The Role of Melatonin in the Regulation of Blood Coagulation (COME)
The main aim is to examine the influence of daylight and melatonin on the temporal variations of hemostatic factors with key roles in the hemostatic process and its regulation. Particular emphasis will be on exploring the role of melatonin in hemostasis by comparing subjects with tetraplegia with able-bodied control subjects.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||The Role of Melatonin in the Regulation of Blood Coagulation|
- Circadian variation of hemostatic factors [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Sleep only
Placebo given at night to tetraplegic individuals before going to sleep,
Active Comparator: Melatonin
Melatonin given at night to tetraplegic individuals before going to sleep.
|Drug: Melatonin ("Circadin")|