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

NCT03431402 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-03-14

No results posted yet for this study

Summary

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.

Conditions

  • Acute Stroke

Interventions

DRUG

Hyperbaric oxygen

\- HBOT group will receive 10 sessions of HBOT at 2.0 Atmosphere absolute (ATA) for one hour in a hyperbaric chamber pressured with compressed air, whereby patients will breath 100% oxygen to 2 ATA started within 3-5days after the onset of stoke plus conventional therapy as antiplatelets therapy, correction of hypovolaemia , hypoxia and adequate nutrition

Sponsors & Collaborators

  • Kasr El Aini Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2020-03-01
Completion
2020-06-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03431402 on ClinicalTrials.gov