Subarachnoid Hemorrhage, AneurysmalPhase 2/3MATSH-SHapENCT04613960
Magnesium Treating Subarachnoid Hemorrhage Vasospasm
A Phase 2/3 study testing Magnesium sulfate and normal saline in people with Subarachnoid Hemorrhage, Aneurysmal and Cerebral Vasospasm, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.
Trial summary
A randomized clinical trial investigating magnesium sulphate ability to reduce risk of cerebral vasospasm after acute subarachnoid hemorrhage hence improving outcome particularly in haptoglobin 2-2 patients who are highly susceptible for severe complications after subarachnoid hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal, Cerebral Vasospasm
- What is being tested?
- Magnesium sulfate and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2022to Jun 2024
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of both genders
- age over 18 years old
- diagnosis of acute aSAH (≤ 48 hours) confirmed with angiographic evidence of cerebral aneurysm and CT brain on admission.
Who cannot join
- subarachnoid hemorrhage due to non-aneurysmal causes
- cerebral stroke of any type during past month
- decompensated heart failure, renal failure or hepatic failure
- difficult bilateral transtemporal transcranial Doppler (TCD) insonation of intracranial arteries due to thick temporal bone of the skull.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnesium in Treating Subarachnoid Hemorrhage Related Vasospasm, A Haptoglobin Genomic Based Randomized Controlled Trial
A randomized clinical trial investigating magnesium sulphate ability to reduce risk of cerebral vasospasm after acute subarachnoid hemorrhage hence improving outcome particularly in haptoglobin 2-2 patients who are highly susceptible for severe complications after subarachnoid hemorrhage.
Read the detailed description
Study Design and Location:
Investigators propose a double blinded, randomized (1:1), placebo-controlled, multicenter, clinical trial including patients with acute aSAH. Participants will be allocated either to MgSO4 or placebo. The permission to conduct the study protocol will be considered for approval by the ethics committee of General Committee of Teaching Hospitals and Institutes (GCTHI), Egypt. The study will be conducted in 3 centers; El-Materia Educational Hospital, Ain Shams University Hospitals and Nasr City Insurance Hospital. The assigned centers for this study represent large-volume referral stroke centers that provide comprehensive management protocols for aSAH.
- Being tested
- Magnesium sulfate, normal saline
- Keywords
- subarachnoid hemorrhage, Haptoglobin, Vasospasm
- Medical subject headings
- Subarachnoid Hemorrhage, Vasospasm, Intracranial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDrug
MgSO4 (at a fixed daily dose of 64 mmol reconstituted in 0.9% saline) via continuous intravenous infusion for 14 days after onset
normal salineDrug
Placebo treatment
| Study group | Role | What they receive |
|---|---|---|
| Magnesium arm | Active comparator | patients randomized to magnesium therapy at a fixed daily dose of 64 mmol reconstituted in 0.9% saline via continuous intravenous infusion for 14 days after hemorrhage onset, or until discharge or death if it occurred. Receives: Drug: Magnesium sulfate |
| Placebo arm | Placebo comparator | patients randomized to placebo therapy with 0.9% saline (without active component) via same protocol. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evidence and TCD measured MFV indicative of vasospasm
Mean flow velocity measurements by TCD indicative of cerebral vasospasm. New clinical neurological deficit determined by comparing NIHSS pre and post detected vasospasm.
Measured: 14 days after onset
Secondary outcomes (1)
Poor MRS functional score
Poor MRS score (4,5 or dead) assessed at regular follow up visits
Measured: 3 months after the onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study startDec 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies of the same condition, open and under way.
- 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
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt
- Sponsor type
- Other government
- Collaborators
- Ain Shams University, Health Insurance Organization, Egypt
- Responsible party
- Principal investigator, Ahmed Mohammed Ateia, General Committee of Teaching Hospitals and Institutes, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613960
- Sponsor's protocol ID
- MTH/NEUR/20/01
- Acronym
- MATSH-SHapE
- Status last verified
- Sep 2022
- First submitted
- 28 Oct 2020
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Reddy D, Fallah A, Petropoulos JA, Farrokhyar F, Macdonald RL, Jichici D. Prophylactic magnesium sulfate for aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis. Neurocrit Care. 2014 Oct;21(2):356-64. doi: 10.1007/s12028-014-9964-0.
PubMed 24619389Soliman R, Zohry G. [Effect of magnesium sulphate and milrinone on cerebral vasospasm after aneurysmal subarachnoid hemorrhage: a randomized study]. Braz J Anesthesiol. 2019 Jan-Feb;69(1):64-71. doi: 10.1016/j.bjan.2018.09.005. Epub 2018 Nov 6.
PubMed 30409409Thomsen JH, Etzerodt A, Svendsen P, Moestrup SK. The haptoglobin-CD163-heme oxygenase-1 pathway for hemoglobin scavenging. Oxid Med Cell Longev. 2013;2013:523652. doi: 10.1155/2013/523652. Epub 2013 May 27.
PubMed 23781295Milman U, Blum S, Shapira C, Aronson D, Miller-Lotan R, Anbinder Y, Alshiek J, Bennett L, Kostenko M, Landau M, Keidar S, Levy Y, Khemlin A, Radan A, Levy AP. Vitamin E supplementation reduces cardiovascular events in a subgroup of middle-aged individuals with both type 2 diabetes mellitus and the haptoglobin 2-2 genotype: a prospective double-blinded clinical trial. Arterioscler Thromb Vasc Biol. 2008 Feb;28(2):341-7. doi: 10.1161/ATVBAHA.107.153965. Epub 2007 Nov 21.
PubMed 18032779Ateia AM, Elbassiouny A, El-Nabi SH, Fahmy NA, Ibrahim MH, El-Garawani I, Geba KM, Khalaf M. Predictive value of haptoglobin genotype as a risk of cerebral vasospasm after aneurysmal subarachnoid hemorrhage. Clin Neurol Neurosurg. 2020 Dec;199:106296. doi: 10.1016/j.clineuro.2020.106296. Epub 2020 Oct 7.
PubMed 33069930
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium in Treating Subarachnoid Hemorrhage Related Vasospasm, A Haptoglobin Genomic Based Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04613960
- Acronym / sponsor ID
- MATSH-SHapE / MTH/NEUR/20/01
- Keywords
- subarachnoid hemorrhage, Haptoglobin, Vasospasm
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, EgyptOther government
- Collaborators
- Ain Shams University, Health Insurance Organization, Egypt
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 3 Nov 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.
A randomized clinical trial investigating magnesium sulphate ability to reduce risk of cerebral vasospasm after acute subarachnoid hemorrhage hence improving outcome particularly in haptoglobin 2-2 patients who are highly susceptible for severe complications after subarachnoid hemorrhage.
Detailed description
Study Design and Location:
Investigators propose a double blinded, randomized (1:1), placebo-controlled, multicenter, clinical trial including patients with acute aSAH. Participants will be allocated either to MgSO4 or placebo. The permission to conduct the study protocol will be considered for approval by the ethics committee of General Committee of Teaching Hospitals and Institutes (GCTHI), Egypt. The study will be conducted in 3 centers; El-Materia Educational Hospital, Ain Shams University Hospitals and Nasr City Insurance Hospital. The assigned centers for this study represent large-volume referral stroke centers that provide comprehensive management protocols for aSAH.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium arm | Active comparator | Drug: Magnesium sulfatepatients randomized to magnesium therapy at a fixed daily dose of 64 mmol reconstituted in 0.9% saline via continuous intravenous infusion for 14 days after hemorrhage onset, or until discharge or death if it occurred. |
| Placebo arm | Placebo comparator | Drug: normal salinepatients randomized to placebo therapy with 0.9% saline (without active component) via same protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of both genders
- age over 18 years old
- diagnosis of acute aSAH (≤ 48 hours) confirmed with angiographic evidence of cerebral aneurysm and CT brain on admission.
Key exclusion criteria (4 listed)
- subarachnoid hemorrhage due to non-aneurysmal causes
- cerebral stroke of any type during past month
- decompensated heart failure, renal failure or hepatic failure
- difficult bilateral transtemporal transcranial Doppler (TCD) insonation of intracranial arteries due to thick temporal bone of the skull.
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 |
|---|---|---|
| Magnesium sulfateMgSO4 (at a fixed daily dose of 64 mmol reconstituted in 0.9% saline) via continuous intravenous infusion for 14 days after onset | Drug | Magnesium arm |
| normal salinePlacebo treatment | Drug | Placebo arm |
Primary outcome
Clinical evidence and TCD measured MFV indicative of vasospasm
Time frame: 14 days after onset
Mean flow velocity measurements by TCD indicative of cerebral vasospasm. New clinical neurological deficit determined by comparing NIHSS pre and post detected vasospasm.
1 secondary outcome
Poor MRS functional score
Time frame: 3 months after the onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Background: PubMed 24619389Reddy D, Fallah A, Petropoulos JA, Farrokhyar F, Macdonald RL, Jichici D. Prophylactic magnesium sulfate for aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis. Neurocrit Care. 2014 Oct;21(2):356-64. doi: 10.1007/s12028-014-9964-0.
- Background: PubMed 30409409Soliman R, Zohry G. [Effect of magnesium sulphate and milrinone on cerebral vasospasm after aneurysmal subarachnoid hemorrhage: a randomized study]. Braz J Anesthesiol. 2019 Jan-Feb;69(1):64-71. doi: 10.1016/j.bjan.2018.09.005. Epub 2018 Nov 6.
- Background: PubMed 23781295Thomsen JH, Etzerodt A, Svendsen P, Moestrup SK. The haptoglobin-CD163-heme oxygenase-1 pathway for hemoglobin scavenging. Oxid Med Cell Longev. 2013;2013:523652. doi: 10.1155/2013/523652. Epub 2013 May 27.
- Background: PubMed 18032779Milman U, Blum S, Shapira C, Aronson D, Miller-Lotan R, Anbinder Y, Alshiek J, Bennett L, Kostenko M, Landau M, Keidar S, Levy Y, Khemlin A, Radan A, Levy AP. Vitamin E supplementation reduces cardiovascular events in a subgroup of middle-aged individuals with both type 2 diabetes mellitus and the haptoglobin 2-2 genotype: a prospective double-blinded clinical trial. Arterioscler Thromb Vasc Biol. 2008 Feb;28(2):341-7. doi: 10.1161/ATVBAHA.107.153965. Epub 2007 Nov 21.
- Results publication: PubMed 33069930Ateia AM, Elbassiouny A, El-Nabi SH, Fahmy NA, Ibrahim MH, El-Garawani I, Geba KM, Khalaf M. Predictive value of haptoglobin genotype as a risk of cerebral vasospasm after aneurysmal subarachnoid hemorrhage. Clin Neurol Neurosurg. 2020 Dec;199:106296. doi: 10.1016/j.clineuro.2020.106296. Epub 2020 Oct 7.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Magnesium sulfate and normal saline in people with Subarachnoid Hemorrhage, Aneurysmal and Cerebral Vasospasm, run by General Committee of Teaching Hospitals and Institutes, Egypt 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 3 inclusion and 4 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 13 Sep 2022. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Ahmed M Ateia (+201202474777, a_ateia@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evidence and TCD measured MFV indicative of vasospasm (time frame: 14 days after onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04613960, which also lists 5 linked publications.
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 13 Sep 2022.