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Studying Anakinra to Reduce Secondary Brain Damage After Spontaneous Haemorrhagic Stroke

NCT04834388 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2024-11-18

No results posted yet for this study

Summary

The goal of this clinical trial\] is to determine if anakinra can ameliorate the formation of perihaematomal oedema in patients with spontaneous intracerebral haemorrhage (ICH). The main aims are:

* To determine the effect of high-dose versus low-dose anakinra compared to standard medical management on perihaematomal oedema formation in the first week after ICH.
* Determine the safety profile of anakinra in these patients
* Study the effect of anakinra treatment on inflammation markers, blood-brain-barrier permeability and functional outcome.

Researchers will compare treatment with anakinra for three days, in either a low or high dose, with standard medical care after ICH. Participants will:

* Be randomized to receive anakinra during three days, or receive standard medical care
* Undergo a MRI scan seven days after their ICH
* Take part in a telephone interview their functional performance three months later.

Conditions

  • Intracerebral Hemorrhage

Interventions

DRUG

Anakinra

Anakinra treatment is started within 8 hours of symptom onset

Sponsors & Collaborators

  • Dutch Heart Foundation

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • F.H.B.M. Schreuder, MD PhD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-10
Primary Completion
2025-09-30
Completion
2025-12-31

Countries

  • Netherlands

Study Locations

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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 NCT04834388 on ClinicalTrials.gov