Trial document




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  DRKS00017650

Trial Description

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Title


Primary decompressive craniectomy in aneurysmal subarachnoid hemorrhage

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Trial Acronym

PICASSO

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The purpose of this clinical study is to investigate whether in patients with aneurysmatic cerebral hemorrhage, early removal of the cranial bone (decompressive craniectomy) reduces the pressure of the cerebral hemorrhage on the undamaged brain tissue, possibly reducing mortality and long-term disability. With this clinical study we aim to compare the effectiveness of this treatment strategy with the standard therapy.

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Brief Summary in Scientific Language

Aim of this randomized, controlled study is to analyse if primary decompressive craniectomy combined with the best medical therapy in patients with poor-grade aneurysmal subarachnoid hemorrhage improves the clinical outcome in comparison to best medical therapy alone and secondary craniectomy as ultima ratio therapy for increased intracranial pressure.

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Organizational Data

  •   DRKS00017650
  •   2019/09/06
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  •   yes
  •   Approved
  •   179/19, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

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Health Condition or Problem studied

  •   I60 -  Subarachnoid haemorrhage
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Interventions/Observational Groups

  •   Primary decompressive craniectomy (PDC; within the first 24 hours after bleeding) combined with the best medical therapy including reinsertion of the cranial bone flap after approximately 90 days.
  •   Best possible neurointensive medical therapy according to international guidelines. It may include a secondary decompressive craniectomy as ultima ratio therapy for reducing increased intracranial pressure.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Comparison of the combination of mortality and severe disability be-tween study arms, assessed by the modified Rankin Scale (mRS; com-monly used scale for measuring the degree of disability or dependence in the daily activities of people after stroke) between both study arms 12 months after the subarachnoid hemorrhage. - dichotomized in “favoura-ble (mRS 0-4) versus “unfavourable “ (mRS 5-6) outcome.

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Secondary Outcome

1 a) Analysis of mortality at 7 and 90 days and at 12 and 24 months
1 b) Comparison of date of death in patients with PDC vs. noPDC after aSAH
2 a) Comparison of length of ICU-stay in patients with PDC vs. noPDC after aSAH
2 b) Comparison of length of hospital stay in patients with PDC vs. noPDC after aSAH
3) Evaluation of the rate of secondary decompressive craniectomy due to intractably raised ICP.
4) Evaluation of use of duraplasty after craniectomy
5) Evaluation of correlation between size of craniectomy and clinical outcome
6) Rate of complications due to craniectomy assessed by adverse events
7) Analysis of mRS in patients with PDC vs. noPDC before aSAH and 10-14 days, 30 days, 90 days, 180 days and 2 years (long-term fol-low-up) after aSAH
8) Analysis of SF36 scores and EQ-ED scores in patients with PDC vs. noPDC 12 months after aSAH

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/09/12
  •   216
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

Subjects will only be included in the study if they meet all of the fol-lowing criteria:
- Male or female subjects, age ≥ 18 years and ≤ 80 years old
- Aneurysmal subarachnoid hemorrhage
- WFNS (grading system used to classify the severity of a sub-arachnoid hemorrhage based on the patients initial clinical condi-tion) grade 4 or 5 at admission
- Operation can be performed within the first 24 hours after symp-toms of hemorrhage have started
- Early aneurysm treatment must be deemed possible in order to perform primary decompressive craniectomy within 24h after symptoms of hemorrhage have started if randomized in arm A.

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Exclusion Criteria

Subjects will not be included in the study if any of the following criteria applies:

- Moribund patient (before subarachnoid hemorrhage) due to other illness
- SAH due to any other cause than aneurysm rupture (traumatic, arteriovenous malformation (AVM), fistula, dissection)
- Patients with foreseeable difficulties to perform the follow-up adequatelyin
- Strong indication of inability (before aSAH) to understand and respond to questions in German
- Any condition that, in the judgement of the Investigator, could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study
- Patients with obvious evidence of irreparable brainstem or thalamic injury

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Addresses

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    • Universitätsklinik für Neurochirurgie
    • Mr.  Prof. Dr. med.  Erdem  Güresir 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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    • Studienzentrum Bonn (SZB) Studienzentrale, Institut für Klinische Chemie und Klinische Pharmakologie, Universitätsklinikum Bonn
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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    • Universitätsklinik für Neurochirurgie
    • Mr.  Prof. Dr. med.  Erdem  Güresir 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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    • Universitätsklinik für Neurochirurgie
    • Mr.  Prof. Dr. med.  Erdem  Güresir 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Förderinstrument für klinische Studien der Medizinischen Fakultät der Universität Bonn
    • Venusberg-Campus 1
    • 53105   Bonn
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.