RE: A wrist band that indicates that substitute blood is not to be used on a patient?
I read about a substitute for blood that was used in some hospitals on a
trial basis. Unless the patient was wearing a wrist band that indicated
that the substitute blood was not to be used, the hospital had a legal
right to use the artificial blood without notifying the patient.
Where can these wrist bands can be obtained?
google "artificial blood" and there is an article about it from CNN.
This article is from 2004. I can't find the more recent article that mentions the wrisbands.
Information just found. PolyHeme produced by Northfield Labs in Northfield,Illinois.
- artemisaodc1Lv 41 decade agoFavorite Answer
I read about this. There were clinical trials going on in certain cities. In those cities only, one had to get a wristband if one did not want to receive the substitute blood products. I didn't happen to live in those cities, so I didn't need the bracelet. I believe that the studies may have been halted due to the media attention, but I will try to find the article for you to confirm. It was rather shocking.
Here's what the Brown University website says about thePolyHeme controversy:
This Phase III study has caused controversy among bioethicists, however, due to the fact that those participating in the study never give consent. Northfield Laboratories, Inc., states that due to the nature of the injuries being treated, the patients are unable to give consent and the study is therefore being conducted under a special section under the Code of Federal Regulations. Section 50.24 allows for the exception of informed consent under circumstances of emergency research when the medical condition of the patient requires immediate care, available treatments are unsatisfactory, previous studies demonstrate the potential to provide a direct benefit to the patient, and the risks are reasonable given what is known of the patients’ medical condition. Opponents of this study point to the fact that patients never get a chance to refuse the experimental blood substitute as automatic grounds for its discontinuation. Also, this provision for emergency research without informed consent, which was passed in 1996, was used as means to launch a Baxter Healthcare study in 1998. The study, which was the first major study of artificial blood, was cut short with disastrous results as almost half of the 52 patients died. In order to avoid criticism, the hospitals conducting this study have mandatory community meetings to educate the residents about the trial. Despite the fact that most residents do not object to the study, only one in 57 objected at the Loyola University Medical Center in Illinois, some medical centers have devised ways to allow residents to opt out if they want. For instance, at the Denver Health Medical Center, people who object for religious or other reasons can wear a bracelet that indicates their preference. This method has come under scrutiny, however, with many ethicists, most significantly Vera Hassner Sharav, president and founder of the New York-based Alliance for Human Research Protection, claiming that the burden should not be placed on those who do not wish to participate in the study, but rather on those who will. While the bioethics community remains divided on the issue, the Food and Drug Administration stands by their decision to allow the Phase III trial.
Nothfield Laboratories has also come under criticism for targeting minority and low income neighborhoods for the study. For instance, in San Diego, only ambulances working south of Interstate 8, a traditionally bad neighborhood, were equipped with Polyheme. Devon Price, the company’s spokesman, claimed that the company wanted to perform the study in neighborhoods with high rates of traumatic episodes. Opponents, however, point to the fact that in many neighborhoods with the study, ads were supposed to be posted in newspapers and on television indicating the nature of the study and ways to opt out, but never were. The only notice in San Diego was an obscure link on a UCSD website. Human rights activists also say that by performing the study in low income neighborhoods, the company is trying to protect itself because if anything does go wrong, the residents are not in a position financially to sue for damages.
In addition to patients’ rights problems, Northfield Laboratories has had to deal with some disturbing results as of late. In May 2005, researchers at Walter Reed Army Institute of Research performed an experiment comparing the safety and efficacy of resuscitative fluids in treating hemorrhaging lab rats. The results indicated that Polyheme may not be as safe as previously thought, with the data indicating that rats being treated with PolyHeme experienced higher mortality rates than those that received two commonly used solutions.
For a list of sites participating in the Phase III PolyHeme study, go here:
- 1 decade ago
'Opt-out' bracelets distributed for blood substitute
The University of Kansas Hospital and Medical Center is sending about 75 “opt-out” bracelets, for area residents who don’t wish to participate in the PolyHeme® trial.
The trial, which will include participants in Wyandotte, Leavenworth and Douglas Counties, will evaluate the safety and effectiveness of PolyHeme®, a temporary oxygen-carrying red blood cell substitute, in treating critically injured and bleeding patients.
Under the study protocol, treatment would begin before arrival at the hospital, either at the scene of the injury or in the ambulance, and continue during a 12-hour post injury period in the hospital.
Because the patients eligible for this study are unlikely to be in condition to provide informed consent for the trial, due to the extent and nature of their injuries, the study will be conducted under federal regulations that allow for clinical research in emergency settings using an exception from the requirement for informed consent.
Residents in Wyandotte, Leavenworth or Douglas Counties can request an “opt-out” bracelet at no cost at anytime during the trial. The wristband means the person desires not to participate in the study, thereby guaranteeing they would not receive Polyheme® in a trauma situation. The wristbands can be obtained through the KU websites: www.kumc.edu/polyheme/ and www.kumed.com or by calling the study coordinator, Suzanne Porras, R.N. at (913) 588-3005.
P.S> Thanks for the info... I hope I was able to help you too.
- 1 decade ago
They have a synthetic builder to blood that is used in operation sometimes when alot of blood is needed however I do not believe they will just give it to you unless you are in dire need of it. I also do not believe that they will give it to you without consent (unless of course in an emergency situation).Source(s): My mom is a head nurse in MS.
- 1 decade ago
May I ask where you got your information from?
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- 1 decade ago
i dunno but why? this is the US not China we only use stuff that we know is 100% safe
P.S i saw the story its only in one hospital in one city...