Progesterone in the Treatment of Acute Hemorrhagic Stroke

NCT04143880 | Unknown Phase 4

• 1 other identifier: YANWQ001
• Study Type: interventional
• Target: 184
• Locations: 0 countries
• Sites: N/A

Brief Summary

A large number of preclinical studies have confirmed that progesterone and its metabolites have strong neuroprotective effects. As a neuroprotective agent, progesterone has been effective in several animal models of nerve injury, suggesting that the drug has a wide range of neuroprotective effects. Pharmacodynamic studies have shown that some characteristic mechanisms of the action of the neurosteroid on brain injury and cerebral congestion include: prevention of inflammatory reaction and cell death (by inhibiting the activation of inflammatory cytokines and microglia); control of angiogenic brain edema (by reestablishing blood-brain barrier and regulating aquaporin-4 water transporter) and cytotoxic edema (by regulating Progesterone can also improve the neural dysfunction after cerebral hemorrhage, promote the regeneration and repair of damaged axons (activate PI3K / Akt pathway to inhibit the expression of RhoA), prevent the loss of Ca2 + caused by excitotoxicity and improve the survival rate of neurons. It was found that progesterone injection could reduce brain edema and promote the recovery of nerve function after brain injury.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale

  The percentage of patients with Mrs score 0, 1 and 2 was compared.

  3 month

Study Arms (2)

experimental group

EXPERIMENTAL

Progesterone

Drug: Progesterone

control grou

PLACEBO COMPARATOR

saline

Other: saline

Interventions

Progesterone DRUG

intramuscular injection intranasal administration

Also known as: progesterone injection

experimental group

saline OTHER

intramuscular injection intranasal administration

control grou

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute hemorrhagic stroke was confirmed by CT or MRI. There should be no obvious sequelae symptoms in the first stroke or previous stroke, Mrs \< 2 (slight or no neurological dysfunction).
• Patients aged 40-80 (male, menopausal women);
• Patients with 6-48 hours of onset;
• points ≤ NIHSS score ≤ 15 points for light and medium patients;
• Patients or family members sign informed consent.

You may not qualify if:

• Cerebral CT has excluded intracranial hemorrhage, and there is no imaging change of early large area cerebral infarction.
• Pregnant or lactating women;
• Previous intracranial hemorrhage, including suspected subarachnoid hemorrhage; large area stroke (\> 2 / 3 MCA territory) or head CT showed any degree of midline displacement due to brain edema. Signs of intracranial hemorrhage (ICH, SAH, extradural hemorrhage, acute or chronic SDH) were found on baseline CT or MRI scan.
• Fever, defined as central body temperature \> 37.5 ℃;
• Patients with severe heart, liver and kidney dysfunction or severe diabetes;
• Platelet count was less than 100 × 109 / L, blood glucose was less than 27 mmol / L, serum creatinine was more than 2.0 mg / dL or 180 μ mol / L.
• Blood pressure: systolic pressure \> 180 mmHg, or diastolic pressure \> 100 mmHg;
• Those who have previous allergic history to progesterone and citicoline;
• The anticoagulant has been taken orally, and INR is more than 15; heparin has been taken within 48 hours (APTT is beyond the normal range);
• Participating in clinical trials of any other treatment;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Korea University Anam Hospital: collaborator
• Seoul National University Hospital: collaborator
• Lishui Country People's Hospital: collaborator
• Jinhua Central Hospital: collaborator
• Huzhou Central Hospital: collaborator
• The Affiliated Hospital of Hangzhou Normal University: collaborator

MeSH Terms

Conditions

Stroke

Interventions

Progesterone; Sodium Chloride

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 29, 2019
• Study Start: February 1, 2020
• Primary Completion: October 31, 2020
• Study Completion: December 31, 2020
• Last Updated: November 27, 2019

Record last verified: 2019-10