The Effect of Heparin on Inhalation Injury

This study has been withdrawn prior to enrollment.
(Due to insufficient funds)
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01454869
First received: October 17, 2011
Last updated: December 14, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Heparin
Drug: standard care
Drug: Heparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Heparin Nebulization on Lung Injury Score in Inhalation Burn Injury

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Lung Injury Score [ Time Frame: Daily untill 7 days post injury ] [ Designated as safety issue: Yes ]
    (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


Secondary Outcome Measures:
  • Mortality [ Time Frame: 28 days post injury ] [ Designated as safety issue: Yes ]
    Physical exam & EKG

  • pt/ptt [ Time Frame: Up to 7 days post injury ] [ Designated as safety issue: Yes ]
    Daily

  • Duration of mechanical ventilation [ Time Frame: 7 days post injury ] [ Designated as safety issue: Yes ]
  • Duration of hospital stay [ Time Frame: 7 days post injury ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: February 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard care
nac + salotamul
Drug: standard care
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.
Other Name: routin
Experimental: heparin group
heparin group
Drug: Heparin
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).
Other Name: new

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454869

Locations
Iran, Islamic Republic of
Shahid Mothary Burn Hospital
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Study Chair: Seyed H Salehi, MD Burn research of Tehran university of Medical Sciences
  More Information

Additional Information:
Publications:

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01454869     History of Changes
Other Study ID Numbers: 89-04-129-12415
Study First Received: October 17, 2011
Last Updated: December 14, 2012
Health Authority: Iran: Ethics Committee

Keywords provided by Tehran University of Medical Sciences:
heparin

Additional relevant MeSH terms:
Wounds and Injuries
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 20, 2014