Clinical trial NCT02142166: The Role of Biomarker in Serum, Cerebrospinal Fluid and Parenchyma in the Context of Aneurysmal Subarachnoid Hemorrhage.
Official title: Die Rolle Der Biomarker in Serum, Liquor Und Parenchym im Rahmen Der Aneurysmatischen Subarachnoidalblutung: Verlauf Und Korrelation zu Therapie Und Outcome - bioSAB -
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aneurysmal Subarachnoid Hemorrhage
Keywords: aneurysmal subarachnoid hemorrhage (ASH)
biomarker
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2014-05-20
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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). Based on analyzed biomarker profiles the chosen therapy efforts are assessed in their immediate and longer-term effectiveness.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Biomarker in serum, cerebrospinal fluid and parenchyma after aneurysmal SAH
timeFrame: 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:
measure: Clinical outcome
timeFrame: Each participant will be followed at hospital stay for an expected average of 3 weeks. The outcome measure will be assessed after 24 month
measure: Image morphological outcome
timeFrame: Each participant will be followed at hospital stay for an expected average of 3 weeks. The outcome measure will be assessed after 24 month
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Neurosurgery, University Hospital RWTH Aachen
state: NRW
Study officials:
affiliation: Department of Neurosurgery, University Hospital RWTH Aachen
name: Walid Albanna, Priv.-Doz. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Veldeman 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.
citation: Conzen 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.
citation: Veldeman 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.
citation: Veldeman 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.