NCT02142166

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

6.7 years

First QC Date

April 30, 2014

Last Update Submit

January 31, 2020

Conditions

Aneurysmal Subarachnoid Hemorrhage

Keywords

aneurysmal subarachnoid hemorrhage (ASH)biomarker

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    Each participant will be followed at hospital stay for an expected average of 3 weeks. The outcome measure will be assessed after 24 month

Study Arms (2)

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

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

Procedure: Biomarker in serum and in liquor

Interventions

Biomarker in serum, liquor, micro-dialysatePROCEDURE

Daily (21 days) analysis of biomarker in serum, in liquor and in micro-dialysate

SAB analysis
Biomarker in serum and in liquorPROCEDURE

Single analysis of biomarker in serum and liquor

Control

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

RECRUITING

Related Publications (5)

  • 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.

    PMID: 36712451DERIVED

  • 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.

    PMID: 35260962DERIVED

  • 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.

    PMID: 34604940DERIVED

  • 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.

    PMID: 33866464DERIVED

  • 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.

    PMID: 32886914DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Biomarkers

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

  • Walid Albanna, Priv.-Doz. Dr. med.

    Department of Neurosurgery, University Hospital RWTH Aachen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Walid Albanna, Priv.-Doz. Dr. med.

CONTACT

+49 241 80 36706walbanna@ukaachen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priv.-Doz. Dr. med. Walid Albanna

Study Record Dates

First Submitted

April 30, 2014

First Posted

May 20, 2014

Study Start

April 1, 2014

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

February 5, 2020

Record last verified: 2020-01

Locations

DE(1)