NCT04791904

Brief Summary

This is a single-center, observational retrospective study. This study aims to identify predictive factors of complications for patients submitted to cranioplasty after decompressive craniectomy for all types of etiologies. All patients submitted to cranioplasty since 2008 will be analyzed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

1.9 years

First QC Date

March 6, 2021

Last Update Submit

August 20, 2022

Conditions

Decompressive Craniectomy and Cranioplasty

Keywords

CranioplastySurgery ComplicationsDecompressive Craniectomy

Outcome Measures

Primary Outcomes (1)

  • Surgical Complications

    Complications after cranioplasty - symptomatic hemorrhage, infection, re-intervention.

    6 months

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients submitted to cranioplasty after decompressive craniectomy between 1 of January of 2008 and 21 of December of 2019.

You may qualify if:

  • Cranioplasty surgery
  • Previous decompressive craniectomy

You may not qualify if:

  • Incomplete records (Clinical and Imaging) since craniectomy to 6 months after cranioplasty.
  • More than one decompressive craniectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Hospitalar Universitário de São João

Porto, Portugal

Location

Study Officials

  • Pedro Silva, MD

    University of Porto, Medicine Faculty

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2021

First Posted

March 10, 2021

Study Start

September 1, 2020

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

August 24, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)