Request for Data Publication

 CFAAST
 

This is a large multi-center, prospective, randomized, partially blinded clinical trial, designed to determine whether mild intraoperative hypothermia results in improved neurologic outcome in patients with an acute subarachnoid hemorrhage (SAH), undergoing an open craniotomy to clip their aneurysms. To the best of our knowledge, this is the only NIH funded trial to examine the impact of an intraoperative intervention on neurologic outcome following any neurosurgical procedure. It is certainly the largest trial of its kind yet undertaken.

In this manual we have tried to cover all aspects of trial design and organization, participant and participating center requirements, training, eligibility rules, enrollment procedures, study protocols, form completion, data submission, etc. There is an enormous amount of material here. We strongly urge you to make this manual available to everyone in your PCC who will be involved - and to encourage him or her to read at least those portions that pertain to their activities. If you have questions, we ask that you first refer to the Table of Contents, or try searching for the relevant terms on the electronic version of the manual when it becomes available. However, please don't hesitate to contact the Clinical Coordinating Center (CCC)  ihast2@uiowa.edu or Data Management Center (DMC) ihast2@mail.public-health.uiowa.edu at Iowa with any and all questions that you may have, at any time.