Travis County Commissioners Court
October 28, 2008
Item 2
Item no. 2 is next. 2. Receive comments regarding request for resolution in support of the rapid anticonvulsant medication prior to arrival trial (rampart), a comparison of two fda approved treatments for seizures.
>> move to open the public hearing.
>> all in favor? That passes by unanimous vote. Commissioner eckhardt temporarily away. Good morning. If you would give us your names, please, tell us what this is about. I'm dr. Tilling and I direct the research in the emergency department. To my right
>> [indiscernible] also with the research office at brackenridge.
>> okay. Welcome.
>> thank you for this time today, we just wanted to tell you briefly about this trial that we're -- we're planning to start early next year. Ram part is a prehospital comparison of two seizure drugs. It's part of a larger research effort that the university medical center at brackenridge, we have over 200 research projects in process right now. Everything from snake bites to using ultrasounds machines on helicopter to clinical trials of pharmaceuticals to a prehospital trial comparing two drugs that have long been f.d.a. Approved for treating seizures against each other. One by a intra muscular and one by intravenous injection. This study links us up with the national inh network of research called the neurological emergency network treatment trials network. It's the only way to do a trial that requires enough patients to find meaningful differences between groups. For a condition that just doesn't have the volume at any one center. So the national institutes of health has funded this network of centers to do these projects. We were honored to be asked to be a part of that. Because of a seizing patient can't at the time that e.m.s. Arrives give consent to be enrolled in a research study, an issue called exception to informed consent comes into play. So -- so arguably the people with acute medical conditions often traumatic, seizure or some other acute condition can't give consent, it's a feeling in the f.d.a. And the nih that there should be some process in which we could still do research in this patient group. Arguably the sickest patients deserve the best research. So the idea of ethics or exceptions from -- in informed consent was created. There's a community
>> [indiscernible] arm to that, which requires us on the front end to perform due diligence to inform everyone who is likely to be involved in that study about what we're doing, give them opportunity to opt out, if you will. We -- this is part of that process, being with you here today. And we have an opt out program or opt in, which we are all wearing the opt in bracelets. And they just contact us, we can give them a bracelet that they can wear, which would immediately exclude them from the study. Also when these patients wake up in the hospital, they can opt out at that point as well. And this is the sort of balancing the individual's rights with -- with the community's need for the best research in this patient population. Seizures often are self limited but occasionally can be perceived at status epilipticus which can be life threatening, seizures won't stop. In those cases determining which medication is best is the life and death. The primary objective of the study is to find out whether they are equal or better, also administering time of e.m.s. Arrival to administration of the drug, other time intervals, following them briefly in the hospitals as well. Okay. Okay. So we wanted to bring this protocol to you in advance of enrolling anyone in the study as parts of a community consultation, public awareness campaign. To -- to answer any questions that anyone might have about this study. And to emphasize the importance of the research to our community and many others across the country. The importance of brackenridge as a research center and asset to the community.
>> so in addition to public education today, you're asking the Commissioners court to do what?
>> we are asking for a resolution in support of the -- in support of the research protocol. To -- to show that -- that you had representation of your constituents believe this as we do, that this is important research for our community.
>> and the purpose of the research again?
>> is to compare two drugs for seizure. These drugs long approved by the f.d.a., there's no pharmaceutical industry influence on the study because both are in again rick form, there's -- generic form, there's no interest in profiting from either drug. It's purely a research question of which drug is better.
>> okay. The city of Austin already approved the resolution.
>> they have indeed.
>> are you asking any other public or private entities for support?
>> well, we are happy to have lewis hernandez here with the Austin Travis County e.m.s. Of course they are essential to this effort since it does enroll patients in the pre hospital environment.
>> okay. Questions?
>> just briefly, doctor. Without the community consent, individuals who are having seizure would get one of these two drugs in any case, correct?
>> true. It's sort of depends on where you are. I mean, these drugs are approved and carried on different ambulances in different systems. So that you might get one drug in san antonio and another one here or either one depending on which ambulance responded.
>> so in terms of -- of a change in treatment, whether community consent is provided by this body or not, individuals would still get one or the other of these drugs, we just wouldn't have the research basis to know which was optimal under the circumstances.
>> that's well stated. The incremental risk of formalizing this into a study to find out the important question of which one is better doesn't -- is minimal if at all to the patient who has the seizure.
>> and when it -- my understanding from my conversation with you is that when the -- when the patient does recover from the seizure, they are then asked whether they want to remain in the study or not. So at the earliest convenience the individual is consulted.
>> actually the second they are awake, they can opt out of the study immediately and no further data will be collected.
>> okay. Thank you.
>> uh-huh.
>> we are posted for public hearing. Would anyone like to give testimony during this public hearing? If so, please come forward.
>> move to close the public hearing.
>> second.
>> all in favor? That passes by unanimous vote.
>> thank you, doc.
>> thank you very much. We will recommend that the action be taken as parts of the consent motion today. We will get that resolution to you.
>> thank you very much.
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Last Modified:
Tuesday, October 28, 2008 1:38 PM