Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-01-02 @ 3:46 AM
Study NCT ID:
NCT01454869
Status:
WITHDRAWN
Last Update Posted:
2012-12-17
First Post:
2011-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Heparin on Inhalation Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Due to insufficient funds', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-14', 'studyFirstSubmitDate': '2011-10-17', 'studyFirstSubmitQcDate': '2011-10-18', 'lastUpdatePostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung Injury Score', 'timeFrame': 'Daily untill 7 days post injury', 'description': '(1) chest X-ray evaluated for alveolar consolidation (2) ratio of the partial pressure of oxygen in arterial blood to the inspiratory fraction of oxygen (3) PEEP level if ventilated (4) respiratory compliance'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '28 days post injury', 'description': 'Physical exam \\& EKG'}, {'measure': 'pt/ptt', 'timeFrame': 'Up to 7 days post injury', 'description': 'Daily'}, {'measure': 'Duration of mechanical ventilation', 'timeFrame': '7 days post injury'}, {'measure': 'Duration of hospital stay', 'timeFrame': '7 days post injury'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['heparin'], 'conditions': ['Heparin']}, 'referencesModule': {'references': [{'pmid': '19517070', 'type': 'BACKGROUND', 'citation': 'Maybauer MO, Rehberg S, Traber DL, Herndon DN, Maybauer DM. [Pathophysiology of acute lung injury in severe burn and smoke inhalation injury]. Anaesthesist. 2009 Aug;58(8):805-12. doi: 10.1007/s00101-009-1560-x. German.'}, {'pmid': '3356738', 'type': 'BACKGROUND', 'citation': 'Brown M, Desai M, Traber LD, Herndon DN, Traber DL. Dimethylsulfoxide with heparin in the treatment of smoke inhalation injury. J Burn Care Rehabil. 1988 Jan-Feb;9(1):22-5. doi: 10.1097/00004630-198801000-00007.'}, {'pmid': '17927568', 'type': 'BACKGROUND', 'citation': 'Enkhbaatar P, Esechie A, Wang J, Cox RA, Nakano Y, Hamahata A, Lange M, Traber LD, Prough DS, Herndon DN, Traber DL. Combined anticoagulants ameliorate acute lung injury in sheep after burn and smoke inhalation. Clin Sci (Lond). 2008 Feb;114(4):321-9. doi: 10.1042/CS20070254.'}, {'pmid': '9622463', 'type': 'BACKGROUND', 'citation': 'Desai MH, Mlcak R, Richardson J, Nichols R, Herndon DN. Reduction in mortality in pediatric patients with inhalation injury with aerosolized heparin/N-acetylcystine [correction of acetylcystine] therapy. J Burn Care Rehabil. 1998 May-Jun;19(3):210-2. doi: 10.1097/00004630-199805000-00004.'}, {'pmid': '19793551', 'type': 'BACKGROUND', 'citation': 'Cancio LC. Airway management and smoke inhalation injury in the burn patient. Clin Plast Surg. 2009 Oct;36(4):555-67. doi: 10.1016/j.cps.2009.05.013.'}, {'pmid': '20196715', 'type': 'BACKGROUND', 'citation': 'Toon MH, Maybauer MO, Greenwood JE, Maybauer DM, Fraser JF. Management of acute smoke inhalation injury. Crit Care Resusc. 2010 Mar;12(1):53-61.'}, {'pmid': '11298629', 'type': 'BACKGROUND', 'citation': 'Muller MJ, Pegg SP, Rule MR. Determinants of death following burn injury. Br J Surg. 2001 Apr;88(4):583-7. doi: 10.1046/j.1365-2168.2001.01726.x.'}, {'pmid': '2256764', 'type': 'BACKGROUND', 'citation': 'Tredget EE, Shankowsky HA, Taerum TV, Moysa GL, Alton JD. The role of inhalation injury in burn trauma. A Canadian experience. Ann Surg. 1990 Dec;212(6):720-7. doi: 10.1097/00000658-199012000-00011.'}, {'pmid': '3800465', 'type': 'BACKGROUND', 'citation': 'Shirani KZ, Pruitt BA Jr, Mason AD Jr. The influence of inhalation injury and pneumonia on burn mortality. Ann Surg. 1987 Jan;205(1):82-7. doi: 10.1097/00000658-198701000-00015.'}, {'pmid': '8577005', 'type': 'BACKGROUND', 'citation': 'Darling GE, Keresteci MA, Ibanez D, Pugash RA, Peters WJ, Neligan PC. Pulmonary complications in inhalation injuries with associated cutaneous burn. J Trauma. 1996 Jan;40(1):83-9. doi: 10.1097/00005373-199601000-00016.'}, {'pmid': '12653676', 'type': 'BACKGROUND', 'citation': 'Murakami K, Enkhbaatar P, Shimoda K, Mizutani A, Cox RA, Schmalstieg FC, Jodoin JM, Hawkins HK, Traber LD, Traber DL. High-dose heparin fails to improve acute lung injury following smoke inhalation in sheep. Clin Sci (Lond). 2003 Apr;104(4):349-56.'}, {'pmid': '180744', 'type': 'BACKGROUND', 'citation': 'Janne O, Kontula K, Vihko R. Review article: mechanism of action of female sex steroids. Acta Obstet Gynecol Scand Suppl. 1976;51:29-45. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "This is a prospective randomized clinical trial about the efficacy of heparin nebulization on lung injury score in inhalation burn injury in Mothary burn hospital. This study would consist of 170 burn patients with documented inhalation injury in 2 arms (control group and study group). Allocation ratio is1:1. Masking was not possible. The patients' primary outcome will be assessed for Lung Injury Scale and the patients' secondary outcome will be assessed for mortality, Coagulation tests (PT, PTT), ICU and hospital stay and duration of mechanical ventilation support. Duration of this study is about 32 months.", 'detailedDescription': "This study would consist of 170 burn patients with documented smoke inhalation injury who will be randomized to receive either standard care alone (control group) or standard care plus heparin nebulization in combination with intravenously administrated fresh frozen plasma (study group). Standard care treatment consist of: chest physiotherapy ,early ambulation, airway suctioning, bronchial hygiene therapy , salbutamol nebulization (100-200 µgQ4h)/N-acetyl cysteine 20% nebulization (3cc Q4h) and if needed mechanical ventilation support. Study care treatment consist of: Standard care + Heparin nebulized administration(5000U every 4 hours for 7 days) and fresh frozen plasma intravenously administration (10 cc/Kg daily for 7 days) The patients' primary outcome will be assessed for Lung Injury Scale (LIS) every day by using fallowing parameters: (1) chest X-ray evaluated for alveolar consolidation (2) ratio of the partial pressure of oxygen in arterial blood to the inspiratory fraction of oxygen (3) PEEP level if ventilated (4) respiratory compliance if known Parameter Finding Value Rx.Torax no alveolar consolidation 0 alveolar consolidation de 1 quadrant 1 alveolar consolidation de 2 quadrant 2 alveolar consolidation de 3 quadrant 3 alveolar consolidation de 4 quadrant 4 Hypoxemia PaO2/FIO2 \\> 300 0 PaO2/FIO2 225 - 299 1 PaO2/FIO2 175 - 224 2 PaO2/FIO2 100 - 174 3 PaO2/FIO2 \\< 100 4 PEEP PEEP \\<= 5 cm H2O 0 PEEP 6 - 8 cm H2O 1 PEEP 9 - 11 cm H2O 2 PEEP 12 - 14 cm H2O 3 PEEP \\>= 15 cm H2O 4 Compliance \\>= 80 mL/cm H2O 0 compliance 60 - 79 mL/cm H2O 1 compliance 40 - 59 mL/cm H2O 2 compliance 20 - 39 mL/cm H2O 3 compliance \\<= 19 mL/cm H2O 4 2 The patients' secondary outcome will be assessed for mortality(for 28 days post injury), Coagulation tests(PT,PTT) (for 7 days post injury),ICU and hospital stay(for 7 days post injury) and duration of mechanical ventilation support(for 7 days post injury). In each group 85 Patients will be selected by simple randomization. Allocation ratio is1:1. Blinding of this study was not possible.\n\nPEEP: positive end expiratory pressure- PaO2: partial pressure of oxygen in arterial blood- FIO2: inspiratory fraction of oxygen PT: prothrombin time- PTT: partial thrombin time- ICU: intensive care unite- Rx: X-Ray"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Burn patients admitted to Motahary burn center with documented inhalation injury (as defined by clinical or bronchoscopic evaluation)\n\nExclusion Criteria:\n\n* Non-survivable burn patients;\n* history of coagulation disease;\n* chronic obstructive pulmonary disease(COPD);\n* pneumonia diagnosed at admission;\n* inability to confirm definitive diagnosis of inhalation injury and co poisoning or Cyanide hydrogen intoxication'}, 'identificationModule': {'nctId': 'NCT01454869', 'briefTitle': 'The Effect of Heparin on Inhalation Injury', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'Efficacy of Heparin Nebulization on Lung Injury Score in Inhalation Burn Injury', 'orgStudyIdInfo': {'id': '89-04-129-12415'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care', 'description': 'nac + salotamul', 'interventionNames': ['Drug: standard care']}, {'type': 'EXPERIMENTAL', 'label': 'heparin group', 'description': 'heparin group', 'interventionNames': ['Drug: Heparin']}], 'interventions': [{'name': 'standard care', 'type': 'DRUG', 'otherNames': ['routin'], 'description': 'Standard care treatment consist of chest physiotherapy ,early ambulation, airway suctioning, bronchial hygiene therapy , salbutamol nebulization(100-200 µgQ4h)/N-acetyl cysteine20% nebulization(3cc Q4h) and if needed mechanical ventilation support.', 'armGroupLabels': ['Standard care']}, {'name': 'Heparin', 'type': 'DRUG', 'otherNames': ['new'], 'description': 'Study group would consist of 85 burn patients with documented smoke inhalation injury who will be randomized to receive standard care plus heparin nebulization(5000U every 4 hours for 7 days) in combination with intravenously administrated fresh frozen plasma(10 cc/Kg daily for 7 days).', 'armGroupLabels': ['heparin group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Shahid Mothary Burn Hospital', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Seyed H Salehi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Burn research of Tehran university of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}