Skip to main content

Table 2 Visit and assessment schedule

From: The efficacy of dexamethasone on reduction in the reoperation rate of chronic subdural hematoma – the DRESH study: straightforward study protocol for a randomized controlled trial

VISITS

Screening

Post-procedure

Day 2 post operation

Day 3 of drug protocol

Until hospital discharge

Week 4 (16±7 days)

Week 12 (48±7 days)

Week 241(96±7 days)

Informed consent

x

       

Medical history/demographics

x

       

Procedure related information

x

       

Randomization

x

       

Concomitant medications2

x

x

x

x

x

x

  

Physical examination

x

   

x

   

Hematology, biochemistry, coagulation3

x

   

x(OD)4

   

Urine pregnancy test

x

       

Markwalder score

x

   

x (OD)

x

x

x

Blood glucose

   

x

    

Intraocular pressure

    

x

   

Neurological worsening events

    

x

x

x

 

CT scan

x5

 

x6

  

x

x

x

Post-discharge information

     

x

x7

x

Adverse events

  

x

x

x8

   

Serious adverse events

x9

x9

x

x

x

x

x10

 
  1. OD=once a day.
  2. CT=computer tomography.
  3. 1Only in case of reoperation.
  4. 2Concomitant medications will be recorded in the CRF from 2 weeks prior to study drug start and up to the end of study drug medication.
  5. 3Blood will be analyzed locally and the results will be recorded in the CRF.
  6. 4Preoperative oral anticoagulated patients need a coagulation monitoring once a day to keep the parameters normal. In the same way are patients monitored with hyponatremia.
  7. 5If the baseline CT scan performed at a referral center, is of acceptable quality, and is available at the investigational site at the time of screening, it does not need to be repeated. However, if the only baseline CT scan available is a hardcopy film, then it must be repeated at the investigational site.
  8. 6CT scan to be performed during 48h post operation. In case of neurological worsening CT scans are repeated as required.
  9. 7At week 12 the patient will return to the hospital for documentation of his/her residence (e.g. home, rehabilitation centre etc.), any new hospitalizations or surgical procedures (directly or indirectly related to the cSDH) since the first hospital discharge, and to ensure that ongoing AEs/SAEs or new SAEs are followed up/documented. In case of reoperation the same procedure is performed at week 24.
  10. 8AEs reporting and follow-up: Reporting of all new AEs up to one day after study drug discontinuation; follow-up of ongoing AEs only thereafter.
  11. 9SAEs related to study-mandated procedures after signature of informed consent and before study drug administration.
  12. 10Serious adverse events still ongoing at the Study Completion visit must be followed until resolution or stabilization or until the event is otherwise explained. New SAEs occurring at any time after the 21-day follow-up period after study drug discontinuation may be reported to the Sponsor within 24 hours of the investigator´s knowledge of the event, if felt appropriate by the investigators.
Back to article page

Trials

ISSN: 1745-6215