Brain Tumor, RecurrentNCT03666507
Vegetative Monitoring During Brainstem-associated Surgery
An observational study of Brain Tumor, Recurrent and Vestibular Schwannoma, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Intraoperative Monitoring of Heart rate variability, Blood pressure variability, Baroreceptorsensivity etc. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Tumor, Recurrent, Vestibular Schwannoma, Brainstem Neoplasm
- What is being tested?
- Intraoperative Monitoring during resection of brain tumor
- Type of treatment
- Surgery or procedure
- How many people
- 103 participants
- Where
- 1 siteGermany
- Study dates
- 28 Aug 2018to 28 Mar 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Brain tumor patients
Who may be able to join
- age 0-99
- brain tumor
Who cannot join
- no consent
Trial locations and contacts
1 site in 1 country.
About this study
Intraoperative Monitoring of Heart rate variability, Blood pressure variability, Baroreceptorsensivity etc.
- Being tested
- Intraoperative Monitoring during resection of brain tumor
- Medical subject headings
- Brain Neoplasms, Neuroma, Acoustic, Brain Stem Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Monitoring during resection of brain tumorProcedure or surgery
Intraoperative Monitoring during resection of brain tumor
| Study group | Role | What they receive |
|---|---|---|
| Brain stem associated tumors | Brain stem associated tumors Receives: Procedure: Intraoperative Monitoring during resection of brain tumor | |
| Tumors without brain stem assocation | Tumors without brain stem assocation Receives: Procedure: Intraoperative Monitoring during resection of brain tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability (HRV)
Comparison of HRV in the 2 groups (brain stem-associated vs. non associated surgery)
Measured: intraoperatively
Secondary outcomes (1)
Rate of cardiovascular complications
Comparison of no. of cardiovascular complications (cardiac arrest, sudden tachy/bradyarryhthmia, hyper/hypotension, trigeminocardiac reflex) in the 2 groups
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start28 Aug 2018
- Primary completion28 Aug 2020
- Study completion28 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumor, RecurrentStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin U Schuhmann, Prof, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666507
- Sponsor's protocol ID
- ANSTue
- Status last verified
- Apr 2021
- First submitted
- 30 Aug 2018
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vegetative Monitoring During Brainstem-associated Surgery
- ClinicalTrials.gov ID
- NCT03666507
- Acronym / sponsor ID
- ANSTue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 28 Mar 2021 (actual)
- First posted
- 11 Sep 2018 (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.
Intraoperative Monitoring of Heart rate variability, Blood pressure variability, Baroreceptorsensivity etc.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain stem associated tumors | – | Procedure: Intraoperative Monitoring during resection of brain tumorBrain stem associated tumors |
| Tumors without brain stem assocation | – | Procedure: Intraoperative Monitoring during resection of brain tumorTumors without brain stem assocation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Brain tumor patients
Key inclusion criteria (2 listed)
- age 0-99
- brain tumor
Key exclusion criteria (1 listed)
- no consent
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 |
|---|---|---|
| Intraoperative Monitoring during resection of brain tumorIntraoperative Monitoring during resection of brain tumor | Procedure or surgery | Brain stem associated tumors, Tumors without brain stem assocation |
Primary outcome
Heart rate variability (HRV)
Time frame: intraoperatively
Comparison of HRV in the 2 groups (brain stem-associated vs. non associated surgery)
1 secondary outcome
Rate of cardiovascular complications
Time frame: intraoperatively
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 4 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Brain Tumor, Recurrent
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Active, not recruitingPhase 3
Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM
Glioblastoma, Recurrent Glioblastoma
RecruitingPhase 1
PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy
Neuroblastoma, Diffuse Intrinsic Pontine Glioma
RecruitingPhase 1
A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
Glioblastoma Multiforme of Brain, Glioma
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.
Martin U Schuhmann, Prof principal investigator
University Hospital Tuebingen
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 Brain Tumor, Recurrent and Vestibular Schwannoma, run by University Hospital Tuebingen at 1 site in Germany.
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 2 inclusion and 1 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 4 Nov 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 Germany. 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?
Heart rate variability (HRV) (time frame: intraoperatively). 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 4 Nov 2022.