The Role of Melatonin in the Regulation of Blood Coagulation

Spinal Cord Injured, Tetraplegia Clinical Trial

— COME  

Official title:

The Role of Melatonin in the Regulation of Blood Coagulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741389
• Other study ID #: 2009/295
• Status: Completed
• Phase: Phase 1
• First received: November 30, 2012
• Last updated: October 13, 2017
• Start date: December 2012
• Est. completion date: March 2014

Study information

• Verified date: October 2017
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Intervention group:

• A diagnosis of tetraplegia for at least 2 years, and otherwise healthy.

• Must not use drugs permanently (except anti-spasmolytics).

• Must be able to swallow tablets.

• Must give written consent to participate.

Control group:

• Must be healthy.

• Must not use drugs permanently.

• Must give written consent to participate.

Exclusion Criteria:

Both groups:

• Those with acute or chronic co-morbidity.

• Unable to cooperate.

• Not provided written consent to participate.

Related Conditions & MeSH terms

• Quadriplegia
• Spinal Cord Injured, Tetraplegia

Intervention

Drug:
• Melatonin ("Circadin")

Locations

Country	Name	City	State
Norway	Sunnaas Hospital	Nesodden

Sponsors (3)

Lead Sponsor	Collaborator
University of Oslo	Oslo University Hospital, Sunnaas Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Dahm A, Osterud B, Hjeltnes N, Sandset PM, Iversen PO. Opposite circadian rhythms in melatonin and tissue factor pathway inhibitor type 1: does daylight affect coagulation? J Thromb Haemost. 2006 Aug;4(8):1840-2. — View Citation

Dahm AE, Iversen PO, Hjeltnes N, Sandset PM. Differences in circadian variations of tissue factor pathway inhibitor type 1 between able-bodied and spinal cord injured. Thromb Res. 2006;118(2):281-7. Epub 2005 Aug 31. — View Citation

Kostovski E, Dahm AE, Iversen N, Hjeltnes N, Østerud B, Sandset PM, Iversen PO. Melatonin stimulates release of tissue factor pathway inhibitor from the vascular endothelium. Blood Coagul Fibrinolysis. 2011 Jun;22(4):254-9. doi: 10.1097/MBC.0b013e3283442ce2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circadian variation of hemostatic factors		24 hours