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Advisory Committee on Organ Transplantation

U.S. Department of Health and Human Services

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:

  1. the living donor evaluation,
  2. the living donor surgery, itself,
  3. the long-term outcomes after the living donor surgery, and
  4. 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:

  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 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 External Web Site Policy 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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