NCT01454869

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 17, 2012

Status Verified

December 1, 2012

Enrollment Period

4 months

First QC Date

October 17, 2011

Last Update Submit

December 14, 2012

Conditions

Heparin

Keywords

heparin

Outcome Measures

Primary Outcomes (1)

  • Lung Injury Score

    (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

    Daily untill 7 days post injury

Secondary Outcomes (4)

  • Mortality

    28 days post injury

  • pt/ptt

    Up to 7 days post injury

  • Duration of mechanical ventilation

    7 days post injury

  • Duration of hospital stay

    7 days post injury

Study Arms (2)

Standard care

ACTIVE COMPARATOR

nac + salotamul

Drug: standard care

heparin group

EXPERIMENTAL

heparin group

Drug: Heparin

Interventions

standard careDRUG

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.

Also known as: routin
Standard care
HeparinDRUG

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).

Also known as: new
heparin group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Burn patients admitted to Motahary burn center with documented inhalation injury (as defined by clinical or bronchoscopic evaluation)

You may not qualify if:

  • Non-survivable burn patients;
  • history of coagulation disease;
  • chronic obstructive pulmonary disease(COPD);
  • pneumonia diagnosed at admission;
  • inability to confirm definitive diagnosis of inhalation injury and co poisoning or Cyanide hydrogen intoxication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Mothary Burn Hospital

Tehran, Tehran Province, Iran

Location

Related Publications (12)

  • 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: 19517070BACKGROUND

  • 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: 3356738BACKGROUND

  • 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: 17927568BACKGROUND

  • 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: 9622463BACKGROUND

  • 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: 19793551BACKGROUND

  • 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: 20196715BACKGROUND

  • 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: 11298629BACKGROUND

  • 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: 2256764BACKGROUND

  • 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: 3800465BACKGROUND

  • 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: 8577005BACKGROUND

  • 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: 12653676BACKGROUND

  • 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.

    PMID: 180744BACKGROUND

MeSH Terms

Interventions

Standard of CareHeparin

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Seyed H Salehi, MD

    Burn research of Tehran university of Medical Sciences

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2011

First Posted

October 19, 2011

Study Start

February 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2014

Last Updated

December 17, 2012

Record last verified: 2012-12

Locations

IR(1)