SOLICITATION NOTICE
A -- REQUEST FOR INFORMATION - Massive Transfusion Prospective, Multicenter Trial Data Coordination Center
- Notice Date
- 12/11/2007
- Notice Type
- Solicitation Notice
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-08-ISR-RFI
- Response Due
- 1/2/2008
- Archive Date
- 3/2/2008
- Point of Contact
- Kathryn McCune, 301-619-1354
- E-Mail Address
-
Email your questions to US Army Medical Research Acquisition Activity
(kathryn.mccune@det.amedd.army.mil)
- Small Business Set-Aside
- N/A
- Description
- QUESTIONS DUE: 0900 EST, 20-Dec-07. COMMENTS and CAPABILITIES STATEMENT (5 pages maximum) DUE: 0900 EST, 02-Jan-08. Responses to this RFI should be directed to: Kate McCune, kathryn.mccune@us.army.mil. REQUEST FOR INFORMATION (RFI) Introduction: T he purpose of this RFI is to survey the market and determine the appropriate direction in obtaining this type of support. Submission of a capabilities statement should be no more than a maximum of 5 pages. Comments regarding this requirement are not includ ed in the page limitation. Please identify all submissions with the solicitation number W81XWH-08-ISR-RFI. REQUIREMENT INFORMATION: The purpose of this announcement is for the establishment of a Data and Coordinating Center (DCC) to provide the necessary infrastructure to conduct a collaborative trial to identify the optimal blood component resuscitation ratios for patients receiving massive transfusion. Up to twenty-five centers will participate in this study as part of the Multi-Center Consortium (MCC) to correlate transfusion practices and blood component ratios. These centers have already been collaborating on a retrospective review of this topic, and the DCC is required in order to advance to a prospective data collection phase. Only 5-10% of all co mbat casualties require massive transfusion (10 units of PRBCs), but this group constitutes those most at risk for hemorrhagic death. In Iraq and Afghanistan, a 1:1 ratio of plasma to PRBC known as damage control resuscitation (DCR), started within minutes of arrival to the emergency department (ED) has improved outcomes in massive transfusion patients. In massively transfused patients when this 1:1 ratio of plasma to PRBCs was used, mortality was 20%, compared to 65% in equally injured transfused at 1:4 ra tio casualties (p less than 0.001; unpublished data, Spinella and Perkins). In civilian trauma centers uncontrolled hemorrhage is also one of the leading causes of potentially preventable death. Most physicians use the standard Advanced Trauma Life Support (ATLS) guidelines, starting resuscitation with crystalloid, then moving to PRBC and only after liters of these fluids, adding plasma, platelets and more rarely, cryoprecipitate, with transfusion plasma to PRBC ratios varying from 1:1 to 1:10. This standar d practice likely serves to exacerbate the coagulopathy of trauma, present on admission in the most critically injured patients. We anticipate that the study will be conducted in two phases. The first phase will be a run-in phase lasting approximately six months. This phase will include all elements of the second phase but will serve to ensure that appropriate implementation of the Transfusion Clinical Practice Guideline, patient enrolment, data collection, sample collection and processing and data integr ity issues are addressed prior to the initiation of the main study phase. Phase II will last approximately 12 months, consist of 300-450 patient enrolments, and include collection of treatment data, outcomes data, site laboratory values, and collection of samples for central laboratory processing. The DCC will be expected to: * Establish infrastructure for reporting of clinical data o Establish a secure web based data submission form and management of Consortium-developed comprehensive dat a collection and data management systems that addresses the needs of all Sites in terms of access to data, data security, and data integrity measures o Conduct ongoing data analysis to monitor site data quality metrics, compliance with inclusion and exc lusion criteria and enrolment rates o Identify missing and erroneous data entries, generate queries to the submitting site and resolve data quality issues o Develop the prospective data collection protocol o Establishment and management of proced ures to ensure that all sites maintain compliance with local Institutional Review Boards (IRBs) and the Army Surgeon Generals Human Subjects Research Review Bo ard (HSRRB) for the conduct of clinical studies and the protection of human subjects o Establish infrastructure for 1. annual meeting consortium members to be conducted conjunction with a national trauma meeting such as ATACCC, AAST, or similar. 2 . support of standing consortium committees (Publication, Laboratory, Data Analysis, Blood bank, Transfusion Clinical Practice Guidelines) * Contract with Consortium members initiate data collection and disburse payments o Conduct initial site survey and assessment o Contract for the required materiel and personnel infrastructure to begin data and sample collection o Conduct site initiation visit to ensure that each site can successfully initiate data and sample collection o Conduct initial a nd ongoing training for study site personnel, maintain records of site study specific training o Conduct periodic site visits to ensure continued compliance with contractual agreements and study quality * Coordinate sample collection and processing< BR>o Establish central laboratory capability to ensure the standardized analyses of specimens through the establishment of a core facility o Coordinate collection, shipping, processing, data collection and reporting of centrally processed laboratory val ues o Coordinate the long term storage of reference clinical samples for future use * Conduct data analysis o Conduct ongoing data analysis for primary and secondary study endpoints, report these ongoing data analyses to government representatives on a quarterly basis o Plan and conduct statistical analysis of data * Post-data collection o Conduct final data analysis and publish reports of primary and secondary study endpoints o Conduct site close out o Provide administrative, edito rial, and statistical support for publication of study results in peer reviewed journals It is the responsibility of the Coordinating Center PI to clearly and explicitly state how the proposed Coordinating Center will provide administrative support, ass istance with protocol development, assistance with the human use regulatory processes, statistical support, data management and storage, as well as the responsibilities described above, for up to 15 Clinical Study Sites. Proposed Study Sites and POC 1. USAISR John B. Holcomb 2. University of Minnesota, Department of Surgery Gregory Bielman 3. University of Washington, Department of Surgery Eileen Bulger 4. U of Tennessee HSC, Department of Surgery Martin Croce 5. Mass G eneral Trauma Division Marc DeMoya 6. Md. School of Medicine Richard Dutton 7. U of NV School of Medicine Deborah Kuhls 8. U of Texas HSC Houston, Department of Surgery - Rosemary Kozar 9. U Hospital Cincinati, OH Joseph Johannigman<BR >10. Denver Medical Center Jeffry Kashuk 11. Wake Forrest University School of Medicine, Trauma Service Wayne Meridith 12. U of Texas Southwestern Medical Center, Division of Burn, Trauma and Critical Care Terence OKeefe 13. Emory Universit y, Dept of Surgery Gary Vercruysse 14. University of Pittsburgh Medical Center, Department of Surgery Mazen Zenati 15. Oregon Health and Science University Martin Schrieber 16. U of Texas HSC San Antonio, Department of Surgery Steven Cohn< BR>17. Medical College of Wisconsin Karen Brasel 18. Stanford University Medical Center Susan Brundage 19. Royal London Hospital, UK Karim Brohi 20. Hartford Hospital Philip Spinella 21. University of California, Los Angeles, School of Medicine Henry Cryer 22. U of Pennsylvania Forrest Fernandez 23. U of Southern California Kenji Inaba 24. Virginia Commonwealth University Rao Ivatury 25. University of Michigan School of Medicine Lena Napolitano 26. University o f San Francisco Jean-Francois Pittet 27. Vanderbilt University 28. Wilford Hall AFMC Donald Jenkins 29. Tulane - Draft Data Collection El ements Date/Time of Injury Date/Time Admitted to ED Minutes from Injury to ED Date/Time to First OR Minutes from ED to OR Mechanism of Injury Age Gender Weight ISS ( Head/Neck, Face, Chest, Abdomen, Extremity, External) GCS Score (Eyes, Verbal, Motor) Intubated in Field Intubated in ED Systolic Blood Pressure Diastolic Blood Pressure Pulse Respiratory Rate Temperature Prothrombin (PT) Partial Prothrombin (PTT) INR Fibrinogen Platelet He moglobin Base Deficit Lactate pH Units PRBC (0-6hr & 6-24hrs & 24hrs) Units FFP (0-6hr & 6-24hrs & 24hrs) Units Platelets (0-6hr & 6-24hrs & 24hrs) Units Cryo (0-6hr & 6-24hrs & 24hrs) Time from admit to first unit FFP Lo cation where first FFP given Liters Normal Saline (0-6hrs & 6-24hrs) Liters Lactated Ringers (0-6hrs & 6-24hrs) Liters Other (0-6hrs & 6-24hrs) Liters Hextend (0-6hrs & 6-24hrs) Liters Hespan (0-6hrs & 6-24hrs) Liters Albumin (0-6hr s & 6-24hrs) Liters Other (0-6hrs & 6-24hrs) Dose(s) FVIIa/#doses in 24hrs/Total amount Procoagulants (type, dose, dose/24hrs) Prehospital Anticoagulant (Warfarin, Plavix, ASA, Other Mortality (Date, Time, less or greater 24hrs) Ventilat or Days ICU Days Hospital Days P/F ratio on admit to ICU O2 Index on admit to ICU P/F ratio at 24hrs O2 Index at 24hrs
- Web Link
-
USAMRAA website
(http://www.usamraa.army.mil)
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Country: US
- Zip Code: 21702-5014
- Record
- SN01467830-W 20071213/071211224247 (fbodaily.com)
- Source
-
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