Resuscitation outcomes consortium (roc) data coordinating center

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Project Title: Resuscitation outcomes consortium (roc) data coordinating center
Project Number: 3U01HL077863-09S2
Project web address: Follow on NIH
Organization: University Of Washington, United States, Washington, SEATTLE
Principal Investigators (PI): Van Belle Gerald, US
May Susanne, US
 
Project Description:
The Resuscitation Outcomes Consortium (ROC) will conduct the Prospective, Randomized, Optimal Platelet and Plasma Ratios (PROPPR) Phase III trial to compare 24-hour and 30-day mortality (co-primary outcomes) in 580 subjects receiving differing blood product ratios. Subjects in PROPPR must meet eligibility criteria and be predicted to receive a massive transfusion (MT) within 24 hours of emergency admission to a Level I Adult Trauma Center. The trial begins with a Vanguard Stage (120 subjects) conducted in at least four sites to study two ratios (1:1:2, 1:1:3, plasma:platelets:RBCs) and choose the better arm to carry forward into Phase III to compare to 1:1:1. The closest equivalent to whole blood. 40 subjects per arm, provide 83% probability of correctly choosing the better arm. In the Vanguard Stage, we will assess protocol safety, feasibility and begin study of trauma induced coagulopathy (TIC) and inflammatory markers. In Phase III, 580 total subjects (including 80 from the Vanguard Stage), provide 90% power to detect a difference of 10% or more in 24-hour mortality and 88% power to detect a difference of 12% or more in 30-day mortality, assuming each alpha=0.044, two-sided test, and 11% 24-hour mortality and 23% 30-day mortality in the 1:1:1 group. Mantel-Haenszel tests will be used with site as a stratifying variable. We will describe mechanistic drivers and sequelae of TIC and inflammation, and characterize the natural history of the coagulation milieu with resuscitation after severe injury in randomized patients. Given the life-threatening situation and the prospect of benefit in each treatment arm, exception from informed consent will be used. Susanne May, ROC Data Coordinating Center (DCC), is the Principal Investigator (PI) of contact. Gerald van Belle, DCC, is the PI-PROPPR. John Holcomb is PI of the UTHealth Clinical Coordinating Center, a ROC satellite, supervises the Clinical Sites, as well as the laboratory and systems biology components. Barbara Tilley of The UTHealth School of Public Health is the PI of the Data Coordinating Center, a ROC satellite, manages the data, oversees data quality, provides analyses of blinded and unblinded data, provides on-site study monitors, and reports on safety and interim analyses to the Data Safety Monitoring Committee. RELEVANCE: The knowledge gained from this Phase III trial will impact the way in which massively bleeding patients at hospitals are transfused. By making better decisions regarding which patients are most in need of a massive transfusion, and transfusing the right ratio of blood products to mitigate potential traumatic coagulopathies, trauma teams will be afforded an ability to impact populations and lower the amount of otherwise preventable deaths resulting from hemorrhagic shock.
 
Project Terms:
accident and emergency department adherence admission activity adult arm base biological assay biological markers blinded blood coagulation disorders blood platelets blood product blood specimen cessation of life clinical clinical research site clinical trials design coagulation process data data coordinating center data quality design eligibility determination emergency situation enrollment erythrocytes exhibits goals health sciences hemorrhage hemorrhagic shock hospitals hour inflammation inflammatory inflammatory marker informed consent injury interest knowledge laboratories life measures medical schools meetings modeling monitor mortality natural history outcome patients phase phase iii clinical trials phenotype plasma population primary outcome principal investigator probability process prospective protocols documentation public health schools randomized randomized trial reconstitution reporting resuscitation safety sampling serious adverse event shock side site staging systems biology testing texas time time interval transfusion trauma trauma centers universities washington whole blood
Project Title: Resuscitation outcomes consortium (roc) data coordinating center
Project Number: 3U01HL077863-09S2
Project web address: Follow on NIH
Organization: University Of Washington, United States, Washington, SEATTLE
Principal Investigators (PI): Van Belle Gerald, US
May Susanne, US
 
Project Categories:
Natural Sciences
 
Other Information:
Fiscal Year: 2004
Project Start Date: 1 September 2004
Project End Date: 31 December 2015
Project program: Research Project--Cooperative Agreements
 
Project Funding Information:
Funding Mechanism: Non-SBIR/STTR RPGs
Year Funding Organization Total Funding, $
2013 NIH - National Heart, Lung, And Blood Institute $14,602,000
Project Title: Resuscitation outcomes consortium (roc) data coordinating center
Project Number: 3U01HL077863-09S2
Project web address: Follow on NIH
Organization: University Of Washington, United States, Washington, SEATTLE
Principal Investigators (PI): Van Belle Gerald, US
May Susanne, US
 
Title FY Funding
There are no results for this project in database.
Project Title: Resuscitation outcomes consortium (roc) data coordinating center
Project Number: 3U01HL077863-09S2
Project web address: Follow on NIH
Organization: University Of Washington, United States, Washington, SEATTLE
Principal Investigators (PI): Van Belle Gerald, US
May Susanne, US
 
Project Title Organization FY Funding
Resuscitation Outcomes Consortium (Roc) Data Coordinating CenterUniversity Of Washington2015$1,450,000
Resuscitation Outcomes Consortium (Roc) Data Coordinating CenterUniversity Of Washington2015$6,498,045
Resuscitation Outcomes Consortium (Roc) Data Coordinating CenterUniversity Of Washington2014$1,450,000
Resuscitation Outcomes Consortium (Roc) Data Coordinating CenterUniversity Of Washington2014$6,110,096
Resuscitation Outcomes Consortium (Roc) Data Coordinating CenterUniversity Of Washington2013$5,853,848
Resuscitation Outcomes Consortium (Roc) Data Coordinating CenterUniversity Of Washington2013$1,450,000
Resuscitation Outcomes Consortium (Roc) Data Coordinating CenterUniversity Of Washington2013$14,602,000
Resuscitation Outcomes Consortium (Roc) Data Coordinating CenterUniversity Of Washington2012$1,450,000
Resuscitation Outcomes Consortium (Roc) Data Coordinating CenterUniversity Of Washington2012$6,169,555
Resuscitation Outcomes Consortium (Roc) Data Coordinating CenterUniversity Of Washington2011$1,450,000
Resuscitation Outcomes Consortium (Roc) Data Coordinating CenterUniversity Of Washington2011$6,248,512
Resuscitation Outcomes Consortium (Roc) Data Coordinating CenterUniversity Of Washington2010$4,547,319
Resuscitation Outcomes Consortium (Roc) Data Coordinating CenterUniversity Of Washington2010$1,450,000
Resuscitation Outcomes Consortium (Roc) Data Coordinating CenterUniversity Of Washington2010$36,866,000
Ems Network Data Coordinating CenterUniversity Of Washington2008$5,257,415
Project Title: Resuscitation outcomes consortium (roc) data coordinating center
Project Number: 3U01HL077863-09S2
Project web address: Follow on NIH
Organization: University Of Washington, United States, Washington, SEATTLE
Principal Investigators (PI): Van Belle Gerald, US
May Susanne, US
 
Project number Project title Principal investigator
There are no any related projects.
Project Title: Resuscitation outcomes consortium (roc) data coordinating center
Project Number: 3U01HL077863-09S2
Project web address: Follow on NIH
Organization: University Of Washington, United States, Washington, SEATTLE
Principal Investigators (PI): Van Belle Gerald, US
May Susanne, US
 
Title Journal Year Country Rel
A Geospatial Analysis of Severe Firearm Injuries Compared to Other Injury Mechanisms: Event Characteristics, Location, Timing, and Outcomes. Acad Emerg Med 2016 united states
Design and implementation of the Resuscitation Outcomes Consortium Pragmatic Airway Resuscitation Trial (PART). Resuscitation 2016 ireland
Assessing protocol adherence in a clinical trial with ordered treatment regimens: Quantifying the pragmatic, randomized optimal platelet and plasma ratios (PROPPR) trial experience. Injury 2016 netherlands
Prothrombotic skeletal muscle myosin directly enhances prothrombin activation by binding factors Xa and Va. Blood 2016 united states
Regional incidence and outcome of out-of-hospital cardiac arrest associated with overdose. Resuscitation 2016 ireland
Sex differences in the prehospital management of out-of-hospital cardiac arrest. Resuscitation 2016 ireland
Damage-control resuscitation and emergency laparotomy: Findings from the PROPPR study. J Trauma Acute Care Surg 2016 united states
Effect of gender on outcome of out of hospital cardiac arrest in the Resuscitation Outcomes Consortium. Resuscitation 2016 ireland
Early prediction of outcome after severe traumatic brain injury: a simple and practical model. BMC Emerg Med 2016 england
Using social media for community consultation and public disclosure in exception from informed consent trials. J Trauma Acute Care Surg 2016 united states
Prehospital traumatic cardiac arrest: Management and outcomes from the resuscitation outcomes consortium epistry-trauma and PROPHET registries. J Trauma Acute Care Surg 2016 united states
Association of advanced airway device with chest compression fraction during out-of-hospital cardiopulmonary arrest. Resuscitation 2016 ireland
Unchanged pediatric out-of-hospital cardiac arrest incidence and survival rates with regional variation in North America. Resuscitation 2016 ireland
Association of early withdrawal of life-sustaining therapy for perceived neurological prognosis with mortality after cardiac arrest. Resuscitation 2016 ireland
Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest. N Engl J Med 2016 united states
Overcoming Spatial and Temporal Barriers to Public Access Defibrillators Via Optimization. J Am Coll Cardiol 2016 united states
Making thawed universal donor plasma available rapidly for massively bleeding trauma patients: experience from the Pragmatic, Randomized Optimal Platelets and Plasma Ratios (PROPPR) trial. Transfusion 2015 united states
Out-of-hospital cardiac arrest survival improving over time: Results from the Resuscitation Outcomes Consortium (ROC). Resuscitation 2015 ireland
A controlled resuscitation strategy is feasible and safe in hypotensive trauma patients: results of a prospective randomized pilot trial. J Trauma Acute Care Surg 2015 united states
What is new in the blood bank for trauma resuscitation. Curr Opin Anaesthesiol 2015 united states
A comparison of prehospital lactate and systolic blood pressure for predicting the need for resuscitative care in trauma transported by ground. J Trauma Acute Care Surg 2015 united states
Mortality and ratio of blood products used in patients with severe trauma--reply. JAMA 2015 united states
What is the use of hypothermia for neuroprotection after out-of-hospital cardiac arrest? Stroke 2015 united states
Collider bias in trauma comparative effectiveness research: the stratification blues for systematic reviews. Injury 2015 netherlands
Classification of cardiopulmonary resuscitation chest compression patterns: manual versus automated approaches. Acad Emerg Med 2015 united states
Association between hospital post-resuscitative performance and clinical outcomes after out-of-hospital cardiac arrest. Resuscitation 2015 ireland
Chest compression rates and survival following out-of-hospital cardiac arrest. Crit Care Med 2015 united states
Understanding traumatic shock: out-of-hospital hypotension with and without other physiologic compromise. J Trauma Acute Care Surg 2015 united states
Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA 2015 united states
Trial of Continuous or Interrupted Chest Compressions during CPR. N Engl J Med 2015 united states
Acute blood loss during burn and soft tissue excisions: An observational study of blood product resuscitation practices and focused review. J Trauma Acute Care Surg 2015 united states
Volume versus outcome: More emergency medical services personnel on-scene and increased survival after out-of-hospital cardiac arrest. Resuscitation 2015 ireland
A quantitative analysis of out-of-hospital pediatric and adolescent resuscitation quality--A report from the ROC epistry-cardiac arrest. Resuscitation 2015 ireland
Inaccuracy of patient care reports for identification of critical resuscitation events during out-of-hospital cardiac arrest. Am J Emerg Med 2015 united states
Revisiting the Golden Hour: An Evaluation of Out-of-Hospital Time in Shock and Traumatic Brain Injury. Ann Emerg Med 2015 united states
Detailed description of all deaths in both the shock and traumatic brain injury hypertonic saline trials of the Resuscitation Outcomes Consortium. Ann Surg 2015 united states
International variation in policies and practices related to informed consent in acute cardiovascular research: Results from a 44 country survey. Resuscitation 2015 ireland
A randomized trial of continuous versus interrupted chest compressions in out-of-hospital cardiac arrest: rationale for and design of the Resuscitation Outcomes Consortium Continuous Chest Compressions Trial. Am Heart J 2015 united states
Time on the scene and interventions are associated with improved survival in pediatric out-of-hospital cardiac arrest. Resuscitation 2015 ireland
Does location matter? A proposed methodology to evaluate neighbourhood effects on cardiac arrest survival and bystander CPR. CJEM 2015 england
A Comparison of Invasive Airway Management and Rates of Pneumonia in Prehospital and Hospital Settings. Prehosp Emerg Care 2015 england
Post-discharge outcomes after resuscitation from out-of-hospital cardiac arrest: A ROC PRIMED substudy. Resuscitation 2015 ireland
Resuscitation characteristics and outcomes in suspected drug overdose-related out-of-hospital cardiac arrest. Resuscitation 2014 ireland
Addressing the challenges of obtaining functional outcomes in traumatic brain injury research: missing data patterns, timing of follow-up, and three prognostic models. J Neurotrauma 2014 united states
Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial: design, rationale and implementation. Injury 2014 netherlands
Apples to apples or apples to oranges? International variation in reporting of process and outcome of care for out-of-hospital cardiac arrest. Resuscitation 2014 ireland
Resuscitation Outcomes Consortium-Amiodarone, Lidocaine or Placebo Study (ROC-ALPS): Rationale and methodology behind an out-of-hospital cardiac arrest antiarrhythmic drug trial. Am Heart J 2014 united states
Increased trauma center volume is associated with improved survival after severe injury: results of a Resuscitation Outcomes Consortium study. Ann Surg 2014 united states
Association between survival and early versus later rhythm analysis in out-of-hospital cardiac arrest: do agency-level factors influence outcomes? Ann Emerg Med 2014 united states
Early coronary angiography and induced hypothermia are associated with survival and functional recovery after out-of-hospital cardiac arrest. Resuscitation 2014 ireland
Association of out-of-hospital advanced airway management with outcomes after traumatic brain injury and hemorrhagic shock in the ROC hypertonic saline trial. Emerg Med J 2014 england
The impact of peri-shock pause on survival from out-of-hospital shockable cardiac arrest during the Resuscitation Outcomes Consortium PRIMED trial. Resuscitation 2014 ireland
Performance of goodness-of-fit tests for the Cox proportional hazards model with time-varying covariates. Lifetime Data Anal 2014 united states
What is the optimal chest compression depth during out-of-hospital cardiac arrest resuscitation of adult patients? Circulation 2014 united states
Optimal fluid resuscitation in trauma: type, timing, and total. Curr Opin Crit Care 2014 united states
An evaluation of differences in risk factors for individual types of surgical site infections after colon surgery. Surgery 2014 united states
Prehospital hypertonic saline resuscitation attenuates the activation and promotes apoptosis of neutrophils in patients with severe traumatic brain injury. Shock 2013 united states
Identifying locations for public access defibrillators using mathematical optimization. Circulation 2013 united states
Emergency airway management: can we do better? Resuscitation 2013 ireland
Transfusion of red blood cells in patients with a prehospital Glasgow Coma Scale score of 8 or less and no evidence of shock is associated with worse outcomes. J Trauma Acute Care Surg 2013 united states
Modeling the impact of public access defibrillator range on public location cardiac arrest coverage. Resuscitation 2013 ireland
Determining risk for out-of-hospital cardiac arrest by location type in a Canadian urban setting to guide future public access defibrillator placement. Ann Emerg Med 2013 united states