Aneurysmal Subarachnoid HemorrhagebioSABNCT02142166
The Role of Biomarker in Serum, Cerebrospinal Fluid and Parenchyma in the Context of Aneurysmal Subarachnoid Hemorrhage.
A study testing Biomarker in serum, liquor, micro-dialysate and Biomarker in serum and in liquor in people with Aneurysmal Subarachnoid Hemorrhage, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The aim of this study is to improve the usability of biomarkers for the timely prediction of new complications following a cerebral hemorrhage, especially in combination with invasive, functional and local measurements for patients with aneurysmal subarachnoid hemorrhage (SAH). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- Biomarker in serum, liquor, micro-dialysate and Biomarker in serum and in liquor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Dec 2020
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female, age ≥ 18 years
- signed consent for participation in the study
- signed consent for further analysis of the samples collected during the clinical routine
- in-patients
Who cannot join
- female or male patient <18 years
- pregnancy, lactation
- lack of signed informed consent for participation in the study
- lack of signed consent for the further analysis of the samples collected during the clinical routine
- taking a study drug within the last thirty days
- Simultaneous participation in another clinical trial (except participation as control group)
- persons who are in a dependent relationship or employment with the sponsor or investigator
- persons housed for a judicial or administrative order in an institution
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
Gerrit A. Schubert, PD. Dr., +492418088481, gschubert@ukaachen.de
Gerrit A. Schubert, PD. Dr.
About this study
Official title: Die Rolle Der Biomarker in Serum, Liquor Und Parenchym im Rahmen Der Aneurysmatischen Subarachnoidalblutung: Verlauf Und Korrelation zu Therapie Und Outcome - bioSAB -
The aim of this study is to improve the usability of biomarkers for the timely prediction of new complications following a cerebral hemorrhage, especially in combination with invasive, functional and local measurements for patients with aneurysmal subarachnoid hemorrhage (SAH). Based on analyzed biomarker profiles the chosen therapy efforts are assessed in their immediate and longer-term effectiveness.
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Being tested
- Biomarker in serum, liquor, micro-dialysate, Biomarker in serum and in liquor
- Keywords
- aneurysmal subarachnoid hemorrhage (ASH), biomarker
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker in serum, liquor, micro-dialysateProcedure or surgery
Daily (21 days) analysis of biomarker in serum, in liquor and in micro-dialysate
Biomarker in serum and in liquorProcedure or surgery
Single analysis of biomarker in serum and liquor
| Study group | Role | What they receive |
|---|---|---|
| SAB analysis | Experimental | Patients with acute aneurysmal SAH, confirmed by CT or MRI, or lumbar puncture
Daily (21 days) analysis of Biomarker in serum, in liquor and in micro-dialysate Receives: Procedure: Biomarker in serum, liquor, micro-dialysate |
| Control | Experimental | Patients who undergo a lumbar puncture for myelography as part of the investigation of a cervical or lumbar foraminal stenosis without cranial or myeläre pathology -or- Patients who receive perioperative prophylactic lumbar drainage without cranial or myeläre pathology
Single analysis of Biomarker in serum and liquor Receives: Procedure: Biomarker in serum and in liquor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker in serum, cerebrospinal fluid and parenchyma after aneurysmal SAH
Temporal development of alternative biomarkers in serum, cerebrospinal fluid and parenchyma after aneurysmal SAH, and their response as influenced by the treatment path.
Measured: Each participant will be followed at hospital stay for an expected average of 3 weeks. The outcome measure will be assessed after 24 month.
Secondary outcomes (2)
Clinical outcome
Clinical outcome of patients depending on treatment algorithm and observed development of alternative biomarkers
Measured: Each participant will be followed at hospital stay for an expected average of 3 weeks. The outcome measure will be assessed after 24 month
Image morphological outcome
Image morphological outcome of patients depending on treatment algorithm and observed development of alternative biomarkers
Measured: Each participant will be followed at hospital stay for an expected average of 3 weeks. The outcome measure will be assessed after 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (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 Aneurysmal Subarachnoid HemorrhageStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Albanna, RWTH Aachen University
- Investigators
- Walid Albanna, Priv.-Doz. Dr. med., Principal investigator, Department of Neurosurgery, University Hospital RWTH Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142166
- Sponsor's protocol ID
- CTC-A 14-004
- Acronym
- bioSAB
- Status last verified
- Jan 2020
- First submitted
- 30 Apr 2014
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Neumaier F, Stoppe C, Stoykova A, Weiss M, Veldeman M, Hollig A, Hamou HA, Temel Y, Conzen C, Schmidt TP, Dogan R, Wiesmann M, Clusmann H, Schubert GA, Haeren RHL, Albanna W. Elevated concentrations of macrophage migration inhibitory factor in serum and cerebral microdialysate are associated with delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage. Front Neurol. 2023 Jan 13;13:1066724. doi: 10.3389/fneur.2022.1066724. eCollection 2022.
PubMed 36712451Veldeman M, Weiss M, Albanna W, Nikoubashman O, Schulze-Steinen H, Clusmann H, Hoellig A, Schubert GA. Incremental Versus Immediate Induction of Hypertension in the Treatment of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage. Neurocrit Care. 2022 Jun;36(3):702-714. doi: 10.1007/s12028-022-01466-7. Epub 2022 Mar 8.
PubMed 35260962Conzen C, Weiss M, Albanna W, Seyfried K, Schmidt TP, Nikoubashman O, Stoppe C, Clusmann H, Schubert GA. Baseline characteristics and outcome for aneurysmal versus non-aneurysmal subarachnoid hemorrhage: a prospective cohort study. Neurosurg Rev. 2022 Apr;45(2):1413-1420. doi: 10.1007/s10143-021-01650-x. Epub 2021 Oct 4.
PubMed 34604940Veldeman M, Weiss M, Simon TP, Hoellig A, Clusmann H, Albanna W. Body mass index and leptin levels in serum and cerebrospinal fluid in relation to delayed cerebral ischemia and outcome after aneurysmal subarachnoid hemorrhage. Neurosurg Rev. 2021 Dec;44(6):3547-3556. doi: 10.1007/s10143-021-01541-1. Epub 2021 Apr 17.
PubMed 33866464Veldeman M, Lepore D, Hollig A, Clusmann H, Stoppe C, Schubert GA, Albanna W. Procalcitonin in the context of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage. J Neurosurg. 2020 Sep 4;135(1):29-37. doi: 10.3171/2020.5.JNS201337. Print 2021 Jul 1.
PubMed 32886914
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Die Rolle Der Biomarker in Serum, Liquor Und Parenchym im Rahmen Der Aneurysmatischen Subarachnoidalblutung: Verlauf Und Korrelation zu Therapie Und Outcome - bioSAB -
- ClinicalTrials.gov ID
- NCT02142166
- Acronym / sponsor ID
- bioSAB / CTC-A 14-004
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Keywords
- aneurysmal subarachnoid hemorrhage (ASH), biomarker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 20 May 2014 (estimated)
- 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 aim of this study is to improve the usability of biomarkers for the timely prediction of new complications following a cerebral hemorrhage, especially in combination with invasive, functional and local measurements for patients with aneurysmal subarachnoid hemorrhage (SAH). Based on analyzed biomarker profiles the chosen therapy efforts are assessed in their immediate and longer-term effectiveness.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAB analysis | Experimental | Procedure: Biomarker in serum, liquor, micro-dialysatePatients with acute aneurysmal SAH, confirmed by CT or MRI, or lumbar puncture Daily (21 days) analysis of Biomarker in serum, in liquor and in micro-dialysate |
| Control | Experimental | Procedure: Biomarker in serum and in liquorPatients who undergo a lumbar puncture for myelography as part of the investigation of a cervical or lumbar foraminal stenosis without cranial or myeläre pathology -or- Patients who receive perioperative prophylactic lumbar drainage without cranial or myeläre pathology Single analysis of Biomarker in serum and liquor |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male or female, age ≥ 18 years
- signed consent for participation in the study
- signed consent for further analysis of the samples collected during the clinical routine
- in-patients
Key exclusion criteria (8 listed)
- female or male patient <18 years
- pregnancy, lactation
- lack of signed informed consent for participation in the study
- lack of signed consent for the further analysis of the samples collected during the clinical routine
- taking a study drug within the last thirty days
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 |
|---|---|---|
| Biomarker in serum, liquor, micro-dialysateDaily (21 days) analysis of biomarker in serum, in liquor and in micro-dialysate | Procedure or surgery | SAB analysis |
| Biomarker in serum and in liquorSingle analysis of biomarker in serum and liquor | Procedure or surgery | Control |
Primary outcome
Biomarker in serum, cerebrospinal fluid and parenchyma after aneurysmal SAH
Time frame: Each participant will be followed at hospital stay for an expected average of 3 weeks. The outcome measure will be assessed after 24 month.
Temporal development of alternative biomarkers in serum, cerebrospinal fluid and parenchyma after aneurysmal SAH, and their response as influenced by the treatment path.
2 secondary outcomes
Clinical outcome
Time frame: Each participant will be followed at hospital stay for an expected average of 3 weeks. The outcome measure will be assessed after 24 month
Image morphological outcome
Time frame: Each participant will be followed at hospital stay for an expected average of 3 weeks. The outcome measure will be assessed after 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Derived from this study: PubMed 36712451Neumaier F, Stoppe C, Stoykova A, Weiss M, Veldeman M, Hollig A, Hamou HA, Temel Y, Conzen C, Schmidt TP, Dogan R, Wiesmann M, Clusmann H, Schubert GA, Haeren RHL, Albanna W. Elevated concentrations of macrophage migration inhibitory factor in serum and cerebral microdialysate are associated with delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage. Front Neurol. 2023 Jan 13;13:1066724. doi: 10.3389/fneur.2022.1066724. eCollection 2022.
- Derived from this study: PubMed 35260962Veldeman M, Weiss M, Albanna W, Nikoubashman O, Schulze-Steinen H, Clusmann H, Hoellig A, Schubert GA. Incremental Versus Immediate Induction of Hypertension in the Treatment of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage. Neurocrit Care. 2022 Jun;36(3):702-714. doi: 10.1007/s12028-022-01466-7. Epub 2022 Mar 8.
- Derived from this study: PubMed 34604940Conzen C, Weiss M, Albanna W, Seyfried K, Schmidt TP, Nikoubashman O, Stoppe C, Clusmann H, Schubert GA. Baseline characteristics and outcome for aneurysmal versus non-aneurysmal subarachnoid hemorrhage: a prospective cohort study. Neurosurg Rev. 2022 Apr;45(2):1413-1420. doi: 10.1007/s10143-021-01650-x. Epub 2021 Oct 4.
- Derived from this study: PubMed 33866464Veldeman M, Weiss M, Simon TP, Hoellig A, Clusmann H, Albanna W. Body mass index and leptin levels in serum and cerebrospinal fluid in relation to delayed cerebral ischemia and outcome after aneurysmal subarachnoid hemorrhage. Neurosurg Rev. 2021 Dec;44(6):3547-3556. doi: 10.1007/s10143-021-01541-1. Epub 2021 Apr 17.
- Derived from this study: PubMed 32886914Veldeman M, Lepore D, Hollig A, Clusmann H, Stoppe C, Schubert GA, Albanna W. Procalcitonin in the context of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage. J Neurosurg. 2020 Sep 4;135(1):29-37. doi: 10.3171/2020.5.JNS201337. Print 2021 Jul 1.
Related trials for Aneurysmal Subarachnoid Hemorrhage
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingPhase 2
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Headache
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.
Walid Albanna, Priv.-Doz. Dr. med. principal investigator
Department of Neurosurgery, University Hospital RWTH Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomarker in serum, liquor, micro-dialysate and Biomarker in serum and in liquor in people with Aneurysmal Subarachnoid Hemorrhage, run by RWTH Aachen University 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 4 inclusion and 8 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 5 Feb 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Walid Albanna, Priv.-Doz. Dr. med. (+49 241 80 36706, walbanna@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker in serum, cerebrospinal fluid and parenchyma after aneurysmal SAH (time frame: Each participant will be followed at hospital stay for an expected average of 3 weeks. The outcome measure will be assessed after 24 month.). 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 NCT02142166, 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 5 Feb 2020.