Research Protocol Consults Community

Contact: Amanda White

Photo of Andrew Bernard, M.D.
Andrew Bernard, M.D.

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The following is a list of dates, times and locations of the community meetings in each of the counties that would be participating in this study:

Feb. 20, 2004, 10:30 a.m.,
Lexington Community Meeting

H611, Auditorium, UK Hospital, Rose Street, Lexington

Feb. 26, 2004, 5:30 p.m.,
Georgetown/Scott Community Meeting

Scott County Fiscal Court, Courthouse, Main Street, Georgetown

March 1, 2004, 6 p.m.,
Bourbon County Fiscal Court/Community Meeting

Bourbon County Courthouse, Main Street, Paris

March 2, 2004, 9 a.m.,
Anderson County Fiscal Court/Community Meeting

Anderson County Courthouse, Main Street, Lawrenceburg

March 2, 2004, 6:30 p.m.,
Richmond/Madison Community Meeting

Madison County EMS Station 3, 556 South Keeneland Dr., Richmond

March 4, 2004, 6 p.m.,
Winchester/Clark County Community Meeting

Clark County Extension Building

March 8, 2004, 7 p.m.,
Lawrenceburg City Council/Community Meeting

City Hall, 205 Woodford St., Lawrenceburg

March 9, 2004, 7 p.m.,
Woodford County Fiscal Court/Community Meeting

Courthouse, Main Street, Versailles

March 11, 2004, 5:30 p.m.,
Nicholasville City Commission/Community Meeting

City Hall, 517 N. Main St., Nicholasville

March 16, 2004, 4 p.m.,
Jessamine County Fiscal Court/Community Meeting

Courthouse, Main Street, Nicholasville

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LEXINGTON, Ky. (Feb. 19, 2004) -- University of Kentucky researchers are seeking community feedback about a proposed research study to investigate the use of a potential blood substitute in treating severely injured and bleeding patients. The researchers are launching a program to explain how patients would be enrolled in the protocol and to solicit community feedback on those plans.

The study would be conducted under a federal regulation that allows research to be conducted in certain emergent, life threatening situations using an exception from the requirement for informed consent. In proposing conduct under this “exception from informed consent,” the federal regulation requires community consultation to ensure that the community is involved in the University’s Medical Institutional Review Board’s (IRB) decision-making process.

Andrew Bernard, M.D., trauma surgeon, UK Hospital, faculty member, UK College of Medicine, Department of Surgery, would be the principal investigator of the Central Kentucky-area portion of the national clinical trial testing PolyHeme®, an oxygen-carrying blood substitute being developed by Northfield Laboratories, in the treatment of hemorrhagic shock.

Trauma patients who have lost massive amounts of blood display dangerously low blood pressure and are at risk of organ failure and death due to oxygen deprivation. Northfield Laboratories proposes to enroll 720 patients in the nationwide study, which will last approximately one year. If the study takes place at UK, Bernard expects to enroll 40 to 50 at this location.

Bernard and members of the research team will present the protocol information and field questions at a series of meetings with a variety of groups designed to be representative of the counties involved in this trial (Lexington/Fayette, Anderson, Bourbon, Clark, Jessamine, Madison, Scott, and Woodford counties). Bernard’s team will report back to the UK Medical IRB, which will have the final say on whether the protocol proceeds.

In the research protocol, trauma victims who are transported by emergency medical services from participating counties, who are at least 18 years old, and who have a systolic blood pressure less than or equal to 90mmHg would be eligible for the study. While in route to the hospital, participants would receive either the usual saline solution to boost blood pressure (control group) or PolyHeme.

Once at the hospital, control group patients would receive saline for hydration and blood transfusions as needed to boost oxygen levels. Those on PolyHeme would receive saline for hydration and up to a total of six units of the blood substitute during the first 12 hours. Blood transfusions would be used after that. All trauma victims given PolyHeme must be treated at the University of Kentucky.

Under the study’s protocol, those who do not wish to participate would be able to opt out by obtaining a bracelet from study coordinators, similar to other medical alert identifiers.

About two million Americans suffer trauma-related injuries each year; trauma is the leading cause of death among those under 45 years old. Shock patients routinely receive saline solution for hydration in the field and then have their blood typed and matched for transfusion at the hospital.

“The potential benefits of using the oxygen-bearing blood substitute in the pre-hospital setting is to boost oxygen levels earlier in treatment, which could protect major organs and improve patient survival rates,” Bernard said.

Federal law permits enrollment of patients without consent if the IRB finds and documents that the following conditions have been met:

1. The potential subject cannot give consent because of a life-threatening medical condition and available treatments are unproven or unsatisfactory.

2. The intervention must be administered before consent from the potential subject’s legally authorized representative is feasible.

3. Participation in the study must offer the possibility of direct benefit to the subject, and standard treatment must also be provided.

4. Risks of the study are reasonable in relation to what is known about the medical condition of the potential subjects, the risks and benefits of standard therapy, and risks and benefits of the proposed therapy.

5. The clinical study could not be practically carried out without the waiver.

Efforts are made throughout the process to notify family members of study enrollment. Family members would be offered the choice of allowing the patient to continue in the study or withdraw. If they choose to withdraw, there would be no disruption in care or harm to the patient.

The community meetings will explain the purpose of the study, risks and benefits of the research therapy, and the fact that patients would be enrolled without informed consent, under the exception from informed consent regulation. Meeting participants will have an opportunity to ask questions and provide feedback. During the meetings, a brief questionnaire also will be distributed to obtain written comments. Information about a telephone hotline, e-mail address, and Web page will be distributed for additional contact with the research team.

For additional information:
PolyHeme hotline: (859) 323-6346 ext. 248
Web site
E-mail address: polyheme@uky.edu

The following is a list of dates, times and locations of the community meetings in each of the counties that would be participating in this study:

Friday, Feb. 20, 2004, 10:30 a.m., Lexington Community Meeting
H611, Auditorium, UK Hospital, Rose Street, Lexington

Thursday, Feb. 26, 2004, 5:30 p.m., Georgetown/Scott Community Meeting
Scott County Fiscal Court, Courthouse, Main Street, Georgetown

Monday, March 1, 2004, 6 p.m., Bourbon County Fiscal Court/Community Meeting
Bourbon County Courthouse, Main Street, Paris

Tuesday, March 2, 2004, 9 a.m., Anderson County Fiscal Court/Community Meeting
Anderson County Courthouse, Main Street, Lawrenceburg

Tuesday, March 2, 2004, 6:30 p.m., Richmond/Madison Community Meeting
Madison County EMS Station 3, 556 South Keeneland Dr., Richmond

Thursday, March 4, 2004, 6 p.m., Winchester/Clark County Community Meeting
Clark County Extension Building

Monday, March 8, 2004, 7 p.m., Lawrenceburg City Council/Community Meeting
City Hall, 205 Woodford St., Lawrenceburg

Tuesday, March 9, 2004, 7 p.m., Woodford County Fiscal Court/Community Meeting
Courthouse, Main Street, Versailles

Thursday, March 11, 2004, 5:30 p.m., Nicholasville City Commission/Community Meeting
City Hall, 517 N. Main St., Nicholasville

Tuesday, March 16, 2004, 4 p.m., Jessamine County Fiscal Court/Community Meeting
Courthouse, Main Street, Nicholasville


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