Protocol summary

Summary
The aim of the study is to evaluate melatonin effect on coagulation following hemorrhagic stroke. This survey is a randomized clinical trial on 30 patients in intensive care unit (Sina hospital). Patients who are eligible to be included in the trial, admission to ICU within 72 hours of hemorrhagic stroke, will be randomly enrolled in two groups after a written consent is obtained. Patients in the first group will be receiving 30 mg of Melatonin daily via gastric tube while patients in the second group will not receive this medicine. Patients in each group will receive the standard treatment for hemorrhagic stroke. Each patient will be monitored for 5 days and 2 blood samples will be taken, first before melatonin administration and then 5 days later. Blood samples will be centrifuged and the serum will be kept in -80 C for later assessments. Markers which will be evaluated include D-dimer, fibrinogen, platelet count, PT, PTT, TT, serum melatonin level, Tissue Factor (TF), Tissue Factor Pathway Inhibitor (TFPI), Von Willebrand Factor (vWF), Plasminogen Activator Inhibitor type 1 (PAI-1) and Factors VIIa, XIIa and XIIIa. Parameters of neurologic improvement will be monitored on daily basis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201610225073N2
Registration date: 2016-11-27, 1395/09/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-11-27, 1395/09/07
Registrant information
Name
Majid Shohrati
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
shohrati@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences (TUMS)
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of melatonin effect on coagulation factors in hemorrhagic stroke
Public title
Melatonin effect in Stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who are admitted to ICU within 72 hours of hemorrhagic stroke Exclusion criteria: hepatic failure; brain tumor; Melatonin hypersensitivity; Rhomatologic or autoimmune diseases
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Baqiyatallah University of Medical Sciences
Street address
Molasadra street
City
Tehran
Postal code
Approval date
2016-10-16, 1395/07/25
Ethics committee reference number
IR.BMSU.REC.1395.89

Health conditions studied

1

Description of health condition studied
hemorrhagic stroke
ICD-10 code
I.61.9
ICD-10 code description
Intracerebral haemorrhage, unspecified

Primary outcomes

1

Description
Platelet count
Timepoint
Before and 5 days after melatonin initiation
Method of measurement
Flow cytometry

2

Description
Fibrinogen
Timepoint
Before and 5 days after melatonin initiation
Method of measurement
Immunoassay

3

Description
D-dimer
Timepoint
Before and 5 days after melatonin initiation
Method of measurement
Immunoassay

4

Description
Melatonin serum level
Timepoint
Before and 5 days after melatonin initiation
Method of measurement
Immunoassay

5

Description
PT (INR)
Timepoint
Before and 5 days after melatonin initiation
Method of measurement
Clotting Test

6

Description
PTT
Timepoint
Before and 5 days after melatonin initiation
Method of measurement
Clotting Test

7

Description
Thrombin Time
Timepoint
Before and 5 days after melatonin initiation
Method of measurement
Clotting Test

8

Description
Tissue Factor (TF)
Timepoint
Before and 5 days after melatonin initiation
Method of measurement
Immunoassay

9

Description
Tissue Factor Pathway Inhibitor (TFPI)
Timepoint
Before and 5 days after melatonin initiation
Method of measurement
Immunoassay

10

Description
Von Willebrand Factor (vWF)
Timepoint
Before and 5 days after melatonin initiation
Method of measurement
Immunoassay

11

Description
Plasminogen activator inhibitor type 1 (PAI-1)
Timepoint
Before and 5 days after melatonin initiation
Method of measurement
Immunoassay

12

Description
Factor VIIa
Timepoint
Before and 5 days after melatonin initiation
Method of measurement
Immunoassay

13

Description
Factor XIIa
Timepoint
Before and 5 days after melatonin initiation
Method of measurement
Immunoassay

14

Description
Factor XIIIa
Timepoint
Before and 5 days after melatonin initiation
Method of measurement
Immunoassay

Secondary outcomes

1

Description
Mortality
Timepoint
Before and 5 days after melatonin initiation
Method of measurement
APACHE II

2

Description
Organ Failure
Timepoint
Before and 5 days after melatonin initiation
Method of measurement
MODS

3

Description
Level of consciousness
Timepoint
Before and 5 days after melatonin initiation
Method of measurement
Glasgow Coma Scale (GCS)

4

Description
NIH Stroke Scale
Timepoint
Before and 5 days after melatonin initiation
Method of measurement
Scoring

Intervention groups

1

Description
Patients in the first group will be receiving 30 mg of Melatonin daily via gastric tube
Category
Treatment - Drugs

2

Description
Patients in the second group will not receive this medicine
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Majid Shohrati
Street address
Imam street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Saidi
Street address
Keshavarz Blv
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Majid Shohrati
Position
Critical care fellowship
Other areas of specialty/work
Street address
Molasadra street
City
Tehran
Postal code
Phone
00
Fax
Email
shohratimajid@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Majid Shohrati
Position
Associate Professor
Other areas of specialty/work
Street address
Molasadra Street
City
Tehran
Postal code
Phone
00
Fax
Email
shohratimajid@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Majid Shohrati
Position
Associate Professor
Other areas of specialty/work
Street address
Molasadra street
City
Tehran
Postal code
Phone
00
Fax
Email
shohratimajid@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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