ISSUE #1 - SAN DIEGO COUNTY
Recommended Action:
Receive updated information on the approval of San Diego County’s Trial Study on Hypertonic Saline Resuscitation Following Traumatic Injury.
Fiscal Impact:
None.
Discussion:
At the September 21, 2005 Commission meeting, you received information on San Diego County EMS Agency’s request for approval to conduct a trial study on Hypertonic Saline Resuscitation Following Traumatic Injury. The study is a collaborative designed study co-sponsored by the National Institute of Health, the National Heart, Lung, Blood Institute, the Department of Defense, and the Canadian Institutes of Health Research, and is proposed for implementation at the ten Resuscitation Outcomes Consortium study centers across the United States and Canada.
At that meeting, it was reported that on July 6, 2005, the EMS Authority granted approval for the study if the study is approved by the Food and Drug Administration (FDA) and the local Investigative Review Boards (IRB) of the five San Diego County trauma centers, and if San Diego County EMS Agency agreed to the following conditions: 1) The EMS Authority will be provided with the finalized research protocol prior to enrollment of any patients; 2) immediate notification [by phone or fax] will be provided to the Director of the EMS Authority of any occurrence of a serious adverse event related to the prehospital portion of the study; and 3) a written trial study progress report, including a summary of patient enrollment, all serious adverse events, and any correspondence between an IRB and the independent safety committee will be submitted to the EMS Authority every six months in lieu of the usual 18-month report.
On October 26, 2005, the EMS Authority received a response (copy attached) from Dr. Gary Vilke, Medical Director for the San Diego County EMS Agency accepting the conditions for approval of the trial study as outlined in the July 6, 2005 letter from then Interim Director Richard Watson. Dr. Vilke reiterated in his October 26 letter that the EMS Authority would be advised of the termination date of the Polyheme Trial Study following the initiation of the Hypertonic Saline Resuscitation Trial Study.
ISSUE #2 – SAN DIEGO COUNTY
Recommended Action:
Receive the 18-month report on the trial study: Protocol Number RTBSE-11-(N): A Phase III, Randomized, Controlled, Open-Label, Multicenter, Parallel Group Study Using Provisions for Exception from Informed Consent Requirements Designed to Evaluatethe Safety and Efficacy of Poly SFH-P Injection (Polymerized Human Hemoglobin (Pyridoxylated), Polyheme) When Used to Treat Patients in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Prehospital Setting. Recommend approval of the continuation of the study without modification for another 18 months.
Fiscal Impact:
None.
Discussion:
This study was approved by the EMS Authority on October 23, 2003. As you may recall, this was an industry-sponsored study and has been approved by the Food and Drug Administration. It was to be instituted in about 20 sites nationwide. The estimated duration of the study was two years to include enrollment and data analysis. The safety and efficacy of Poly SFH-P Injection was to be assessed in comparison to crystalloids in the prehospital setting, and in comparison to blood for the 12-hour post-injury hospital setting. It was anticipated that 720 patients would be enrolled in the study nationwide with 360 patients randomized to receive Poly SFH-P Injection (experimental group) and 360 patients to receive crystalloid in the prehospital phase and blood in the hospital phase (control group).
The study was initiated in San Diego County on May 20, 2004 with the Polyheme being carried on two air ambulances. On June 11, 2004, Polyheme was stocked on 7 ground ambulances, and on November 19, 2004, an additional agency was added to the study with Polyheme being carried on an additional 3 ambulances and 3 fire engines.
As of November 21, 2005, the Poly SFH-P Injection is being carried on 6 ambulances and 3 engines. Mercy Air changed airships and no longer had physical space for the cooler. As they have never enrolled anyone, it was decided to cease carrying the Poly SFH-P Injection on the aircraft.
To date, 21 patients have been enrolled in the study. All patients were enrolled utilizing appropriate use of the randomization process. There have been a total of four protocol violations, but none since the report in June 2005 (copy enclosed). All four of the protocol violations had been reviewed by Dr. Gary Vilke and none resulted in any adverse events with the patients. There were no complications as a result of the study protocol, nor were there any complications or adverse events in the care of the patients in the prehospital setting. There have been two reportable safety events occurring to patients while in the hospital since the June 2005 report: one was a pulmonary embolism and the other was a pneumothorax, neither of which appear to be related to the study drug. All patients enrolled have done well and are all alive at 30-day follow up.
The Independent Data Monitoring Committee for this study has recommended that the Phase III study with Polyheme continue without modification. Dr. Vilke has requested an 18-month extension of the study.
Enclosures
