NCT06638385

Brief Summary

Instead of the standard decompressive hemicraniectomy with subsequent cranioplasty a single surgery with the implantation of an individually molded space-expanding shield is investigated in for patients with increased intracranial pressure due to a malignant stroke.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P75+ for not_applicable stroke

Timeline
50mo left

Started Jun 2025

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

6 active sites

Status
recruiting

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 Progress19%
Jun 2025Jun 2030

First Submitted

Initial submission to the registry

October 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

4.6 years

First QC Date

October 9, 2024

Last Update Submit

July 3, 2025

Conditions

Stroke

Keywords

strokebone flapcranioplasty

Outcome Measures

Primary Outcomes (1)

  • modified Ranking Scale (mRS) score at 6 months

    The primary outcome will be assessed by a blinded, independent, local study nurse. The sole task of this study nurse will be to assess the mRS based on a short interview with the patient.

    6 months after surgery

Secondary Outcomes (8)

  • Number of further surgical interventions for ICP control

    6 months after surgery

  • Occurrence of Hydrocephalus

    6 months after surgery

  • Number of Infections

    6 months after surgery

  • Wound healing difficulties

    6 months after surgery

  • Syndrome of the trephined

    6 months after surgery

  • +3 more secondary outcomes

Study Arms (2)

DCE + SPACE SHIELD

EXPERIMENTAL

Patients in the experimental group receive a DCE with implantation of a space-expanding shield.

Procedure: DCE + SPACE SHIELD

DCE + CP

ACTIVE COMPARATOR

Patients in the control group receive a DCE similar to the intervention group, but without implantation of a space-expanding shield. Cranioplasty (CP) is performed after \~ 90 days in the customary manner.

Procedure: DCE + CP

Interventions

DCE + SPACE SHIELDPROCEDURE

Patients receive a DCE with implantation of a space-expanding shield.

DCE + SPACE SHIELD
DCE + CPPROCEDURE

Patients in the control group receive a DCE similar to the intervention group, but without implantation of a space-expanding shield. Cranioplasty (CP) is performed after \~ 90 days in the customary manner.

DCE + CP

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with malignant infarction of the middle cerebral artery identified by MRI including diffusion-weighted imaging or CT including perfusion imaging - fulfilling the European guidelines for decompressive hemicraniectomy (DCE) for stroke
  • ≥ 18 and \< 70 years of age
  • Availability of consent from a next of kin and from the patient represented by an independent physician

You may not qualify if:

  • Hyperacute need for DCE due to rapid neurological decline
  • Contraindications to the use of polymethyl-methacrylate (PMMA), e.g., known hypersensitivity, allergy
  • Known gentamicin allergy
  • Pregnancy and active breast-feeding
  • Patients with a former history of DCE and/or CP
  • Active pulmonary or cranial infection
  • Known coagulopathy independent of medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Kantonsspital Aarau

Aarau, Switzerland

RECRUITING

Universitätsspital Basel

Basel, Switzerland

RECRUITING

Inselspital Bern, Department of Neurosurgery

Bern, 3010, Switzerland

RECRUITING

Luzerner Kantonsspital

Lucerne, Switzerland

RECRUITING

Ente Ospedaliero Cantonale

Lugano, Switzerland

RECRUITING

Kantonsspital St.Gallen

Sankt Gallen, Switzerland

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

delta 24-sterol reductase

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Schucht Philippe, MD

    Inselspital Bern, Department of Neurosurgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Schucht, MD

CONTACT

+41316322409philippe.schucht@insel.ch

Kissling Cédric, MD

CONTACT

+41316322409space@insel.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2024

First Posted

October 15, 2024

Study Start

June 1, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

June 30, 2030

Last Updated

July 9, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(6)