depending
on how fast I get better. Usually, donors are discharged 7
days after surgery. For the most part, donors are usually
pain-free three weeks after the surgery; some people continue
to have pain for a longer period but this unusual. The recovery
period at home is 4-6 weeks. Should I have surgical complications,
the recovery period may be longer. Most donors return to their
usual activities in ____ weeks. They usually return to their
most demanding activities in ___ months.
I understand and agree that a team of doctors at the __________________________
will follow me. My follow-up care will include doctor appointments
and having blood work and possible scans of the abdomen to
see how my liver is doing.
Insurance/Pre-existing Conditions
I understand and agree that, after the living liver donor
surgery, my health insurance company may identify me as having
a pre-existing liver disease and/or abdominal related problems.
Future liver disease or abdominal related problems may not
be covered by my insurance because I have been a living liver
donor. If these problems are not related to the surgery and
are not covered by my insurance company, I will be responsible
for all costs.
I understand and agree that my insurance may be billed by
this hospital for denial of claims before the recipient's
insurance can be billed. I understand and agree that both
future health and life insurance premiums may be higher due
to this donation. I understand and agree that I also may not
be able to get health, disability, and life insurance in the
future if I lose my current insurance or if I am not now insured.
Recipient Organ Failure
It is possible that the donor segment of my liver may not
work or may be rejected by the recipient's immune system.
This may require that he or she be placed on the Organ Procurement
and Transplantation Network (OPTN) list to wait for another
liver. During the waiting time, death may occur.
ALTERNATIVES
The alternative to living liver donation is cadaveric liver
donation, using a liver from a donor who is declared brain
dead. Should I decide not to donate a portion of my liver,
the potential recipient will continue to receive care by the
liver transplant team at ______________________________. His
or her name will remain on the Organ Procurement and Transplantation
Network (OPTN) liver transplant waitlist and he or she will
wait for a cadaveric donor organ or another living liver donor
to become available. The details of this process will be described
to me.
RECIPIENT BENEFITS
I understand that, by my donation, the recipient will receive
a benefit. For the most part, this benefit includes a decrease
in waiting time on the list, which might have an effect on
his/her recovery. Graft failure in the recipient occurs 5-10%
of the time and may lead to a repeat transplant or death.
The rate of this happening in this center is ______________.
DONOR BENEFITS
I understand that there is no medical benefit to me by having
this surgery. A possible medical benefit of the evaluation
is finding out about health problems that I did not know that
I had so that I may seek treatment.
CONFIDENTIALITY
Hospital personnel who are involved in the course of my care
may review my medical record. They are required to maintain
confidentiality as per law and the policy of this hospital.
If I do become a donor, data about my case, which will include
my identity, will be sent to the OPTN and may be sent to other
places involved in the transplant process as permitted by
law.
ADDITIONAL INFORMATION
I understand that I may obtain more information about living
liver donor transplants from the www.unos.org
web page. __________________ transplant program will contact
me from time to time after the surgery to learn about any
concerns I might have about my health, insurance, employment
and overall well being.
SIGNATURES
I have read this document. I understand the risk, benefits
and alternatives to living liver donation. I wish to proceed
with the evaluation to find out if I can be a donor.
______________________________________
Printed Name of Potential Donor
______________________________________ _____________
Signature Date
______________________________________
Printed name of Attending
______________________________________ _____________
Signature of Attending Date
______________________________________
Printed Name of Witness
______________________________________ _____________
Signature Date
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