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  • To Recruit or Not to Recruit for a Clinical Trial
  • Sal Cruz–Flores

Ms. J. M. arrived at the emergency room about 11 A.M. in the morning with stroke symptoms in the left side of her body. According to routine procedure with these [End Page 68] patients our services were called via the “code stroke” system, to expedite her evaluation. She was a 65 year–old woman who the last time she was seen normal was about 7 A.M. the same morning. This fact is important as the only approved specific therapy for ischemic stroke is intravenous thrombolysis, which has to be administered within three hours from symptom onset or from the last time the patient was seen normal. To get to this point the patient has to be promptly evaluated to establish the time of onset, the severity of the stroke, exclude any contraindications for the use of thrombolysis and have a CT scan performed. All these steps were completed expeditiously but she was not a candidate for the approved treatment as she was clearly beyond the window of opportunity.

On evaluation Ms. J. M. seemed to be suffering a severe stroke affecting a large volume of the right hemisphere of her brain which causes very disabling impairment among survivors. The mortality of this condition is about 30% but might be higher if they develop brain swelling which occurs in many of these patients. The common scenario in most hospitals is that these patients do not receive thrombolysis and are admitted to the hospital for supportive care to avoid complications and start physical and rehabilitation services.

The options and the scenario change in a hospital like the one I practice in as there are more specific options than routine care otherwise offers. One option is the use of invasive interventions aimed at “de–clotting” the occluded intracranial vessel with devices inserted endovascularly through the femoral artery and navigated up to the occluded vessel within the skull. The rationale to use such devices is promulgated on the idea that opening the vessel increases the chance of having a good outcome by limiting the size of the stroke. The use of these devices was approved by the FDA as they are effective in opening the blood vessels however, the devices have not been shown to improve the outcome of stroke. The use of these devices has increased in the last few years and the increase use seems to parallel the appearance of a DRG code that permits the payment for the treatment. Suffice to say the payment for hospitals is considerable per procedure and therefore, they stand to gain financially from these procedures. Despite the uncertainty surrounding the use of these devices many of us feel that the use is justified considering the bad outcome many of these patients have when left untreated.

A second option available in our institution is the voluntary participation in clinical trials aimed at proving whether an intervention improves the outcome of the stroke. These interventions in some trials include the use of intravenous medications and in other trials, the use of the same intra–arterial devices that can be used outside a trial because they have been approved for another purpose (that of opening vessels). Most of these trials require the initiation of treatment usually within 6–8 hours depending on the specific study. Since Ms. J. M. presented within four hours from the last time she was seen normal, it was clear that she was not eligible to received intravenous thrombolysis but was eligible to be treated with an endovascular intervention or to participate in one of the clinical trials.

With these issues in mind my colleagues and I, but particularly myself, started struggling with what was the best decision for Ms. J. M. Why is it that we were struggling? For one, my colleagues were interventionalists and tended to favor the use of the endovascular devices. On the other hand, I was the physician in charge of her care, but I was also the principal investigator in these clinical trials testing treatments for stroke. It was obvious I also had a conflict of interests as I could potentially stand to gain...

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