International Trial of Efficacy of Cytoflavin in Head Trauma
- Conditions
- Head Trauma,Closed
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Age from 18-60 (inclusive).<br><br> 2. Clinical diagnosis of TBI, cerebral contusion of moderate severity without<br> compression.<br><br> 3. The written consent of the legal representative or the decision of the council to<br> include the patient in the study.<br><br> 4. Possibility of a full assessment of eye opening, speech and motor response by GCS.<br><br> 5. GCS at the time of inclusion 9 - 14 (inclusive).<br><br> 6. Time of initiation of study drug therapy within 24 hours after the estimated or<br> determined time of injury.<br><br> 7. The presence of post-traumatic amnesia, confusion and disorientation.<br><br> 8. Absence of indications for neurosurgery or other surgical intervention under general<br> anesthesia.<br><br> 9. Normal brain CT scan, or the presence of subarachnoid hemorrhage and / or contusion<br> foci of I-III types according to Kornienko and / or limited or diffuse cerebral<br> edema.<br><br> 10. The expected duration of hospital stay >= 10 days.<br><br> 11. Absence of a disabling neurological or mental illness, information about the<br> patient's disability prior to injury.<br><br> 12. Possibility to perform all procedures stipulated by the study protocol<br><br>Exclusion Criteria:<br><br> 1. The need to use the therapy prohibited by the study protocol.<br><br> 2. Concomitant injury, except for cases of damage to the skeleton, soft tissues,<br> internal organs, which do not require (1) surgical intervention under general<br> anesthesia, and (2) are not an independent indication for hospital treatment.<br><br> 3. Past / planned surgical intervention for the current episode of trauma under general<br> anesthesia.<br><br> 4. Penetrating open TBI.<br><br> 5. Presence of the following lesions on the results of computed tomography (CT) of the<br> brain performed prior to the patient's randomization:<br><br> 1. epidural hematoma or subdural hematoma;<br><br> 2. evidence of a previous head injury based on CT results;<br><br> 3. type IV contusion foci according to Kornienko's classification.<br><br> 6. Presence of any of the following risk factors for secondary brain injury at any time<br> after TBI: hypoxia (SpO2 <90% based on pulse oximetry results); hypotension<br> (systolic blood pressure <90 mm Hg) or shock;hypothermia (body temperature <35 ° C);<br> clinical signs of respiratory failure, the need for mechanical ventilation.<br><br> 7. Drug addiction.<br><br> 8. Alcohol in saliva >=2 ‰ or a previous diagnosis of alcohol dependence.<br><br> 9. Depression of consciousness, presumably resulting from other reasons (for example,<br> alcohol, drugs, drugs, poisonous substances).<br><br> 10. The presence of aphasia due to focal brain damage, which prevents communication with<br> the researcher.<br><br> 11. Status epilepticus at the time of admission to the hospital or condition after an<br> epileptic seizure.<br><br> 12. Pregnant and lactating women.<br><br> 13. Availability of information about concomitant chronic disease in the stage of<br> decompensation.<br><br> 14. Intolerance to the components of CYTOFLAVIN®, anamnestic data on drug allergy to<br> succinic acid, riboflavin, inosine, or nicotinamide.<br><br> 15. Severe renal or heart failure requiring restriction of the volume of injected fluid.<br><br> 16. The presence of a condition or disease that, in the opinion of the investigator,<br> jeopardizes the patient's safety if the patient participates in the study, or may<br> interfere with the performance of examination procedures, an objective assessment of<br> the patient's condition, or distort the assessment of the outcome of TBI.<br><br> 17. Participation in any clinical study less than 3 months before the start of the<br> study.<br><br> 18. Patients who are employees of the research center and their families.<br><br> 19. Language barrier.<br><br> 20. Availability of information that the patient is a stateless person or a citizen of<br> another state
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Galveston Orientation and Amnesia scale;Glasgow Outcome scale - Extended (GOS-E)
- Secondary Outcome Measures
Name Time Method Glasgow Coma Scale;Barthel Index