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Late-breaking results of clinical trial on therapeutic endovascular cooling reported at TCT 2008
Date:10/14/2008

d in the inferior vena cava. As cool sterile saline is circulated within the catheter, blood flowing past the catheter is cooled and, in turn, reduces body temperature. To re-warm the patient, the sterile saline within the catheter is simply warmed.

In the COOL RCN trial, 136 patients were recruited between March 2006 and August 2007, and researchers were able to evaluate 128 patients. In the pilot study, 32 patients (median age 71, 50% diabetes) were hydrated and cooled to 33-34○C less than 90 minutes prior to and for 3 hours after contrast was administered. Cooling had to be achieved before the first administration of contrast agent. The target core temperature in patients was 33○C; no contrast was administered before 34○C.

The observed rate of RCN in the control arm - 18.6% - was lower than had been anticipated - 35%. This fact, coupled with the enrollment of only 136 of 400 planned patients (34%) resulted in a wide point estimate for the treatment effect of systemic hypothermia.

Dr. Stone noted the trial was abbreviated due to a lack of funding. However, he concluded that based on the limited number of participants, "in patients at high risk for RCN undergoing invasive cardiology procedures, cooling may be safely achieved and is well-tolerated, but these results do not point to a significant reduction in RCN."


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Contact: Judy Romero
jromero@crf.org
646-957-6898
Cardiovascular Research Foundation
Source:Eurekalert

Page: 1 2

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