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Study the effect of Granulocyte colony stimulating factor (G-CSF) influence on neurological and cardiac toxicity caused by carbon monoxide in patients with carbon monoxide poisoning

Study the effect of Granulocyte colony stimulating factor (G-CSF) influence on neurological and cardiac toxicity caused by carbon monoxide in patients with carbon monoxide poisoning in two groups drug and placebo

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT201607232083N7
Enrollment
40
Registered
2017-04-28
Start date
2016-11-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carbon monoxide poisoning. Toxic effect of carbon monoxide

Interventions

Intervention 1: Granulocyte colony-stimulating factor (G-CSF) at dose 180 µg / Kg, one-third of the total dose as a loading dose within 20 minutes and the remaining two-thirds dose for continuous infu
Treatment - Drugs
Placebo
Granulocyte colony-stimulating factor (G-CSF) at dose 180 µg / Kg, one-third of the total dose as a loading dose within 20 minutes and the remaining two-thirds dose for continuous infusion at a consta
100 ml of sodium chloride isotonic injection of a third of the total dose as the dose loading within 20 minutes, and two-thirds of the remaining dose for continuous infusion at a constant rate over 72

Sponsors

Management and technology assistance of Mashhad university of medical sciences, school of pharmac
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: diagnosis of carbon monoxide poisoning based on clinical and laboratory findings; poisoning severity of moderate to severe based on the concentration of carboxyhemoglobin and clinical symptoms (NIHSS); poisoned patients must be enrolled within 24 hours of incidence of toxicity; Age between 18 and 70 years Exclusion criteria: Pregnancy; Other Simultaneous poisoning; Burn; the history of neurosurgical and head trauma During the past 4 weeks; multiple trauma 6 - ischemic stroke or hemorrhagic during the last 4 weeks; Malignancies; chronic inflammatory diseases; hematologic malignancies; allergies and or elevated titers of antibodies against erythropoietin and high blood pressure180/110; cardiovascular disease; any previous cerebrovascular lesions

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
S100B serum concentration. Timepoint: Day 1 pre-intervention, 3 and 30 after intervention. Method of measurement: Elysa kit.;NIHSS. Timepoint: Day 1 pre-intervention, 3 and 30 after intervention. Method of measurement: NIHSS scor chart.;Barthel Index. Timepoint: Day 30 after intervention. Method of measurement: Barthel Index chart.;TI serum concentration. Timepoint: In 3,12, 24, 48 and 72 houers after intervention. Method of measurement: Elysa kit.;Cardiac arrhythmias. Timepoint: During 24 h after intervention. Method of measurement: ECG holter monitor.

Secondary

MeasureTime frame
G-CSF serum concentration. Timepoint: in times 0.5, 1, 2, 5, 8, 12, 24, 48 h after intervention. Method of measurement: elysa kit.;Vital signs: BP, HR, T and RR. Timepoint: Every 4 hours during the first 24 hours, every 6 hours during the second and third days. Method of measurement: By nurse.;Modified Rankin score. Timepoint: In day 30 after intervention. Method of measurement: Modified Rankin score chart.;Carboxyhemoglobin serum concentration. Timepoint: In Day1 (pre-intervention), 3 and 30 after intervention. Method of measurement: GC-mas-mas Headspace.;Glial Fibrilary Acidic protein(GFAP) serum concentration. Timepoint: Day1 (pre-intervention), 3 and 30 after intervention. Method of measurement: Elysa kit.;Myeloperoxidase serum concentration. Timepoint: Day1 (pre-intervention), 3 and 30 after intervention. Method of measurement: Elysa kit.;Myelin basic protein. Timepoint: Day1 (pre-intervention), 3 and 30 after intervention. Method of measurement: Elysa kit.;Cerebral ischemia. Timepoint: Day1 (pre-intervention), 3 and 30 after intervention. Method of measurement: Brain MRI.;Headache, asthenia, memory impairment, sleep disorders, trouble concentrating, visual disturbances and behavioral disorders. Timepoint: Day1 (pre-intervention), 3 and 30 after intervention. Method of measurement: By specialist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Seyed Reza Mousavi

Mashhad University of Medical Sciences

MousaviR@mums.ac.ir+98 518598973

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 24, 2026