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ROC Report Jan Vol No


									                                                                                                           January 2008 • Vol. I, No. 4


Enrollment/HS form changes                                          Q&A
                                                                                                                     SEATTLE, Washington

                                                                                                                 Hot Topics/Insites
            See page 2                                          See page 3                                             See page 4

                 Amendment 3
If the amendment is                             Under the amendment, we will                      sequela of traumatic head injury and not
                                              continue the required expedited                     thought to be associated with hypertonic
approved, the CTC will revise                 reporting of such unexpected SAEs as                saline.
the policy regarding the                      an anaphylactic reaction, hypernatremia
reporting of ICH in order to                  requiring treatment, seizure activity                 Hence, in this amendment we have
                                              associated with hypernatremia, and                  removed the wording suggesting that
remove the need for a written                                                                     expedited reporting is required for
                                              any other unexpected SAE reasonably
clinical summary.                             thought to be possibly associated with              increased intracranial hemorrhage

              he Clinical Trial Center
                                                                                                     If the amendment is approved, the
              (CTC) would like to advise
              all ROC investigators and         Please do not submit these                        CTC will revise the policy regarding the
                                                                                                  reporting of ICH in order to remove
              staff that we have recently       changes to your IRB until we
                                                                                                  the need for a written clinical summary.
reviewed the FDA regulations for the             receive approval from the                        The occurrence of the safety endpoint
reporting of unexpected serious adverse
events (SAEs), observed during the                         FDA.                                   will continue to be indicated on the data
                                                                                                  collection forms, with the aggregate data
conduct of the HSD study. To bring
                                                                                                  reviewed by the DSMB on a regular
the wording of the HSD protocol more
                                                                                                  basis along with all safety data and study
closely in line with the FDA regulations
                                              the administration of hypertonic saline             endpoints. Such a change will represent
for the reporting of SAEs, a third
                                              or hypertonic saline with Dextran.                  a significant time savings for both
amendment to the HSD protocol will
                                              Of special note, however, are the                   the RCCs and the CTC, as increased
be submitted to the FDA this month.
                                              planned changes in the reporting for                intracranial hemorrhage is observed in
In this amendment, we make clearer
                                              an observation of increased intracranial            about one-fourth of TBI patients. These
the distinction between expeditable
                                              hemorrhage. Though such a safety                    changes in reporting can not take place
SAEs that need to be reported rapidly
                                              endpoint continues to be of scientific               until we have received FDA approval for
to the FDA and the more routine
                                              interest in the study, the occurrence of            the amendment. Please do not submit
monitoring of certain safety endpoints
                                              this adverse event does not meet the                these changes to your IRB until we
that are frequent sequelae of the medical
                                              criteria of an unexpected SAE. It is                receive approval from the FDA.
conditions under study.
                                              instead known to be a frequent number

                         The Resuscitation Outcomes Consortium (ROC) provides infrastructure and project support for clinical trials and other
                         outcome-oriented research in cardiopulmonary arrest and severe traumatic injury. Mail: ROC Clinical Trial Center, 1107 NE
                         45th St., Suite 505, Seattle, WA 98105-4689. Telephone: (206) 685-1302. Email:
2                          ROCReport          January 2008
HS Enrollment
(data through January 21, 2008)
There were 30 TBI and 12 Shock patients enrolled last month ( December, 2007).

                                                                                                                                    Cohort TBD

      Number of patients


                           300                                                                                                      TBI


                           100                                                                                                      Shock

                                 ARC   DAL   IWA   MLW   OTT    PGH       PTL      SDG      SKC       TOR      VAN     Overall

HS form changes
                                                                                        pre-hospital form.
After much discussion on Trauma calls in November and
                                                                                      • Question 6b: “Electrolytes in the first 24 hours” data
December and with input from a coordinator committee,
                                                                                        table is sort-able; only highest sodium from hours 24
significant changes and improvements will be made to the HS
                                                                                        - 48 will be collected (highest chloride and potassium
data forms including the following:
                                                                                        fields dropped.
                                                                                      • Question 7: “Osmolality” pre-filled dates added.
   • Just one Alert CTC form will be required for the
                                                                                 NEURO FORM –
     “Intended to Enroll in TBI cohort” patient who had the
                                                                                    • Question 3: “Other interventions for intracranial
     exclusion present of “Isolated penetrating injury to the
                                                                                      hypertension…” Ventricular drainage data will no
                                                                                      longer be collected.
   • Wording added to specify Mannitol as an exclusion.
                                                                                    • Question 5b: Sodium levels Day 0-5 data table is
   • Question 1- “Vital signs”: Only those patients who are
                                                                                 HOSPITAL FORM –
     in “Both” cohorts (as stated on the enrollment form)
                                                                                   • Question 3 - “Infection”: Infecting micro-organism
     will be asked to enter both the ‘Qualifying GCS’ AND
                                                                                     identification dropped.
     “Qualifying SBP prior to study fluid”.
                                                                                   • Question 9: “Was TBI outcome interview
   • Question 2 - “Procedures”: Added “King Airway”.
                                                                                     administered prior to discharge?”. This field now not
   • Question 4 - “Fluids given”: Crystalloids totaled in one
                                                                                     accessible to Shock only cohort subjects (based on
     data field; Added a query about pre-hospital Mannitol
                                                                                     data entered on the Enrollment form).
                                                                                 DISCHARGE TBI OUTCOME INTERVIEW FORM –
                                                                                    • Question 2: Added a field to indicate the interview
   • Question 2: Demographics “Birth year” – now an over-
                                                                                      information was collected from chart review (to be
     ride-able field.
                                                                                      used as a last resort).
   • Questions 3 and 4: Added pre-filled date/time
                                                                                 These forms changes will be implemented in January and
RESUS/INJURY FORM –                                                              February. The changes will result in easier data entry, less
   • Question 5 - “Fluids”: All fluids collected as a single 24                   data collected on some forms and fewer over-rides needed
     hours period, all crystalloids now grouped together; mls                    over-all. A refresher class on using the HS web forms is
     of study fluid added as a prefill from the Enrollment                         planned for February.
     form, Mannitol (if given) will also be prefilled from the
    REACH THE ROC • Phone (206) 685-1302 • Fax (206) 543-0131 • E-mail • Help •
3        ROCReport                    January 2008

                                                 Q & A
Should the medics enroll a patient whose VS make                              Can you please clarify this statement from the HSD
him eligible for HS enrollment when first assessed,                           inclusion criteria:
but by the time he is extricated his vital signs have                         “Patients with both a GCS ≤ 8 & who meet the
improved enough so that he no longer meets                                    criteria for the hypovolemic shock cohort will be
inclusion criteria?                                                           considered part of the hypovolemic shock cohort
  This patient should not be enrolled. The most recent                        but will have assessment of neurologic outcome for
assessment of VS should be used when deciding whether                         subsequent subset analysis.”
or not to enroll a patient EXCEPT when the enrolling air-                     Does this statement only refer to patients who
med team arrives to transport a patient who has already                       meet both cohort criteria? In other words, they
been intubated by the ground EMS. In this scenario the                        must have blunt trauma?
patient can be enrolled into the TBI cohort based on the
pre-intubation GCS documented by the ground EMS.                                Correct, to be considered for the TBI cohort they must
(Encourage your medics to leave the outer wrapping on the                     have had blunt trauma. This means that a patient with
                                                                              penetrating injuries only would not be considered as having
fluid until the patient is able to receive the fluid. If they
                                                                              met the TBI criteria even if their GCS is ≤ 8, and no TBI
do remove the outer wrapping they should not administer
                                                                              outcomes or neuro forms would need to be completed.
unless the patient is eligible. Better to have a BONG (Bag-                   Confusion over this issue prompted a change in August
Opened-fluid-Not-Given) patient than an inappropriately                        2007 to the Enrollment form: Question 4: Inclusion
enrolled patient.)                                                            criteria: TBI cohort which now reads ”Blunt Head Trauma
                                                                              leading to ….”
If patient is discharged home quickly, how
important is the TBI interview? Can admit clerks
                                                                                In a blunt injury scenario where the patient meets the
do this? Can TBI interview for these patients be                              shock criteria and has a GCS ≤ 8, both criteria have been
completed from the chart?                                                     met. This patient’s primary outcome will be the 28 day vital
   The discharge TBI outcome interview gives us a valuable                    status, and the TBI outcome measures would be collected as
 baseline to use as a comparison with the 6 month TBI                         secondary outcomes.
 outcome interview (primary outcome). Training is required
 to understand how to correctly administer the interview.                       Please note that Shock only patients who have an
                                                                              incidental finding of a positive head CT (Marshall score
 The HS forms are being changed to allow the discharge TBI
                                                                              >0) will need to have the Neuro form completed for
 outcome information to be extracted from the chart in those
                                                                              safety monitoring, but no TBI outcome measures will be
 (hopefully rare) instances where the leaves prior to having                  collected.
 the discharge interview completed by the site coordinator.
 THIS IS TO BE USED AS A LAST RESORT -- the in-                                Is the development of an intracranial hematoma
 person interview is the preferred method to gather this                       considered a reportable SAE at any point during a
 information.                                                                  patients hospital stay?
 I have a long stay TBI patient who had pneumonia                                 No, we track evidence of increased bleeding shown on
 early on that cleared up but now it looks like he                             the first three head CT’s done within the first week of
 may qualify again for pneumonia. Do I need to                                 hospitalization. This lets us track events that are more
 record it twice in the hospital form?                                         likely to have temporal relationship to the administration
                                                                               of the study fluid and keeps us from tracking iatrogenic
   If it is indeed a second infection, you should enter it                     injuries unrelated to the initial injury episode (like the
 again. But NOT if it is just a continuation of the first                       patient who falls out of bed on day 18 of their hospital
 infection (due to failed treatment for example). Look at the                  stay and cracks their noggin). When in doubt about
 micro report, consider the timing and, when in doubt, ask                     whether or not to report an event, please check with your
 your local investigator to weigh in.                                          PI or call the CTC.

   REACH THE ROC • Phone (206) 685-1302 • Fax (206) 543-0131 • E-mail • Help •
4          ROCReport                    January 2008

Hot Topic
Mannitol is an exclusion to enrollment in HS
It was recently clarified that the use of Mannitol prior to administration of the HS study fluid is exclusion to enrollment. A
poll revealed that out of the seven ROC sites that have an air-medical agency enrolling HS patients; only 5 carry or administer
Mannitol and no ground agencies carry this drug.

                                                                                                         MARK IT ON YOUR
“INSITES”  Tips from your colleagues
    Following the October 2007 steering committee meeting in Chicago                          DSMB MEETING ON APRIL 30, 2008:
coordinator facilitator Tyrone Perreira surveyed the site coordinators
about the challenges and successes they face implementing the HS study.
                                                                                              • MARCH 10, 2008 - episodes through this
                                                                                                date will be included
This sparked a good discussion on a subsequent coordinators call and gave
sites a chance to share their many good ideas (and air some grievances                        • MARCH 19, 2008 - second set of primary
– also therapeutic). Many sites face similar challenges (local politics, strict                 outcome spreadsheets to sites
and or skittish IRB and REBs, staffing issues, restricted training times, etc)                  • MARCH 24, 2008 - data cutoff-all data due
and benefit by hearing how others meet challenges locally. Below are some                        should be entered for March 10 cases
of the great strategies for success the coordinators have come up with:                       • APRIL 22, 2008 - materials to the DSMB
    • Meet every patient before they leave the hospital
    • Get a contact for every person in the room-sister, brother, friend etc                  STEERING COMMITTEE MEETINGS:
    • Persistence and perseverance                                                            •  MAY 1-2, 2008 - Bethesda, MD.
    • Try calling in the evenings and from a non-hospital phone                               • OCTOBER 2008 - Vancouver, B.C.
    • Use coroner’s office to obtain next-of-kin information
    • Add notification of study personnel to the discharge orders. That                                    KUDOS KORNER
      way you’ll always be notified when the patient is leaving (especially
      important for administration of the discharge TBI outcome                               • Thanks for the tons of effort expended by
      interview)                                                                                  everyone to increase capture of primary
    Study visibility                                                                              outcomes in the last several months – your
    • Personalized “Thank you!” letter to enrollers signed by Investigators                       hard work has made a difference!
    • Develop working relationship with paramedic colleges; building in
      research lectures into curriculum                                                       • Pittsburgh has received IRB approval for the
    • Chat with medics to increase awareness                                                      HS study at its third (and final) receiving
    • Signs and posters (in hospitals and at agencies/stations)                                   hospital enabling them to use their ground
    • Think HS stickers on kits in the EMS vehicles                                               agencies to enroll.
    • Community: Go to festivals and large events; hand out flyers; chat
    • Newsletter                                                                              • Bernie Dornato, the new coordinator from
   Communication                                                                                  the University of California, Irvine is working
    • Go out to stations and speak with medics                                                    hard to get the HS study approved for the
    • Frequent calls with the CTC                                                                 expansion to Orange County!
    • Use university mass mailing system for public notification and
      community consultation                                                                  • Many thanks to the coordinators who helped
    • Get base hospitals, ED physicians and trauma team involved; if they                         review and evaluate the HS data forms
      speak to the medics and ask if they enrolled patients paramedics feel                       pursuant to the discussions about decreasing
      like part of the team                                                                       the data burden – your insight was very
   Resources                                                                                      valuable!
    • Form a volunteer program to get paramedic students and graduates
      to commit to regular hours; students benefit by getting experience                       • Alabama had the first successful
      and reference letters                                                                       follow-up via email – way to use
    • Employ paramedic, nursing and medical students                                              modern technology!
     REACH THE ROC • Phone (206) 685-1302 • Fax (206) 543-0131 • E-mail • Help •
5        ROCReport                  January 2008

Not just used in the manufacture of HS, HSD and NS…….

•   Salt has been used as a food preservative for centuries. The phrase to “salt away” has come to be synonymous with these
    verbs: accumulate, amass, bank, cache, hide, hoard, invest, lay aside, lay away, lay by, lay in, lay up, put away, put by, save,
    set aside, spare, stash, stockpile, store.
•   At certain points in history salt has been considered valuable enough to be used as a form of currency in some societies.
•   “Salt of the earth”, meaning a person of great goodness, is one of over 30 phrases involving salt used in the bible
•   The word “salary” comes from the Roman times, when soldiers were given an allowance to buy salt
•   Until the late 19th century, salt bars called amoleh were the standard currency of Ethiopia.
•   In Ancient Egypt, slaves were traded for salt, hence expression “not worth his salt”.
•   If we are skeptical about a fact, we might “take it with a grain of salt”, which you might want to do
    when considering this advice: cream whips better when a pinch of salt is added.

                                                      FEBRUARY 2008
    Sunday             Monday               Tuesday             Wednesday              Thursday                Friday              Saturday
                                 28                     29                    30      31                                   1                  2
                                                           Trauma Times  TBI Outcome
                  EMS Structures                                         web conference
                  Survey II Call                           WG Call       Call
              3                    4                     5             6               7                                   8                  9
                                                                         Cardiac Call
                Agenda Planning
                Call                                                                PI Call
             10             11                           12     13              14                                        15                  16
                                                   Study Monitor-
                                 Trauma Call       ing Call
                                                   Epistry Call
             17               18               19               20              21                                        22                  23
                President’s Day- Publications Call Coordinator’s   Cardiac Call
                CTC closed                         Calls           PI Call
             24               25               26               27              28                                        29
                                 Trauma Call

                          The Resuscitation Outcomes Consortium (ROC) provides infrastructure and project support for clinical trials and other
                          outcome-oriented research in cardiopulmonary arrest and severe traumatic injury. Mail: ROC Clinical Trial Center, 1107 NE
                          45th St., Suite 505, Seattle, WA 98105-4689. Telephone: (206) 685-1302. Email:

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