Traumatic Brain InjuryEarly Phase 1NCT04426487
Effect of Progesterone Therapy on Traumatic Subarachinoid Haemorrhage on Clinical Outcome and Resistive Vasculer Indices of Middle Cerebral Artery Transcranial Doppler
A Early Phase 1 study testing Progesterone in people with Traumatic Brain Injury, run by Minia University at 1 site in Egypt.
Trial summary
Traumatic subarachinoid hemorrhage is associated with serious complications related to mortality . Delayed neuronal ischemia and rebleeding are most common and serious. Progesterone can delay both . Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Progesterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2020to 30 Oct 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic subarachinoid hemorrhage
Who cannot join
- History of malignency
- History of cerebrovasculer stroke
- Morbid obese
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
ElMinia University
Minya, Abohelal, 6115
Hany Mikhail, 01223448665, hanykm@yahoo.com
About this study
Official title: Effect of Progesterone Therapy in Cases With Traumatic Subarachinoid Haemorrhage on Clinical Outcome and Resistive Vasculer Indices of Middle Cerebral Artery Transcranial Doppler
Traumatic subarachinoid hemorrhage is associated with serious complications related to mortality . Delayed neuronal ischemia and rebleeding are most common and serious. Progesterone can delay both .
Read the detailed description
Progesterone is an neurosteroid that can help integrity of blood brain barrier . Traumatic subarachinoid hemorrhage disrupts this blood brain barrier facilitating post traumatic vasospasm and neuronal ischemia. Transcranial doppler can detect cerebral vasoconstriction through resistive vasculer indices
- Conditions
- Traumatic Brain Injury
- Being tested
- Progesterone
- Keywords
- Progesterone, Transcranial doppler
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
Intramusculer progesterone
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Receiving conventional management for traumatic subarachinoid hemorrhage Receives: Drug: Progesterone |
| progesterone group | Active comparator | Intramusculer progesterone therapy before and after craniotomy Receives: Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants suffering neuronal infarction
Transcranial doppler
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start20 Jun 2020 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Maher, Ministry of Health and Population, Egypt
- Investigators
- Hany Mikhail, MD, Study director, Faculty of medicine. ElMinia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426487
- Sponsor's protocol ID
- 625/4-2020
- Status last verified
- Jun 2020
- First submitted
- 8 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Progesterone Therapy in Cases With Traumatic Subarachinoid Haemorrhage on Clinical Outcome and Resistive Vasculer Indices of Middle Cerebral Artery Transcranial Doppler
- ClinicalTrials.gov ID
- NCT04426487
- Acronym / sponsor ID
- 625/4-2020
- Conditions
- Traumatic Brain Injury
- Keywords
- Progesterone, Transcranial doppler
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 20 Jun 2020 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Traumatic subarachinoid hemorrhage is associated with serious complications related to mortality . Delayed neuronal ischemia and rebleeding are most common and serious. Progesterone can delay both .
Detailed description
Progesterone is an neurosteroid that can help integrity of blood brain barrier . Traumatic subarachinoid hemorrhage disrupts this blood brain barrier facilitating post traumatic vasospasm and neuronal ischemia. Transcranial doppler can detect cerebral vasoconstriction through resistive vasculer indices
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: ProgesteroneReceiving conventional management for traumatic subarachinoid hemorrhage |
| progesterone group | Active comparator | Drug: ProgesteroneIntramusculer progesterone therapy before and after craniotomy |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Traumatic subarachinoid hemorrhage
Key exclusion criteria (3 listed)
- History of malignency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProgesteroneIntramusculer progesterone | Drug | Control, progesterone group |
Primary outcome
Number of participants suffering neuronal infarction
Time frame: 2 months
Transcranial doppler
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hany Mikhail, MD study director
Faculty of medicine. ElMinia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Progesterone in people with Traumatic Brain Injury, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mina Raouf, MD (01015752424, drmina2015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants suffering neuronal infarction (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.