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HeparinPhase 3NCT01454869

The Effect of Heparin on Inhalation Injury

A Phase 3 study testing Heparin in people with Heparin, run by Tehran University of Medical Sciences at 1 site in Iran.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Heparin
What is being tested?
Heparin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteIran
Study dates
Feb 2012to Jun 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Iran1 site

  • Shahid Mothary Burn Hospital

    Tehran, Tehran Province

Other trials in Iran

About this study

Official title: Efficacy of Heparin Nebulization on Lung Injury Score in Inhalation Burn Injury

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.

Read the detailed description

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.

PEEP: 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

Conditions
Heparin
Being tested
standard care, Heparin
Keywords
heparin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • standard careDrug

    Also called routin

    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.

  • HeparinDrug

    Also called new

    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).

Study groups in NCT01454869
Study groupRoleWhat they receive
Standard careActive comparatornac + salotamul
Receives: Drug: standard care
heparin groupExperimentalheparin group
Receives: Drug: Heparin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Daily untill 7 days post injury

Secondary outcomes (4)

  1. Mortality

    Physical exam \& EKG

    Measured: 28 days post injury

  2. pt/ptt

    Daily

    Measured: Up to 7 days post injury

  3. Duration of mechanical ventilation

    Measured: 7 days post injury

  4. Duration of hospital stay

    Measured: 7 days post injury

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2011 (estimated)
  2. Study startFeb 2012
  3. Primary completionJun 2012 (estimated)
  4. Study completionJun 2014 (estimated)

Why it stopped: Due to insufficient funds

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01454869
Sponsor's protocol ID
89-04-129-12415
Status last verified
Dec 2012
First submitted
17 Oct 2011
Last updated
17 Dec 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19517070

  • 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.

    PubMed 3356738

  • 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.

    PubMed 17927568

  • 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.

    PubMed 9622463

  • 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.

    PubMed 19793551

  • 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.

    PubMed 20196715

  • 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.

    PubMed 11298629

  • 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.

    PubMed 2256764

  • 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.

    PubMed 3800465

  • 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.

    PubMed 8577005

  • 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.

    PubMed 12653676

  • 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.

    PubMed 180744

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Heparin in people with Heparin, run by Tehran University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lung Injury Score (time frame: Daily untill 7 days post injury). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01454869, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2012.

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