Prophylactic effect of citicoline on the mortality and permanent neurological morbidity of the subacute and chronic subdural hematomas treated with surgery: A double blind randomized placebo controlled clinical trial

Prophylactic effect of citicoline on the mortality and permanent neurological morbidity of the subacute and chronic subdural hematomas treated with surgery in the three and six months follow up : A double blind randomized placebo controlled clinical trial

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000632392

Enrollment

Registered

2008-12-15

Start date

2006-05-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Relatively high mortality and neurological morbidity can be attributed to chronic subdural hematomas even after accepted surgical interventions. Citicoline is a neuroprotective agent known to have positive effects in cerebrovascular surgeries and suggested to be beneficial in different cognitive disorders, traumatic brain injury and various surgical interventions. In this study the authors examine the effect of perioperative prescription of citicoline on mortality and morbidity of chronic subdural hematomas. The null hypothesis is perioperative prophylactic administration of citicoline has no significant effect on mortality and different neuerological morbidities of chronic subdural hematomas treated with surgery.

Interventions

Citicoline Intravenous (IV) injection starting with 1 gram of the drug twice a day from three days before routine surgical treatment until the end of the day of operation. In the first three postoperative days the dose given was 500 milligrams twice a day and in the seven following days the patients were treated with 250 milligrams daily of citicoline intravenously. Citicoline (cytidine_5_diphosphocholine) is an essential intermediate material in the biosynthesis of structural cellular membrane

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

7 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients with subacute and chronic subdural hematoma who were conscious and oriented at the time of admission with ages more than 7 years.

Exclusion criteria

Patients who were not conscious and oriented (Glasgow Coma Scale (GCS)<15), were less than 7 years old and whose hematomas were recurrent ones.

Outcome results