NCT03431402

Effects of Repetitive Hyperbaric Oxygen Therapy in Patients With Acute Ischaemic Stroke

Status unknown NA Last updated 14 March 2018

What this trial tests

NA trial testing Hyperbaric oxygen in Acute Stroke in 60 participants. Status unknown.

Timeline

1 March 2018

Primary endpoint
1 March 2020

1 June 2020

Quick facts

Lead sponsor	Kasr El Aini Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	60
Start date	1 March 2018
Primary completion	1 March 2020
Estimated completion	1 June 2020
Sites	1 location across Egypt

Drugs / interventions tested

• Hyperbaric oxygen — full drug profile →

Conditions studied

• Acute Stroke — all drugs for Acute Stroke →

Sponsor

Kasr El Aini Hospital

Who can join

Adults 18 to 80, any sex, with Acute Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background and Rationale:

Cerebrovascular disease is always ranked at the top causes of death and most of hospitalized acute stroke patients have ischemic stroke \[1\].

Although the mortality rate of acute ischemic stroke is less than that of hemorrhagic stroke \[1\], it still results in patient disabilities and complications that often lead to significant costs to individuals, families, and society.

Traditional treatment for acute ischemic stroke includes thrombolytic therapy by injecting tissue plasminogen activator (t-PA) within three hours after onset of symptoms \[2\], antiplatelets and/or anticoagulant agents administered within the first 48 hours. Clinically, the narrow time window of thrombolytic therapy and coexisting contraindications limit the use of t-PA \[2\]. Thus, searching for an effective supplemental treatment for acute ischemic stroke is imperative.

Hyperbaric oxygen therapy (HBOT) is valuable in treating acute carbon monoxide poisoning \[3,4\], air or gas embolism \[5\], facilitating wound healing \[6\] and has been used as an adjuvant treatment for many neurological disorders that need further study as concussion \[7\] , stroke \[8,9\], cerebral palsy \[ 10\],traumatic brain injury \[ 11\], cerebral air embolism \[12\], Autism \[13\] and multiple sclerosis \[14\].

Indications of hyperbaric oxygen therapy recommended by undersea and hyperbaric medical society (UHMS) \[15\] are 1.air or gas embolism \[5\], 2.carbon monoxide poisoning \[3,4\], 3.clostridial myositis and myonecrosis \[16\], 4.crush injury, compartment syndrome and other acute traumatic ischemias \[17\], 5.decompression sickness \[18\], 6.arterial insufficiencies \[19\], 7.severe anemia \[20\], 8.intracranial abscess \[21\], 9.necrotizing soft tissue infections \[22\],10. refractory osteomyelitis \[23\], 11.delayed radiation injury \[24\], 12.compromised grafts and flaps \[25\], 13.acute thermal burn injury \[26\] and 14.idiopathic sudden sensorineural hearing loss \[27\].

Known mechanisms of HBOT-induced neuroprotection include enhancing neuronal viability via increased tissue oxygen delivery to the area of diminished blood flow, reducing brain edema, and improving metabolism after ischemia \[28,29\]. Furthermore, a recent study performed on a rat suggested that upregulation of the expression of glial derived neurotrophic factor (GDNF) and nerve growth factor (NGF) might underlie the effect of HBOT \[30\].

The effectiveness of use of Hyperbaric oxygen therapy in human ischemic stroke is still controversial that need further evaluation.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cellular and Molecular Targets for Non-Invasive, Non-Pharmacological Therapeutic/Rehabilitative Interventions in Acute Ischemic Stroke.
   Onose G, Anghelescu A, Blendea D, Ciobanu V, et al · · 2022 · cited 57× · PMID 35055089 · DOI 10.3390/ijms23020907
2. Detrimental Roles of Hypoxia-Inducible Factor-1α in Severe Hypoxic Brain Diseases.
   Choi YK. · · 2024 · cited 23× · PMID 38674050 · DOI 10.3390/ijms25084465