Microsoft word - alias2 june 2011 newsletter.doc

June 2011 Newsletter
The ALIAS 24-Hour Emergency Phone Number is
1-866-99-ALIAS (1-866-992-5427)
As of June 30, 2011 Total enrollment is 537.
1 new clinical site has enrolled subjects since the Contacts
Baylor College of Medicine
Suarez/Calvillo
STUDY CHAIR OFFICE (SCO)
Spotlight On
University of North Carolina
Chapel Hill , NC
PI: David Huang, MD
SC: Sierra Marino
Isabel (Isa) Mendez – Financial Manager The University of North Carolina Stroke Center is located in the heart of the USA’s “Stroke Belt”, in Chapel Hill, North Carolina. But they will tell you they are located in the “Southern Part of Heaven.” The program was established in 2002, bringing leading-edge research, ACGME vascular neurology fellowship CANADIAN COORDINATING
training, quality treatment and preventive care to the citizens of CENTER (CCC)
Led by David Huang, MD, PhD, the Stroke Center's multidisciplinary care approach utilizes the expertise of Stroke and Neurocritical Care Neurologists and other physicians and staff with specialty training in the treatment of stroke and TIA, including emergency medicine physicians, neurosurgeons, neuroradiologists, cardiologists, vascular surgeons, physiatrists (rehabilitation medicine), and stroke ancillary care specialists (physical therapists, occupational therapists, speech therapists, respiratory therapists, and social workers). Acute stroke care is provided to medically eligible patients by an on-call Acute DATA COORDINATION UNIT
Stroke Team that coordinates acute treatments, such as intravenous thrombolysis and interventional procedures. The Team also screens patients for inclusion in clinical studies and trials of the experimental stroke therapies. By demonstrating a strong track record of quality and excellence in stroke care, the UNC Hospitals Stroke Center has maintained Disease-Specific Care Certification in Stroke and the Gold Seal of Approval™ from the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) since 2004. UPDATES AND REMINDERS
AE/SAE Updates
Once an AE or SAE has been entered into WebDCU, there may be a need to make an update to the information entered. Either adding new information (such as additional treatments found in a chart review), or correction/expansion of data entered, or identifying follow up data (such as a change in Outcome from Continuing to Resolved with a resolution date), has three For an SAE which has not completed the review process, a ALIAS is funded by a cooperative Data Edit button will be available which allows editing of all
data entered as well as addition of more information.
For a SAE that has been through the review process, the same
can be accomplished by clicking on the Data Error Correction
button which allows editing of all data entered as well as
addition of more information.

The third option is meant only for adding additional follow up
information, and gives access to a limited set of data fields.
This button is labeled Create Follow Up AE, and should only
be used for follow up information.
If it is necessary to change the status of a SAE to an AE, or an AE to a SAE, you must use one of the first two options. This change cannot be accomplished by use of the Create Follow Up AE button. Although we want you to be thorough and accurate in reporting AEs and SAEs, you do not have to edit, correct, or follow up for typos or inconsequential omissions in the initially reported AE or SAE. Recording Fluids on Form 22

There are three primary considerations for correctly entering
data on Form 22: Weight, Fluid Monitoring & Diuretic Use. First, all time frames start from randomization (opening the kit). Therefore, the reporting periods are randomization to 24 hours; then 24 hours to 48 hours post randomization. Second, the question regarding administration of 20mg IV Lasix or other diuretic between 12 and 24 hours refers to the protocol-mandated diuretic administration. As provided for in the protocol, however, it is acceptable to withhold the diuretic if the treating physician believes this is the best course of action. In this situation, the CRF must contain an explanation of why the diuretic was not administered. Third, the protocol-mandated diuretic should be listed in Section 14 of Form 22 as a diuretic administered, even though you have already indicated that it was administered in Line 11 of Form 22. Listing it in Line 11 indicates that you are protocol compliant and listing the date, time, and dose in Section 14 includes that dose in the cumulative total of diuretics administered within the first 48 hours. transfer of care In the ALIAS-2 trial, we are strongly advising a maximum IV fluid administration of 4200 cc over 48h over and above study medication and tPA. We are asking you to report on the total fluid administered during that first 48h. The purpose is to limit the evolution of pulmonary edema/congestive heart failure. The majority of cases are following this guideline easily; the guideline is not followed in complex cases and often when there is a transfer of care between treating teams. Emergency --> Intensive care or Stroke Neurology --> intensive care. Please ensure that you communicate with the attending team. Explain the guidelines around fluid conceptually as a test of high dose human serum albumin (2g/kg over 2 hours) vs. saline control over and above the best standard of care. The best standard of care, however, varies among sites. Recently we have seen use of several unapproved medications and approaches for ischemic stroke. For example, the use of GPIIbIIIa inhibitors in stroke is completely unapproved and is associated with increased risk of symptomatic ICH. While our trial is philosophically designed to allow for the evolution of stroke care, we strongly encourage you to stick with what is known to work. Your best standard of care should be the proven standard of

Source: http://webdcu.musc.edu/alias2/NewsLetter/NL1106.pdf