NCT04063982

Brief Summary

The aim of the observational multicenter trial encompasses the comparison of estimation of the long-term prognosis (functional and cognitive outcomes, quality of life) after intracerebral and subarachnoid hemorrhages assessed by clinical scores, treating physicians and nurses. The scores and the assessment of the treating physicians and nurses are recorded on admission, at 7 and 14 days after symptom onset.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,085

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
completed

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

First Submitted

Initial submission to the registry

April 30, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 21, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

December 12, 2019

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

February 5, 2026

Status Verified

March 1, 2025

Enrollment Period

5.2 years

First QC Date

April 30, 2019

Last Update Submit

February 3, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin Scale dichotomized 0-2 versus 3-6 at 6 months

    Modified Rankin Scale dichotomized 0-2 (good functional outcome) versus 3-6 (poor functional outcome)

    6 months

Secondary Outcomes (6)

  • Modified Rankin Scale dichotomized 0-2 versus 3-6 at 3 months

    3 months

  • Modified Rankin Scale dichotomized 0-3 versus 4-6 at 6 months

    6 months

  • Modified Rankin Scale dichotomized 0-3 versus 4-6 at 3 months

    3 months

  • Quality of life measured by Short Form Health Survey Short Form (SF)-36

    3 and 6 months

  • Quality of life measured by Sickness Impact Profile

    3 and 6 months

  • +1 more secondary outcomes

Interventions

assessment at different time points

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted with acute spontaneous intracerebral and nontraumatic subarachnoid hemorrhage to a center with neurocritical care expertise

You may qualify if:

  • Spontaneous intracerebral hemorrhage or nontraumatic subarachnoid hemorrhage
  • Treatment in Centers with neurocritical care expertise

You may not qualify if:

  • Language other than German and English
  • Restriction of diagnostic and therapeutic measures during acute hospitalization according to advanced directives
  • Admission \> 48 hours after symptom onset
  • Hemorrhage due to trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Charité University Hospital

Berlin, Germany

Location

University Hospital of Duesseldorf

Düsseldorf, Germany

Location

University of Frankfurt

Frankfurt, Germany

Location

Wolf-Dirk Niesen

Freiburg im Breisgau, Germany

Location

University of Leipzig

Leipzig, 04103, Germany

Location

University of Mainz

Mainz, 55131, Germany

Location

Minden Hospital

Minden, Germany

Location

LMU University of Munich

Munich, Germany

Location

Osnabrueck Hospital

Osnabrück, Germany

Location

University Hospital of Regensburg

Regensburg, Germany

Location

MeSH Terms

Conditions

Cerebral HemorrhageSubarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

  • Katja E Wartenberg, MD

    University of Leipzig

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2019

First Posted

August 21, 2019

Study Start

December 12, 2019

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

February 5, 2026

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations