Back to resultsProgesterone in the Treatment of Acute Hemorrhagic Stroke
Primary Purpose
Stroke
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Progesterone
saline
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- 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;
- 3 points ≤ NIHSS score ≤ 15 points for light and medium patients;
- Patients or family members sign informed consent.
Exclusion Criteria:
- 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;
- Patients considered by the researchers not suitable for inclusion.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
experimental group
control grou
Arm Description
Progesterone
saline
Outcomes
Primary Outcome Measures
Modified Rankin Scale
The percentage of patients with Mrs score 0, 1 and 2 was compared.
Secondary Outcome Measures
Full Information
NCT ID
NCT04143880
First Posted
October 15, 2019
Last Updated
November 25, 2019
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Korea University Anam Hospital, Seoul National University Hospital, Lishui Country People's Hospital, Jinhua Central Hospital, Huizhou Municipal Central Hospital, The Affiliated Hospital of Hangzhou Normal University
1. Study Identification
Unique Protocol Identification Number
NCT04143880
Brief Title
Progesterone in the Treatment of Acute Hemorrhagic Stroke
Official Title
An International Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Progesterone Combined Intranasal and Intramuscular Administration in Patients With Acute Hemorrhagic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Anticipated)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Korea University Anam Hospital, Seoul National University Hospital, Lishui Country People's Hospital, Jinhua Central Hospital, Huizhou Municipal Central Hospital, The Affiliated Hospital of Hangzhou Normal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
Detailed Description
The purpose of this clinical trial is to further evaluate the safety and effectiveness of progesterone in the clinical application of major cerebral congestion diseases. The Second Affiliated Hospital of Zhejiang University is the unit in charge of clinical research, and six units participate in the multicenter randomized, double-blind, placebo-controlled clinical trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
184 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
Progesterone
Arm Title
control grou
Arm Type
Placebo Comparator
Arm Description
saline
Intervention Type
Drug
Intervention Name(s)
Progesterone
Other Intervention Name(s)
progesterone injection
Intervention Description
intramuscular injection intranasal administration
Intervention Type
Other
Intervention Name(s)
saline
Intervention Description
intramuscular injection intranasal administration
Primary Outcome Measure Information:
Title
Modified Rankin Scale
Description
The percentage of patients with Mrs score 0, 1 and 2 was compared.
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
3 points ≤ NIHSS score ≤ 15 points for light and medium patients;
Patients or family members sign informed consent.
Exclusion Criteria:
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;
Patients considered by the researchers not suitable for inclusion.
12. IPD Sharing Statement
Learn more about this trial
Progesterone in the Treatment of Acute Hemorrhagic Stroke
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