Ignite Creation Date:
2024-05-06 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03431402
Status:
UNKNOWN
Last Update Posted:
2018-03-14
First Post:
2018-02-01
Brief Title:
Effects of Repetitive Hyperbaric Oxygen Therapy in Patients With Acute Ischaemic Stroke
Sponsor:
Kasr El Aini Hospital
Organization:
Kasr El Aini Hospital
Study Overview
Official Title:
Effects of Repetitive Hyperbaric Oxygen Therapy in Patients With Acute Ischaemic Stroke
Status:
UNKNOWN
Status Verified Date:
2018-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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 34 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 89 cerebral palsy 10traumatic 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 1air or gas embolism 5 2carbon monoxide poisoning 34 3clostridial myositis and myonecrosis 16 4crush injury compartment syndrome and other acute traumatic ischemias 17 5decompression sickness 18 6arterial insufficiencies 19 7severe anemia 20 8intracranial abscess 21 9necrotizing soft tissue infections 2210 refractory osteomyelitis 23 11delayed radiation injury 24 12compromised grafts and flaps 25 13acute thermal burn injury 26 and 14idiopathic 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 2829 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
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 andor 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 34 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 89 cerebral palsy 10traumatic 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 1air or gas embolism 5 2carbon monoxide poisoning 34 3clostridial myositis and myonecrosis 16 4crush injury compartment syndrome and other acute traumatic ischemias 17 5decompression sickness 18 6arterial insufficiencies 19 7severe anemia 20 8intracranial abscess 21 9necrotizing soft tissue infections 2210 refractory osteomyelitis 23 11delayed radiation injury 24 12compromised grafts and flaps 25 13acute thermal burn injury 26 and 14idiopathic 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 2829 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
Detailed Description:
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 groupn 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 takingAge Gender Smoking Alcohol consumption Past history diabetes mellitus hypertension Chronic obstructive pulmonary disease Epilepsy or cardiovascular disease
Neurological assessment use NIHSS score Blood testsComplete blood count Coagulation profile Fasting blood sugar Renal function test Urea and creatinine
CT brain
Chest x-ray
Electrocardiogram ECG
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 groupn 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 takingAge Gender Smoking Alcohol consumption Past history diabetes mellitus hypertension Chronic obstructive pulmonary disease Epilepsy or cardiovascular disease
Neurological assessment use NIHSS score Blood testsComplete blood count Coagulation profile Fasting blood sugar Renal function test Urea and creatinine
CT brain
Chest x-ray
Electrocardiogram ECG
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None