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Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage

NCT05132920 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2023-05-10

No results posted yet for this study

Summary

Aneurysmal subarachnoid hemorrhage (SAH) is a fatal disease with high morbidity and mortality. While the primary injury results from the initial bleeding and cannot be influenced, secondary injury through vasospasms and delayed cerebral ischemia (DCI) during the course of the disease might be a target for intervention in order to improve outcome. To date, beside the aneurysm treatment to prevent re-bleeding and the administration of oral nimodipine, there is no causal therapy available, so that novel treatment concepts are desperately needed. There are strong indications that inflammation contributes to DCI and therefore poor outcome and plays a major role in SAH. Some studies suggest a beneficial effect of anti-inflammatory drugs like glucocorticoids (GC) in SAH patient, but there are no data from randomized controlled trials proving or disproving the beneficial effect of GC, so that current guidelines do not recommend the use of GC in SAH so far.

This multi-center trial aims to generate the first confirmatory data in a controlled randomized fashion that dexamethasone (DEX) improves the outcome in a clinically relevant endpoint in SAH patients. Moreover, this trial will generate first data in a secondary analysis, whether the initial inflammatory state of SAH patients defines a subgroup that particularly responds to a treatment with DEX.

Conditions

  • Aneurysmal Subarachnoid Hemorrhage

Interventions

DRUG

Dexamethasone

3 x 8 mg dexamethasone daily for days 1-7 and 1 x 8 mg dexamethasone daily for days 8-21

DRUG

Placebo

3 x 2 ml Placebo daily for days 1-7 and 1 x 2 ml Placebo daily for days 8-21

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • Pharmacy of the University Hospital Leipzig- AöR

    collaborator UNKNOWN

  • nextevidence GmbH

    collaborator UNKNOWN

  • University Hospital, Bonn

    lead OTHER

Principal Investigators

  • Erdem Güresir, Prof. Dr. · Department of Neurosurgery, University Hospital Leipzig

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-03
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05132920 on ClinicalTrials.gov