Melatonin effect in Stroke patients

Evaluation of melatonin effect on coagulation factors in hemorrhagic stroke

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201610225073N2

Enrollment

Registered

2016-11-27

Start date

2016-11-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hemorrhagic stroke. Intracerebral haemorrhage, unspecified

Interventions

Intervention 1: Patients in the first group will be receiving 30 mg of Melatonin daily via gastric tube. Intervention 2: Patients in the second group will not receive this medicine.

Treatment - Drugs

Patients in the first group will be receiving 30 mg of Melatonin daily via gastric tube

Patients in the second group will not receive this medicine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Platelet count. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Flow cytometry.;Fibrinogen. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Immunoassay.;D-dimer. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Immunoassay.;Melatonin serum level. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Immunoassay.;PT (INR). Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Clotting Test.;PTT. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Clotting Test.;Thrombin Time. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Clotting Test.;Tissue Factor (TF). Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Immunoassay.;Tissue Factor Pathway Inhibitor (TFPI). Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Immunoassay.;Von Willebrand Factor (vWF). Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Immunoassay.;Plasminogen activator inhibitor type 1 (PAI-1). Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Immunoassay.;Factor VIIa. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Immunoassay.;Factor XIIa. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Immunoassay.;Factor XIIIa. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Immunoassay.	—

Measure

Time frame

Platelet count. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Flow cytometry.;Fibrinogen. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Immunoassay.;D-dimer. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Immunoassay.;Melatonin serum level. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Immunoassay.;PT (INR). Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Clotting Test.;PTT. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Clotting Test.;Thrombin Time. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Clotting Test.;Tissue Factor (TF). Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Immunoassay.;Tissue Factor Pathway Inhibitor (TFPI). Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Immunoassay.;Von Willebrand Factor (vWF). Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Immunoassay.;Plasminogen activator inhibitor type 1 (PAI-1). Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Immunoassay.;Factor VIIa. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Immunoassay.;Factor XIIa. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Immunoassay.;Factor XIIIa. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Immunoassay.

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Secondary

Measure	Time frame
Mortality. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: APACHE II.;Organ Failure. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: MODS.;Level of consciousness. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Glasgow Coma Scale (GCS).;NIH Stroke Scale. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Scoring.	—

Measure

Time frame

Mortality. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: APACHE II.;Organ Failure. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: MODS.;Level of consciousness. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Glasgow Coma Scale (GCS).;NIH Stroke Scale. Timepoint: Before and 5 days after melatonin initiation. Method of measurement: Scoring.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMajid Shohrati

Baqiyatallah University of Medical Sciences

shohratimajid@yahoo.com00

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026