Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
Study NCT ID:
NCT04356859
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2020-04-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Acute Burn ResUscitation Multicenter Prospective Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000075462', 'term': 'Serum Albumin, Human'}, {'id': 'D000418', 'term': 'Albumins'}], 'ancestors': [{'id': 'D012709', 'term': 'Serum Albumin'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization will be based on "intent to treat." Consecutively admitted and eligible burn patients will be assigned to one of two treatment groups (Colloid or Crystalloid) within 12 hours of burn injury.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2020-04-20', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volume of fluid received during resuscitation for burn injury', 'timeFrame': '24 hours post burn injury', 'description': 'Total fluid resuscitation volume at 24 hours post burn in mL/kg/% TBSA burn'}], 'secondaryOutcomes': [{'measure': 'Volume of fluid received during resuscitation for burn injury', 'timeFrame': '48 hours post burn injury', 'description': 'Total resuscitation volume at 48 hours in mL/kg/%TBSA burn.'}, {'measure': 'Urine output during resuscitation for burn injury', 'timeFrame': '24 and 48 hours post burn injury', 'description': 'Mean hourly urine output during resuscitation for burn injury'}, {'measure': 'Number of crossovers', 'timeFrame': '48 hours post burn injury', 'description': 'Number of crossovers between study arms during resuscitation for burn injury'}, {'measure': 'Peak lactate and delta lactate', 'timeFrame': '48 hours post burn injury', 'description': 'peak lactate level and delta lactate (peak lactate minus admission lactate)'}, {'measure': 'Peak intra-abdominal pressure (IAP) and delta IAP', 'timeFrame': '48 hours post burn injury', 'description': 'Peak intra-abdominal pressure (IAP) and delta IAP (peak IAP minus admission IAP)'}, {'measure': 'Occurrence of Abdominal compartment syndrome', 'timeFrame': '48 hours post burn injury', 'description': 'Abdominal compartment syndrome during resuscitation for burn injury'}, {'measure': 'Occurrence of Limb or abdominal fasciotomy', 'timeFrame': '48 hours post burn injury', 'description': 'Limb or abdominal fasciotomy during resuscitation for burn injury'}, {'measure': 'Sequential Organ Failure Assessment (SOFA) score', 'timeFrame': '48, 72, and 96 hours post burn injury', 'description': 'Assessment of organ function or failure by Sequential Organ Failure Assessment (SOFA)score, with the higher score(s) indicating organ failure'}, {'measure': 'Acute kidney injury (AKI)', 'timeFrame': '96 hours post burn injury', 'description': 'Diagnosis of AKI'}, {'measure': 'Duration of intubation/mechanical ventilation', 'timeFrame': '96 hours post burn injury', 'description': 'Duration of intubation/mechanical ventilation'}, {'measure': 'PaO2/FiO2 ratios', 'timeFrame': '24, 48, 72, and 96 hours post burn injury', 'description': 'PaO2(partial pressure of oxygen)/FiO2(fraction of inspired oxygen inspired oxygen) ratios'}, {'measure': 'Time to wound healing', 'timeFrame': '7 days post last surgery for grafting of burn injury', 'description': 'Time to wound healing defined as 7 days post last grafting surgery'}, {'measure': 'Survival', 'timeFrame': '28 days post injury and hospital discharge', 'description': '28 day survival and hospital stay survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resuscitation'], 'conditions': ['Burn Injury']}, 'referencesModule': {'references': [{'pmid': '11003341', 'type': 'BACKGROUND', 'citation': 'Pruitt BA Jr. Protection from excessive resuscitation: "pushing the pendulum back". J Trauma. 2000 Sep;49(3):567-8. doi: 10.1097/00005373-200009000-00030. No abstract available.'}, {'pmid': '10501327', 'type': 'BACKGROUND', 'citation': 'Zak AL, Harrington DT, Barillo DJ, Lawlor DF, Shirani KZ, Goodwin CW. Acute respiratory failure that complicates the resuscitation of pediatric patients with scald injuries. J Burn Care Rehabil. 1999 Sep-Oct;20(5):391-9. doi: 10.1097/00004630-199909000-00011.'}, {'pmid': '12478039', 'type': 'BACKGROUND', 'citation': 'Hobson KG, Young KM, Ciraulo A, Palmieri TL, Greenhalgh DG. Release of abdominal compartment syndrome improves survival in patients with burn injury. J Trauma. 2002 Dec;53(6):1129-33; discussion 1133-4. doi: 10.1097/00005373-200212000-00016.'}, {'pmid': '17414612', 'type': 'BACKGROUND', 'citation': 'Klein MB, Hayden D, Elson C, Nathens AB, Gamelli RL, Gibran NS, Herndon DN, Arnoldo B, Silver G, Schoenfeld D, Tompkins RG. The association between fluid administration and outcome following major burn: a multicenter study. Ann Surg. 2007 Apr;245(4):622-8. doi: 10.1097/01.sla.0000252572.50684.49.'}, {'pmid': '1194720', 'type': 'BACKGROUND', 'citation': 'Recinos PR, Hartford CA, Ziffren SE. Fluid resuscitation of burn patients comparing a crystalloid with a colloid containing solution: a prospective study. J Iowa Med Soc. 1975 Oct;65(10):426-32. No abstract available.'}, {'pmid': '6342554', 'type': 'BACKGROUND', 'citation': 'Goodwin CW, Dorethy J, Lam V, Pruitt BA Jr. Randomized trial of efficacy of crystalloid and colloid resuscitation on hemodynamic response and lung water following thermal injury. Ann Surg. 1983 May;197(5):520-31. doi: 10.1097/00000658-198305000-00004.'}, {'pmid': '16398734', 'type': 'BACKGROUND', 'citation': 'Cooper AB, Cohn SM, Zhang HS, Hanna K, Stewart TE, Slutsky AS; ALBUR Investigators. Five percent albumin for adult burn shock resuscitation: lack of effect on daily multiple organ dysfunction score. Transfusion. 2006 Jan;46(1):80-9. doi: 10.1111/j.1537-2995.2005.00667.x.'}, {'pmid': '15920417', 'type': 'BACKGROUND', 'citation': "O'Mara MS, Slater H, Goldfarb IW, Caushaj PF. A prospective, randomized evaluation of intra-abdominal pressures with crystalloid and colloid resuscitation in burn patients. J Trauma. 2005 May;58(5):1011-8. doi: 10.1097/01.ta.0000162732.39083.15."}, {'pmid': '27077832', 'type': 'BACKGROUND', 'citation': 'Muller Dittrich MH, Brunow de Carvalho W, Lopes Lavado E. Evaluation of the "Early" Use of Albumin in Children with Extensive Burns: A Randomized Controlled Trial. Pediatr Crit Care Med. 2016 Jun;17(6):e280-6. doi: 10.1097/PCC.0000000000000728.'}, {'pmid': '23143614', 'type': 'BACKGROUND', 'citation': 'Cartotto R, Callum J. A review of the use of human albumin in burn patients. J Burn Care Res. 2012 Nov-Dec;33(6):702-17. doi: 10.1097/BCR.0b013e31825b1cf6.'}, {'pmid': '4973463', 'type': 'BACKGROUND', 'citation': 'Baxter CR, Shires T. Physiological response to crystalloid resuscitation of severe burns. Ann N Y Acad Sci. 1968 Aug 14;150(3):874-94. doi: 10.1111/j.1749-6632.1968.tb14738.x. No abstract available.'}, {'pmid': '734610', 'type': 'BACKGROUND', 'citation': 'Pruitt BA Jr. Fluid and electrolyte replacement in the burned patient. Surg Clin North Am. 1978 Dec;58(6):1291-1312. doi: 10.1016/s0039-6109(16)41692-0. No abstract available.'}, {'pmid': '376227', 'type': 'BACKGROUND', 'citation': 'Pruitt BA Jr. The burn patient: II. Later care and complications of thermal injury. Curr Probl Surg. 1979 May;16(5):1-95. doi: 10.1016/s0011-3840(79)80009-x.'}, {'pmid': '12142578', 'type': 'BACKGROUND', 'citation': 'Cartotto RC, Innes M, Musgrave MA, Gomez M, Cooper AB. How well does the Parkland formula estimate actual fluid resuscitation volumes? J Burn Care Rehabil. 2002 Jul-Aug;23(4):258-65. doi: 10.1097/00004630-200207000-00006.'}, {'pmid': '20616649', 'type': 'BACKGROUND', 'citation': "Cartotto R, Zhou A. Fluid creep: the pendulum hasn't swung back yet! J Burn Care Res. 2010 Jul-Aug;31(4):551-8. doi: 10.1097/BCR.0b013e3181e4d732."}, {'pmid': '10752739', 'type': 'BACKGROUND', 'citation': 'Engrav LH, Colescott PL, Kemalyan N, Heimbach DM, Gibran NS, Solem LD, Dimick AR, Gamelli RL, Lentz CW. A biopsy of the use of the Baxter formula to resuscitate burns or do we do it like Charlie did it? J Burn Care Rehabil. 2000 Mar-Apr;21(2):91-5. doi: 10.1097/00004630-200021020-00002.'}, {'pmid': '14960986', 'type': 'BACKGROUND', 'citation': 'Cancio LC, Chavez S, Alvarado-Ortega M, Barillo DJ, Walker SC, McManus AT, Goodwin CW. Predicting increased fluid requirements during the resuscitation of thermally injured patients. J Trauma. 2004 Feb;56(2):404-13; discussion 413-4. doi: 10.1097/01.TA.0000075341.43956.E4.'}, {'pmid': '17438489', 'type': 'BACKGROUND', 'citation': 'Saffle JI. The phenomenon of "fluid creep" in acute burn resuscitation. J Burn Care Res. 2007 May-Jun;28(3):382-95. doi: 10.1097/BCR.0B013E318053D3A1.'}, {'pmid': '446052', 'type': 'BACKGROUND', 'citation': 'Jelenko C 3rd, Williams JB, Wheeler ML, Callaway BD, Fackler VK, Albers CA, Barger AA. Studies in shock and resuscitation, I: use of a hypertonic, albumin-containing, fluid demand regimen (HALFD) in resuscitation. Crit Care Med. 1979 Apr;7(4):157-67.'}, {'pmid': '20061836', 'type': 'BACKGROUND', 'citation': 'Lawrence A, Faraklas I, Watkins H, Allen A, Cochran A, Morris S, Saffle J. Colloid administration normalizes resuscitation ratio and ameliorates "fluid creep". J Burn Care Res. 2010 Jan-Feb;31(1):40-7. doi: 10.1097/BCR.0b013e3181cb8c72.'}, {'pmid': '21131844', 'type': 'BACKGROUND', 'citation': 'Faraklas I, Lam U, Cochran A, Stoddard G, Saffle J. Colloid normalizes resuscitation ratio in pediatric burns. J Burn Care Res. 2011 Jan-Feb;32(1):91-7. doi: 10.1097/BCR.0b013e318204b379.'}, {'type': 'BACKGROUND', 'citation': 'Mehrkens HH, Ahnefeld FW. Volume and fluid replacement in the early post burn period: an animal experimental study. Burns 1979;5:113-15'}, {'pmid': '4723430', 'type': 'BACKGROUND', 'citation': 'Asch MJ, Feldman RJ, Walker HL, Foley FD, Popp RL, Mason AD Jr, Pruitt BA Jr. Systemic and pulmonary hemodynamic changes accompanying thermal injury. Ann Surg. 1973 Aug;178(2):218-21. doi: 10.1097/00000658-197308000-00020. No abstract available.'}, {'pmid': '6695330', 'type': 'BACKGROUND', 'citation': 'Demling RH, Kramer G, Harms B. Role of thermal injury-induced hypoproteinemia on fluid flux and protein permeability in burned and nonburned tissue. Surgery. 1984 Feb;95(2):136-44.'}, {'pmid': '6200946', 'type': 'BACKGROUND', 'citation': 'Demling RH, Kramer GC, Gunther R, Nerlich M. Effect of nonprotein colloid on postburn edema formation in soft tissues and lung. Surgery. 1984 May;95(5):593-602.'}, {'pmid': '1999916', 'type': 'BACKGROUND', 'citation': 'Onarheim H, Reed RK. Thermal skin injury: effect of fluid therapy on the transcapillary colloid osmotic gradient. J Surg Res. 1991 Mar;50(3):272-8. doi: 10.1016/0022-4804(91)90190-w.'}, {'pmid': '5924792', 'type': 'BACKGROUND', 'citation': 'Moncrief JA. Effect of various fluid regimens and pharmacologic agents on the circulatory hemodynamics of the immediate postburn period. Ann Surg. 1966 Oct;164(4):723-52. doi: 10.1097/00000658-196610000-00017. No abstract available.'}, {'pmid': '23117385', 'type': 'BACKGROUND', 'citation': 'Park SH, Hemmila MR, Wahl WL. Early albumin use improves mortality in difficult to resuscitate burn patients. J Trauma Acute Care Surg. 2012 Nov;73(5):1294-7. doi: 10.1097/TA.0b013e31827019b1.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective randomized multi-center study which will compare acute fluid resuscitation using a colloid strategy (LR + 5% Albumin) to a crystalloid strategy (LR alone), in adults with an acute burn involving at least 25% of their total body surface area.', 'detailedDescription': 'Enrolled subjects will be randomly assigned to either the Colloid Group or the Crystalloid Group. Randomization will be based on an intent-to-treat basis. In order to ensure that the two groups have comparable injury severity at baseline, randomization will be block- stratified based on age (18-50 and \\> 50 years), burn size (25-50% and \\> 50% TBSA), and presence of inhalation injury confirmed by bronchoscopy (present or absent). In the Colloid Group resuscitation starts with LR and then 5% albumin will be introduced between 8 and 12 hours post burn in a ratio of 1/3 albumin to 2/3 LR. In the Crystalloid Group resuscitation is with LR only. Each group will have their study fluid maintained for the 1st 48 hours post burn and study fluids in each group will be identically titrated to the urinary output.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Total burn size (second and third degree) is ≥ 25% of the TBSA\n* Burn center admission within 12 hours of injury.\n* There is a plan for formal fluid resuscitation.\n\nExclusion Criteria:\n\n* Significant associated trauma\n* High voltage (≥ 1000 volts) electrical burns\n* Burn wound excision surgery within 48 hours from injury\n* Fresh frozen plasma (FFP) given at any time ≤ 48 hours from injury\n* Hypertonic saline (HTS) given at any time ≤ 48 hours from injury\n* Hydroxyethyl starch (HES) given at any time ≤ 48 hours from injury\n* High dose Vitamin C infusion given at any time ≤ 48 hours from injury\n* Administration of human albumin prior to randomization\n* Palliative comfort measures are instituted ≤ 48 hours from injury\n* Pregnancy\n* Pre-injury chronic renal insufficiency equal to or greater than stage 3\n* Pre-injury chronic hepatic disease (Child-Pugh B or C)\n* Pre-injury left ventricular (LV) dysfunction (echocardiography LV grade II-IV or ejection fraction ≤ 35%)'}, 'identificationModule': {'nctId': 'NCT04356859', 'acronym': 'ABRUPT2', 'briefTitle': 'The Acute Burn ResUscitation Multicenter Prospective Trial', 'organization': {'class': 'OTHER', 'fullName': 'American Burn Association'}, 'officialTitle': 'The Acute Burn ResUscitation Multicenter Prospective Trial (ABRUPT2)', 'orgStudyIdInfo': {'id': '1528946'}, 'secondaryIdInfos': [{'id': 'CDMRP-JW180038', 'type': 'OTHER_GRANT', 'domain': 'US Army Department of Defense CDMRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Crystalloid', 'description': "Subjects in the crystalloid group will receive fluid resuscitation with Lactated Ringer's titrated each hour to achieve a urine output of 0.5-1mL/kg predicted body weight."}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Colloid', 'description': "Subjects in the colloid group will receive fluid resuscitation with Lactated Ringer's and 5% human albumin solution introduced no earlier than 8 hours post burn and no later than 12 hours post burn in a ratio by volume of 1/3 albumin to 2/3 Lactated Ringer's, and titrated each hour to achieve a urine output of 0.5-1mL/kg (milliliter/kilogram) predicted body weight.", 'interventionNames': ['Drug: Albumin Human']}], 'interventions': [{'name': 'Albumin Human', 'type': 'DRUG', 'otherNames': ['albumin'], 'description': 'Addition of albumin during acute resuscitation following burn injury', 'armGroupLabels': ['Colloid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85008', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Claudia Islas', 'role': 'CONTACT', 'email': 'claudia.islas@valleywise.health.org'}, {'name': 'Karen Richey', 'role': 'CONTACT', 'email': 'karen.richey2@valleywisehealth.org'}, {'name': 'Kevin Foster, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Arizona Burn Center Valleywise Health', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katrina Falwell, RN, BSN', 'role': 'CONTACT', 'email': 'kafalwell@ucdavis.edu', 'phone': '916-453-2134'}, {'name': 'MaryBeth Lawless, RN, MS', 'role': 'CONTACT', 'email': 'mblawless@ucdavis.edu', 'phone': '916-453-2132'}, {'name': 'David G Greenhalgh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California Davis, Regional Burn Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Naiwei Hsu-Chang', 'role': 'CONTACT', 'email': 'Naiwei.chang@tmmc.com'}, {'name': 'Vimal Murthy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Torrance Memorial', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tera Thigpin', 'role': 'CONTACT', 'email': 'tera.thigpin@surgery.ufl.edu'}, {'name': 'Ian Driscoll, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Florida Health', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ron Manning', 'role': 'CONTACT', 'email': 'rmanning@med.miami.edu'}, {'name': 'Shevonne Satahoo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Miami Health System', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Thanh Tran', 'role': 'CONTACT', 'email': 'thanhtran@health.usf.edu'}, {'name': 'David Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aerial Williams', 'role': 'CONTACT', 'email': 'awilliams23@luc.edu'}, {'name': 'Crystal Wiley-Brown', 'role': 'CONTACT', 'email': 'cwileybrown@luc.edu'}, {'name': 'John Kubasiak, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Loyola Medicine', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Collette Galet', 'role': 'CONTACT', 'email': 'colette-galet@uiowa.edu'}, {'name': 'Lucy Wibbenmeyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Iowa Healthcare', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Reynolds', 'role': 'CONTACT', 'email': 'jreynolds11@kumc.edu'}, {'name': 'Dhaval Bhavsar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kansas Health System', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Fischer', 'role': 'CONTACT', 'email': 'sarah.fischer@ascension.org'}, {'name': 'Thomas Resch, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ascension Via Christi St. Francis', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Domenic Annand', 'role': 'CONTACT', 'email': 'dannand@mgh.harvard.edu'}, {'name': 'Jeremy Goverman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emily Colonna', 'role': 'CONTACT', 'email': 'emily.colonna@hcmed.org'}, {'name': 'Frederick Endorf, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hennepin Healthcare', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '07039', 'city': 'Livingston', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Paula Alem', 'role': 'CONTACT', 'email': 'paula.alem@rwjbh.org'}, {'name': 'Michael Marano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cooperman Barnabas Medical Center', 'geoPoint': {'lat': 40.79593, 'lon': -74.31487}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marcy Jordan', 'role': 'CONTACT', 'email': 'marcyjor@buffalo.edu'}, {'name': 'James Lukan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Erie County Medical Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anuritha Tirumani', 'role': 'CONTACT', 'email': 'anuritha.tirumani@wmchealth.org'}, {'name': 'Francis Winski, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Westchester Medical Center Health Network', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': "D'Ann Hershel", 'role': 'CONTACT', 'email': 'dhershel@wakehealth.edu'}, {'name': 'James Holmes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Atrium Health Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carolina Rodriguez', 'role': 'CONTACT', 'email': 'rodrigc@ucmail.uc.edu'}, {'name': 'Dina Gomaa', 'role': 'CONTACT', 'email': 'gomaada@ucmail.uc.edu'}, {'name': 'Elizabeth Dale, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Cincinnati College of Medicine', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cynthia Newman', 'role': 'CONTACT', 'email': 'cnewman@metrohealth.org'}, {'name': 'Jeffrey Claridge, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Metrohealth Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristin Hickey', 'role': 'CONTACT'}, {'name': 'Niknam Eshraghi, MD, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Legacy Health', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shelly Evans', 'role': 'CONTACT', 'email': 'shelly.evans@ahn.org'}, {'name': 'Ariel Aballay, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'West Penn Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yvonne Shaw', 'role': 'CONTACT', 'email': 'dmhill@regionalonehealth.org; yshaw@uthsc.edu'}, {'name': 'Ram Velamuri, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Tennessee Health Science Center', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yan Zhai', 'role': 'CONTACT', 'email': 'yan.zhai@hsc.utah.edu'}, {'name': 'Giavonni Lewis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Utah Health', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98014', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emily Eschelbach', 'role': 'CONTACT', 'email': 'eschee13@uw.edu'}, {'name': 'Tam Pham', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Regional Burn Center at Harborview', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Veronica Wang', 'role': 'CONTACT', 'email': 'wangm@surgery.wisc.edu'}, {'name': 'Angela Gibson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Wisconsin Health', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': 'AB T6G 1Z1', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Sharada Manchikanti', 'role': 'CONTACT', 'email': 'sharada.manchikanti@albertahealthservices.ca'}, {'name': 'Peter Kwan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'M4N3M5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Elizabeth Calvieri', 'role': 'CONTACT', 'email': 'Elizabeth.Calvieri@sunnybrook.ca'}, {'name': 'Robert Cartotto, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Katrina Falwell, RN, BSN', 'role': 'CONTACT', 'email': 'kafalwell@ucdavis.edu', 'phone': '916-453-2134'}, {'name': 'Mary Beth Lawless, RN, MS', 'role': 'CONTACT', 'email': 'mblawless@ucdavis.edu', 'phone': '916-453-2132'}], 'overallOfficials': [{'name': 'David G Greenhalgh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC Davis Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American Burn Association', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}