CVAD occlusions or blockages due to formation of a blood clot (thrombus) within or at the tip of the CVAD catheter are a common problem that can block the administration of these therapies to patients.
The COOL efficacy trial, a Phase III, six-month, randomized, placebo-controlled, double-blind study, enrolled 150 adult and pediatric (ages 2-16) patients with CVAD occlusion up to 24 hours.
The study found that patients treated with up to two active doses had restored CVAD function.
The COOL-2 trial, a Phase IIIb, single-arm, open-label study, enrolled 995 adult and pediatric (ages 2-16) patients with CVAD occlusion present for any duration to determine the safety of Cathflo Activase for restoring function to occluded CVADs.
Following Abbott Laboratories' removal of urokinase from the CVAD clearance market in late 1998, Genentech began working with the FDA to bring Activase to the market for use in occluded CVADs.
Chemotherapy treatments for cancer patients, antibiotics for patients with severe bacterial infections, and supplements for patients at risk for malnutrition because they cannot receive nutrients via the digestive tract can all be administered through a CVAD.
When CVADs become occluded, administration of critical therapies must be delayed until the blockage can be cleared or the CVAD can be replaced.
Current treatments for CVAD occlusion include surgically removing and replacing the CVAD, which can be an uncomfortable, expensive and a potentially risky procedure for patients.