Acute Stroke Clinical Trial
Official title:
Effects of Repetitive Hyperbaric Oxygen Therapy in Patients With Acute Ischaemic Stroke
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.
Study Methods:
Study Population A 60 adult (aged >18 years) patients were included with a diagnosis of acute
thromboembolic ischemic stroke within 48 hours after onset, according to clinical picture and
imaging findings by brain computed tomography (CT) without evidence of hemorrhage, upon
admission to the hospital and no patient received thrombolytic therapy.
Inclusion criteria:
Group one, HBOT group (n = 30): thirty adult patients with acute ischemic stroke will receive
conventional medical treatment ( as antiplatelet but not thrombolytic therapy) with 10
sessions of adjunctive hyperbaric oxygen therapy (HBOT) within 3-5 days after the onset of
stroke .
Compared with Group two, control group(n = 30): thirty adult patients with acute ischemic
stroke will receive conventional medical treatment alone.
The baseline clinical characteristics were similar in both groups.
Exclusion criteria:
- Patient with cerebral hemorrhage
- Patient received thrombolytic therapy
- Emphysema with carbon dioxide retention
- Pneumothorax
- Seizure disorder
- Uncontrolled high fever
Demographic Characteristics:
Adults more than 18 years, Any gender. All patients upon admission to the hospital will
provide:
Complete history taking:Age, Gender, Smoking, Alcohol consumption, Past history: diabetes
mellitus , hypertension , Chronic obstructive pulmonary disease, Epilepsy or cardiovascular
disease.
Neurological assessment use NIHSS score Blood tests:Complete blood count , Coagulation
profile, Fasting blood sugar., Renal function test (Urea and creatinine).
CT brain
Chest x-ray :
Electrocardiogram (ECG):
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