Multicenter, prospective pediatric craniectomy and cranioplasty registry of the European Society for Pediatric Neurosurgery (ESPN)

Multicenter, prospective pediatric craniectomy and cranioplasty registry of the European Society for Pediatric Neurosurgery (ESPN) - pedCCR

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00027284

Enrollment

150

Registered

2022-03-01

Start date

2022-04-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

S06 I63

Interventions

Group 1: Children with acute severe brain injury, who receive decompressive craniectomy and later cranioplasty

Eligibility

Sex/Gender

All

Age

No minimum to 16 Years

Inclusion criteria

Inclusion criteria: Any type of underlying cerebral insult; Informed consent obtained; Ability to provide follow-up of at least 24 months after cranioplasty

Exclusion criteria

Exclusion criteria: Cranioplasty for conditions other than DC (e.g. congenital skull defects)

Design outcomes

Primary

Measure	Time frame
The primary objective is the assessment of complication rate, functional outcome and quality of life in children after decompressive craniectomy and cranioplasty in a large cohort. This aim is achieved by means of a structured, systematic recording of patient variables as well as parameters of the disease, therapy and the course of the disease at predefined time points (30 days after decompression craniectomy, 30 days after cranioplasty and 12 and 24 months after cranioplasty). Most items are based on the National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements. The following objective scores are used: Pediatric Glasgow Coma Scale (GCS) and Pediatric Risk of Mortality Score (PRISM) as surrogate markers for injury severity, King’s Outcome Scale for Childhood Head Injury (KOSCHI) and KIDSCREEN-10 to measure health-related quality of life and functional outcome as well as the Oulo Resorption Score to measure the extent of autologous bone flap resorption after cranioplasty.	—

Measure

Time frame

The primary objective is the assessment of complication rate, functional outcome and quality of life in children after decompressive craniectomy and cranioplasty in a large cohort. This aim is achieved by means of a structured, systematic recording of patient variables as well as parameters of the disease, therapy and the course of the disease at predefined time points (30 days after decompression craniectomy, 30 days after cranioplasty and 12 and 24 months after cranioplasty). Most items are based on the National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements. The following objective scores are used: Pediatric Glasgow Coma Scale (GCS) and Pediatric Risk of Mortality Score (PRISM) as surrogate markers for injury severity, King’s Outcome Scale for Childhood Head Injury (KOSCHI) and KIDSCREEN-10 to measure health-related quality of life and functional outcome as well as the Oulo Resorption Score to measure the extent of autologous bone flap resorption after cranioplasty.

—

Secondary

Measure	Time frame
The secondary objective is the comparison of treatment strategies and the identification of predictors for optimal results of decompressive craniectomy and cranioplasty by means of a structured, systematic recording of patient variables as well as parameters of the disease, therapy and the course of the disease at predefined time points (30 days after decompressive craniectomy, 30 days after cranioplasty and 12 and 24 months after cranioplasty).	—

Measure

Time frame

The secondary objective is the comparison of treatment strategies and the identification of predictors for optimal results of decompressive craniectomy and cranioplasty by means of a structured, systematic recording of patient variables as well as parameters of the disease, therapy and the course of the disease at predefined time points (30 days after decompressive craniectomy, 30 days after cranioplasty and 12 and 24 months after cranioplasty).

—

Countries

France, Germany, Italy

Contacts

Public ContactThomas Beez

Klinik für Neurochirurgie, Medizinische Fakultät, Heinrich-Heine-Universität Düsseldorf

thomas.beez@med.uni-duesseldorf.de+492118107664

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026