Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2007-02-13
2016-03-23
Brief Summary
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Detailed Description
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The detailed study protocol was published in in June 2015 and the results were published in September 2022. Both publications are Open Access (See References section for publication details)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Hyperbaric oxygen treatment
Subjects in the HBO treatment group will receive a course of hyperbaric oxygen therapy (HBO) in addition to normal trauma and general care. A total of 12 HBO sessions will be delivered over approximately 8 days. HBO treatment will be provided at 2.4 atmospheres absolute (ATA) pressure for approximately 90 minutes of oxygen therapy. Treatments should be twice daily for the first three days. Minor variability will be allowed with respect to timing and profile of each session.
Hyperbaric Oxygen Treatment
Subjects in the HBO treatment group will receive a course of hyperbaric oxygen therapy (HBO) in addition to normal trauma and general care. A total of 12 HBO sessions will be delivered over approximately 8 days. HBO treatment will be provided at 2.4 atmospheres absolute (ATA) pressure for approximately 90 minutes of oxygen therapy. Treatments should be twice daily for the first three days. Minor variability will be allowed with respect to timing and profile of each session.
No hyperbaric oxygenation
Patients randomised to this group will receive standard trauma care.
No interventions assigned to this group
Interventions
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Hyperbaric Oxygen Treatment
Subjects in the HBO treatment group will receive a course of hyperbaric oxygen therapy (HBO) in addition to normal trauma and general care. A total of 12 HBO sessions will be delivered over approximately 8 days. HBO treatment will be provided at 2.4 atmospheres absolute (ATA) pressure for approximately 90 minutes of oxygen therapy. Treatments should be twice daily for the first three days. Minor variability will be allowed with respect to timing and profile of each session.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Enrolment within 48 hours of injury with expectation of commencement of HBO therapy within 48 hours of injury
* Valid consent
Exclusion Criteria
* Injuries incompatible with HBO
* resuscitation requirements incompatible with HBO
* follow up not possible
* hyperbaric contra indications
18 Years
ALL
No
Sponsors
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Monash University
OTHER
National Health and Medical Research Council, Australia
OTHER
Bayside Health
OTHER_GOV
Responsible Party
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Principal Investigators
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Ian L Millar, MBBS
Role: STUDY_CHAIR
Bayside Health
Owen Williamson
Role: PRINCIPAL_INVESTIGATOR
Monash University
Peter Cameron
Role: PRINCIPAL_INVESTIGATOR
Monash University
Locations
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John Muir Clinical Research Center
Concord, California, United States
Royal Hobart Hospital
Hobart, Tasmania, Australia
The Alfred
Melbourne, Victoria, Australia
Universitatsklinikum Graz
Graz, , Austria
Hospital del Trabajador
Santiago, , Chile
City Hospital of Ostrava
Ostrava, , Czechia
Indraprastha Apollo Hospital
New Delhi, Sarita Vihar, India
Policlinico Umberto 1, University of Rome
Rome, , Italy
Hospital Pedro Hispano
Senhora da Hora, Matosinhos, Portugal
Karolinska Hospital
Stockholm, , Sweden
Countries
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References
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Bouachour G, Cronier P, Gouello JP, Toulemonde JL, Talha A, Alquier P. Hyperbaric oxygen therapy in the management of crush injuries: a randomized double-blind placebo-controlled clinical trial. J Trauma. 1996 Aug;41(2):333-9. doi: 10.1097/00005373-199608000-00023.
Garcia-Covarrubias L, McSwain NE Jr, Van Meter K, Bell RM. Adjuvant hyperbaric oxygen therapy in the management of crush injury and traumatic ischemia: an evidence-based approach. Am Surg. 2005 Feb;71(2):144-51.
Millar IL, McGinnes RA, Williamson O, Lind F, Jansson KA, Hajek M, Smart D, Fernandes T, Miller R, Myles P, Cameron P. Hyperbaric Oxygen in Lower Limb Trauma (HOLLT); protocol for a randomised controlled trial. BMJ Open. 2015 Jun 11;5(6):e008381. doi: 10.1136/bmjopen-2015-008381.
Millar IL, Lind FG, Jansson KA, Hajek M, Smart DR, Fernandes TD, McGinnes RA, Williamson OD, Miller RK, Martin CA, Gabbe BJ, Myles PS, Cameron PA; HOLLT investigator group. Hyperbaric Oxygen for Lower Limb Trauma (HOLLT): an international multi-centre randomised clinical trial. Diving Hyperb Med. 2022 Sep 30;52(3):164-174. doi: 10.28920/dhm52.3.164-174.
Related Links
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HOLLT website
Other Identifiers
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206/04
Identifier Type: -
Identifier Source: org_study_id
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