drugset / Trial / NCT01454869
The Effect of Heparin on Inhalation Injury
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2012-02
- Primary completion
- 2012-06
- Completion
- 2014-06
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Heparin | Other / unclassified | 5000 iu | Other |
Indications
No indication recorded.