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:
1)
to decide if I am capable of giving an informed consent
2) to discuss my reasons
why I want to be a donor
3) 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
BENFITS
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