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Can a heart valve replacement clinical trail refuse admission to trail because patient refuses blood?

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My 90 year old Mother (one of Jehovah's Witnesses) must have heart valve replacement surgery to continue living.  Standard valve replacement procedures are not a viable option for her.  Her cardiologist has tried to have her accepted into Medtronics CoreValve clinical trial in Houston, TX.  They refused her admission because she will not agree to use of blood transfusion "if there occurrs a problem during the procedure".  This procedure replaces heart valves without opening the chest cavity.  Can anyone offer information or suggestions that might help extend her life?  Time is a factor.
asked Oct 26, 2012 in Legal by vjac (120 points)
retagged Oct 26, 2012 by LarryEitel
Cleveland Clinic in Cleveland Ohio accepted my 80 year old father for heart valve replacement knowing he refused blood transfusion. He is doing well so far.
Thank you for sharing your information about your father's surgery.  May I ask if his procedure reqyured opening the chest cavity? And, how is he doing?
The procedure they used did not require opening the chest cavity. I think you can look up Cleveland Clinic online and find more information on the procedure for heart valve replacement that they used on him.

Here is a link:

http://my.clevelandclinic.org/heart/percutaneous/default.aspx

He is doing well and resumed his activities. It has been almost a year.

1 Answer

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Anyone doing a clinial trial has criteria for that trial, so possibly they will not except her for some reason because she falls outside the criteria.  Please contact me through this site because we would like to see your mom in Houston at a CV surgeon's office.  We can get her assessed.
answered Oct 27, 2012 by jlvarisco (2,070 points)
My email address is jlvarisco@tmhs.org
In June 2012 my mother's condition was life-threatening.  Her cardiologists performed what I call, in lay-man's terminology, a "balloon" procedure and opened the aortic valve to a certain degree.  It has already re-closed to a considerable degree.  It is thought by her primary cardiologist (he is one of three doctors involved in the clinical trial)  that she meets the criteria for admission into the clinical trial. When the Medtronics team (3 nurses) entered her hospital room for the first time, the first thing they said was: "You won't take blood, will you?"...Mother answered "no".  Then they stated that she would not qualify for the clinical trial because Medtronics required  permission to use blood if they deemed it necessary.  During the ensuing discussion (regarding our religious reasons for not using blood), one nurse stepped outside the room, called Medtronics and requested a waiver of this requirement.  He came back into the room and indicted that he expected the waiver to be granted.  It was not. The doctors will perform the balloon procedure only one more time. Then no options.

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