Mechanical ThrombectomyNCT05082896
Multicentre ObseRvational Study in Posterior mecHanical thrombEctomy: conscioUs Sedation vs General aneSthesia
An observational study of Mechanical Thrombectomy and General Anesthesia, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
Trial summary
The association of conscious sedation vs. general anesthesia in ischemic stroke with posterior circulation occlusions undergoing endovascular therapy, is istill unknown. No prospective or clinical trials have studied this effect on posterior circulation strokes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Thrombectomy, General Anesthesia, Conscious Sedation
- What is being tested?
- Type of anesthesia choice
- Type of treatment
- Surgery or procedure
- How many people
- 453 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 30 Jun 2023
- How long will I take part?
- 18 Months
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients eligible for mechanical thrombectomy due to ischemic stroke and presence of arterial occlusion in intracranial posterior circulation
Who may be able to join
- Subject aged ≥ 18 years
- Evidence of posterior arterial occlussion (basilar artery, intracranial vertebral artery and posterior cerebral artery)
- Patients eligible for mechanical thrombectomy
Who cannot join
- Patient's refusal to participate
- Arterial recanalization prior to endovascular thrombectomy attempt
- Patient unable to present or be available for follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentre ObseRvational Study in Posterior mecHanical thrombEctomy: conscioUs Sedation vs General aneSthesia: MORPHEUS STROKE REGISTRY
The association of conscious sedation vs. general anesthesia in ischemic stroke with posterior circulation occlusions undergoing endovascular therapy, is istill unknown.
No prospective or clinical trials have studied this effect on posterior circulation strokes.
The choice of anesthetic regimen is ussually depending on local stroke-team protocols or neurointerventional preference.
MORPHEUS Stroke Registry is a prospective multicentre observational study that investigates the association between anestheisa and functional outcome in patients with posterior circulation large vessel occlusion treated endovascularly.
- Being tested
- Type of anesthesia choice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of anesthesia choiceProcedure or surgery
Use of conscious sedation vs. general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Conscious Sedation | Not described Receives: Procedure: Type of anesthesia choice | |
| General Anesthesia | Not described Receives: Procedure: Type of anesthesia choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional independence at 3 months
Rate of functional independence (modified Rankin Scale 0-2) at 3 months
Measured: 3 months
Secondary outcomes (9)
First Pass Effect
Rate of complete successful recanalization (mTICI 2c-3) with one single pass of device
Measured: 1 day
Mortality
Rate of mortality at 3 months
Measured: 3 months
Successfull recanalization and complete recanalization according to endovascular technique
Rate of mTICI 3 and mTICI 2b-3 according to endovascular technique (contact aspiration, stentriever or combined)
Measured: 1 day, revascularization grade will be assessed
Number of passes
Number of intracranial thrombectomy passes to achieve final reperfusion
Measured: 1 day, number of device passes will be assessed
NIHSS at 24 hours
Rate of neurological status at 24 hours, dramatical neurological improvement after mechanical thrombectomy
Measured: 24 hours
Type of anesthesic and outcome
Study of the type of anesthesic choice and complications, time of intubation and
Measured: 3 months
Length of stentretriever and recanalization
Rates of FPE and succesful recanalization according to the length of stentretriever used
Measured: 1 day, stentretriever type will be assessed
Arterial hypotension during anesthesic induction and outcome
Study of arterial hypotension during anesthesic induction and outcome
Measured: 3 months
Bridging therapy and neurologial/functional outcomes
To study the association between bridging therapy and reperfussion rates, neurological status and funtional independence at 3 months.
Measured: 1 day, type of previous fibrinolytic use will be assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Jan 2021
- Primary completion30 Mar 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Mechanical ThrombectomyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 453 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082896
- Sponsor's protocol ID
- MORPHEUS STROKE REGISTRY
- Status last verified
- Mar 2024
- First submitted
- 13 Sep 2021
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hu G, Shi Z, Li B, Shao W, Xu B. General anesthesia versus monitored anesthesia care during endovascular therapy for vertebrobasilar stroke. Am J Transl Res. 2021 Mar 15;13(3):1558-1567. eCollection 2021.
PubMed 33841679Wu L, Jadhav AP, Chen J, Sun C, Ji K, Li W, Zhao W, Li C, Wu C, Wu D, Ji X. Local anesthesia vs general anesthesia during endovascular therapy for acute posterior circulation stroke. J Neurol Sci. 2020 Sep 15;416:117045. doi: 10.1016/j.jns.2020.117045. Epub 2020 Jul 16.
PubMed 32717535Jadhav AP, Bouslama M, Aghaebrahim A, Rebello LC, Starr MT, Haussen DC, Ranginani M, Whalin MK, Jovin TG, Nogueira RG. Monitored Anesthesia Care vs Intubation for Vertebrobasilar Stroke Endovascular Therapy. JAMA Neurol. 2017 Jun 1;74(6):704-709. doi: 10.1001/jamaneurol.2017.0192.
PubMed 28395002Campbell BCV, van Zwam WH, Goyal M, Menon BK, Dippel DWJ, Demchuk AM, Bracard S, White P, Davalos A, Majoie CBLM, van der Lugt A, Ford GA, de la Ossa NP, Kelly M, Bourcier R, Donnan GA, Roos YBWEM, Bang OY, Nogueira RG, Devlin TG, van den Berg LA, Clarencon F, Burns P, Carpenter J, Berkhemer OA, Yavagal DR, Pereira VM, Ducrocq X, Dixit A, Quesada H, Epstein J, Davis SM, Jansen O, Rubiera M, Urra X, Micard E, Lingsma HF, Naggara O, Brown S, Guillemin F, Muir KW, van Oostenbrugge RJ, Saver JL, Jovin TG, Hill MD, Mitchell PJ; HERMES collaborators. Effect of general anaesthesia on functional outcome in patients with anterior circulation ischaemic stroke having endovascular thrombectomy versus standard care: a meta-analysis of individual patient data. Lancet Neurol. 2018 Jan;17(1):47-53. doi: 10.1016/S1474-4422(17)30407-6. Epub 2017 Dec 16.
PubMed 29263006Bouslama M, Haussen DC, Aghaebrahim A, Grossberg JA, Walker G, Rangaraju S, Horev A, Frankel MR, Nogueira RG, Jovin TG, Jadhav AP. Predictors of Good Outcome After Endovascular Therapy for Vertebrobasilar Occlusion Stroke. Stroke. 2017 Dec;48(12):3252-3257. doi: 10.1161/STROKEAHA.117.018270. Epub 2017 Oct 31.
PubMed 29089457Terceno M, Silva Y, Bashir S, Vera-Monge VA, Cardona P, Molina C, Chamorro A, de la Ossa NP, Hernandez-Perez M, Werner M, Camps-Renom P, Rodriguez-Campello A, Canovas D, Purroy F, Serena J; Catalan Stroke Code and Reperfusion Consortium (Cat-SCR). Impact of general anesthesia on posterior circulation large vessel occlusions after endovascular thrombectomy. Int J Stroke. 2021 Oct;16(7):792-797. doi: 10.1177/1747493020976247. Epub 2020 Dec 1.
PubMed 33573525Gory B, Mazighi M, Labreuche J, Blanc R, Piotin M, Turjman F, Lapergue B; ETIS (Endovascular Treatment in Ischemic Stroke) Investigators. Predictors for Mortality after Mechanical Thrombectomy of Acute Basilar Artery Occlusion. Cerebrovasc Dis. 2018;45(1-2):61-67. doi: 10.1159/000486690. Epub 2018 Jan 30.
PubMed 29393092Schonenberger S, Henden PL, Simonsen CZ, Uhlmann L, Klose C, Pfaff JAR, Yoo AJ, Sorensen LH, Ringleb PA, Wick W, Kieser M, Mohlenbruch MA, Rasmussen M, Rentzos A, Bosel J. Association of General Anesthesia vs Procedural Sedation With Functional Outcome Among Patients With Acute Ischemic Stroke Undergoing Thrombectomy: A Systematic Review and Meta-analysis. JAMA. 2019 Oct 1;322(13):1283-1293. doi: 10.1001/jama.2019.11455.
PubMed 31573636Cappellari M, Pracucci G, Forlivesi S, Saia V, Nappini S, Nencini P, Inzitari D, Greco L, Sallustio F, Vallone S, Bigliardi G, Zini A, Pitrone A, Grillo F, Musolino R, Bracco S, Tinturini R, Tassi R, Bergui M, Cerrato P, Saletti A, De Vito A, Casetta I, Gasparotti R, Magoni M, Castellan L, Malfatto L, Menozzi R, Scoditti U, Causin F, Baracchini C, Puglielli E, Casalena A, Ruggiero M, Malatesta E, Comelli C, Chianale G, Lauretti DL, Mancuso M, Lafe E, Cavallini A, Cavasin N, Critelli A, Ciceri EFM, Bonetti B, Chiumarulo L, Petruzzelli M, Giorgianni A, Versino M, Ganimede MP, Tinelli A, Auteri W, Petrone A, Guidetti G, Nicolini E, Allegretti L, Tassinari T, Filauri P, Sacco S, Pavia M, Invernizzi P, Nuzzi NP, Carmela Spinelli M, Amista P, Russo M, Ferrandi D, Corraine S, Craparo G, Mannino M, Simonetti L, Toni D, Mangiafico S. General Anesthesia Versus Conscious Sedation and Local Anesthesia During Thrombectomy for Acute Ischemic Stroke. Stroke. 2020 Jul;51(7):2036-2044. doi: 10.1161/STROKEAHA.120.028963. Epub 2020 Jun 10.
PubMed 32517584Butt W, Dhillon PS, Podlasek A, Malik L, Nair S, Hewson D, England TJ, Lenthall R, McConachie N. Local anesthesia as a distinct comparator versus conscious sedation and general anesthesia in endovascular stroke treatment: a systematic review and meta-analysis. J Neurointerv Surg. 2022 Mar;14(3):221-226. doi: 10.1136/neurintsurg-2021-017360. Epub 2021 Mar 23.
PubMed 33758063Brinjikji W, Pasternak J, Murad MH, Cloft HJ, Welch TL, Kallmes DF, Rabinstein AA. Anesthesia-Related Outcomes for Endovascular Stroke Revascularization: A Systematic Review and Meta-Analysis. Stroke. 2017 Oct;48(10):2784-2791. doi: 10.1161/STROKEAHA.117.017786. Epub 2017 Sep 13.
PubMed 28904228
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre ObseRvational Study in Posterior mecHanical thrombEctomy: conscioUs Sedation vs General aneSthesia: MORPHEUS STROKE REGISTRY
- ClinicalTrials.gov ID
- NCT05082896
- Acronym / sponsor ID
- MORPHEUS STROKE REGISTRY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 19 Oct 2021 (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.
The association of conscious sedation vs. general anesthesia in ischemic stroke with posterior circulation occlusions undergoing endovascular therapy, is istill unknown.
No prospective or clinical trials have studied this effect on posterior circulation strokes.
The choice of anesthetic regimen is ussually depending on local stroke-team protocols or neurointerventional preference.
MORPHEUS Stroke Registry is a prospective multicentre observational study that investigates the association between anestheisa and functional outcome in patients with posterior circulation large vessel occlusion treated endovascularly.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conscious Sedation | – | Procedure: Type of anesthesia choice |
| General Anesthesia | – | Procedure: Type of anesthesia choice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for mechanical thrombectomy due to ischemic stroke and presence of arterial occlusion in intracranial posterior circulation
Key inclusion criteria (3 listed)
- Subject aged ≥ 18 years
- Evidence of posterior arterial occlussion (basilar artery, intracranial vertebral artery and posterior cerebral artery)
- Patients eligible for mechanical thrombectomy
Key exclusion criteria (3 listed)
- Patient's refusal to participate
- Arterial recanalization prior to endovascular thrombectomy attempt
- Patient unable to present or be available for follow-up
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 |
|---|---|---|
| Type of anesthesia choiceUse of conscious sedation vs. general anesthesia | Procedure or surgery | Conscious Sedation, General Anesthesia |
Primary outcome
Functional independence at 3 months
Time frame: 3 months
Rate of functional independence (modified Rankin Scale 0-2) at 3 months
9 secondary outcomes
First Pass Effect
Time frame: 1 day
Mortality
Time frame: 3 months
Successfull recanalization and complete recanalization according to endovascular technique
Time frame: 1 day, revascularization grade will be assessed
Number of passes
Time frame: 1 day, number of device passes will be assessed
NIHSS at 24 hours
Time frame: 24 hours
Type of anesthesic and outcome
Time frame: 3 months
Length of stentretriever and recanalization
Time frame: 1 day, stentretriever type will be assessed
Arterial hypotension during anesthesic induction and outcome
Time frame: 3 months
Bridging therapy and neurologial/functional outcomes
Time frame: 1 day, type of previous fibrinolytic use will be assessed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Results publication: PubMed 33841679Hu G, Shi Z, Li B, Shao W, Xu B. General anesthesia versus monitored anesthesia care during endovascular therapy for vertebrobasilar stroke. Am J Transl Res. 2021 Mar 15;13(3):1558-1567. eCollection 2021.
- Results publication: PubMed 32717535Wu L, Jadhav AP, Chen J, Sun C, Ji K, Li W, Zhao W, Li C, Wu C, Wu D, Ji X. Local anesthesia vs general anesthesia during endovascular therapy for acute posterior circulation stroke. J Neurol Sci. 2020 Sep 15;416:117045. doi: 10.1016/j.jns.2020.117045. Epub 2020 Jul 16.
- Results publication: PubMed 28395002Jadhav AP, Bouslama M, Aghaebrahim A, Rebello LC, Starr MT, Haussen DC, Ranginani M, Whalin MK, Jovin TG, Nogueira RG. Monitored Anesthesia Care vs Intubation for Vertebrobasilar Stroke Endovascular Therapy. JAMA Neurol. 2017 Jun 1;74(6):704-709. doi: 10.1001/jamaneurol.2017.0192.
- Results publication: PubMed 29263006Campbell BCV, van Zwam WH, Goyal M, Menon BK, Dippel DWJ, Demchuk AM, Bracard S, White P, Davalos A, Majoie CBLM, van der Lugt A, Ford GA, de la Ossa NP, Kelly M, Bourcier R, Donnan GA, Roos YBWEM, Bang OY, Nogueira RG, Devlin TG, van den Berg LA, Clarencon F, Burns P, Carpenter J, Berkhemer OA, Yavagal DR, Pereira VM, Ducrocq X, Dixit A, Quesada H, Epstein J, Davis SM, Jansen O, Rubiera M, Urra X, Micard E, Lingsma HF, Naggara O, Brown S, Guillemin F, Muir KW, van Oostenbrugge RJ, Saver JL, Jovin TG, Hill MD, Mitchell PJ; HERMES collaborators. Effect of general anaesthesia on functional outcome in patients with anterior circulation ischaemic stroke having endovascular thrombectomy versus standard care: a meta-analysis of individual patient data. Lancet Neurol. 2018 Jan;17(1):47-53. doi: 10.1016/S1474-4422(17)30407-6. Epub 2017 Dec 16.
- Results publication: PubMed 29089457Bouslama M, Haussen DC, Aghaebrahim A, Grossberg JA, Walker G, Rangaraju S, Horev A, Frankel MR, Nogueira RG, Jovin TG, Jadhav AP. Predictors of Good Outcome After Endovascular Therapy for Vertebrobasilar Occlusion Stroke. Stroke. 2017 Dec;48(12):3252-3257. doi: 10.1161/STROKEAHA.117.018270. Epub 2017 Oct 31.
- Results publication: PubMed 33573525Terceno M, Silva Y, Bashir S, Vera-Monge VA, Cardona P, Molina C, Chamorro A, de la Ossa NP, Hernandez-Perez M, Werner M, Camps-Renom P, Rodriguez-Campello A, Canovas D, Purroy F, Serena J; Catalan Stroke Code and Reperfusion Consortium (Cat-SCR). Impact of general anesthesia on posterior circulation large vessel occlusions after endovascular thrombectomy. Int J Stroke. 2021 Oct;16(7):792-797. doi: 10.1177/1747493020976247. Epub 2020 Dec 1.
- Results publication: PubMed 29393092Gory B, Mazighi M, Labreuche J, Blanc R, Piotin M, Turjman F, Lapergue B; ETIS (Endovascular Treatment in Ischemic Stroke) Investigators. Predictors for Mortality after Mechanical Thrombectomy of Acute Basilar Artery Occlusion. Cerebrovasc Dis. 2018;45(1-2):61-67. doi: 10.1159/000486690. Epub 2018 Jan 30.
- Results publication: PubMed 31573636Schonenberger S, Henden PL, Simonsen CZ, Uhlmann L, Klose C, Pfaff JAR, Yoo AJ, Sorensen LH, Ringleb PA, Wick W, Kieser M, Mohlenbruch MA, Rasmussen M, Rentzos A, Bosel J. Association of General Anesthesia vs Procedural Sedation With Functional Outcome Among Patients With Acute Ischemic Stroke Undergoing Thrombectomy: A Systematic Review and Meta-analysis. JAMA. 2019 Oct 1;322(13):1283-1293. doi: 10.1001/jama.2019.11455.
- Results publication: PubMed 32517584Cappellari M, Pracucci G, Forlivesi S, Saia V, Nappini S, Nencini P, Inzitari D, Greco L, Sallustio F, Vallone S, Bigliardi G, Zini A, Pitrone A, Grillo F, Musolino R, Bracco S, Tinturini R, Tassi R, Bergui M, Cerrato P, Saletti A, De Vito A, Casetta I, Gasparotti R, Magoni M, Castellan L, Malfatto L, Menozzi R, Scoditti U, Causin F, Baracchini C, Puglielli E, Casalena A, Ruggiero M, Malatesta E, Comelli C, Chianale G, Lauretti DL, Mancuso M, Lafe E, Cavallini A, Cavasin N, Critelli A, Ciceri EFM, Bonetti B, Chiumarulo L, Petruzzelli M, Giorgianni A, Versino M, Ganimede MP, Tinelli A, Auteri W, Petrone A, Guidetti G, Nicolini E, Allegretti L, Tassinari T, Filauri P, Sacco S, Pavia M, Invernizzi P, Nuzzi NP, Carmela Spinelli M, Amista P, Russo M, Ferrandi D, Corraine S, Craparo G, Mannino M, Simonetti L, Toni D, Mangiafico S. General Anesthesia Versus Conscious Sedation and Local Anesthesia During Thrombectomy for Acute Ischemic Stroke. Stroke. 2020 Jul;51(7):2036-2044. doi: 10.1161/STROKEAHA.120.028963. Epub 2020 Jun 10.
- Results publication: PubMed 33758063Butt W, Dhillon PS, Podlasek A, Malik L, Nair S, Hewson D, England TJ, Lenthall R, McConachie N. Local anesthesia as a distinct comparator versus conscious sedation and general anesthesia in endovascular stroke treatment: a systematic review and meta-analysis. J Neurointerv Surg. 2022 Mar;14(3):221-226. doi: 10.1136/neurintsurg-2021-017360. Epub 2021 Mar 23.
- Results publication: PubMed 28904228Brinjikji W, Pasternak J, Murad MH, Cloft HJ, Welch TL, Kallmes DF, Rabinstein AA. Anesthesia-Related Outcomes for Endovascular Stroke Revascularization: A Systematic Review and Meta-Analysis. Stroke. 2017 Oct;48(10):2784-2791. doi: 10.1161/STROKEAHA.117.017786. Epub 2017 Sep 13.
- Individual participant dataSharing planned: Yes
Related trials for Mechanical Thrombectomy
Not yet recruitingPhase 3
INTRA-ARTERIAL MeVO TREATMENT (IMP-ACT) Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632
Stroke, Acute Ischemic, Medium Vessel Occlusion
Recruiting
Thrombectomy Using Pulsed Aspiration for Reperfusion of Brain Occlusions
Acute Ischemic Stroke
RecruitingObservational study
Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Acute Ischemic Stroke (AIS).
Acute Ischemic Stroke (AIS)
RecruitingObservational study
Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking
Deep Vein Thrombosis (DVT), Thrombus in the Peripheral Venous Vasculature
Recruiting
Endovascular Therapy for Acute Basilar Artery Occlusion With Large Ischemic Core
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Thrombectomy and General Anesthesia, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
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 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: finished, as of the sponsor's last update on 8 Mar 2024. 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 Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional independence at 3 months (time frame: 3 months). 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 NCT05082896, which also lists 11 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 8 Mar 2024.