Overview

This trial is active, not recruiting.

Condition brain injuries, traumatic
Treatment emergent craniotomy for traumatic brain injury
Sponsor Universitaire Ziekenhuizen Leuven
Start date February 2010
End date January 2016
Trial size 67 participants
Trial identifier NCT02803112, S59232

Summary

The investigators aim to retrospectively map the delays in the acute care of traumatic brain injury patients necessitating emergent craniotomies.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective

Primary Outcomes

Measure
Temporal delay between emergency call and the surgical skin incision.
time frame: From the trauma onset until 24 hours after the trauma onset.

Secondary Outcomes

Measure
Temporal delay between emergency call and arrival at our emergency department.
time frame: From the trauma onset until 24 hours after the trauma onset.
Temporal delay between arrival at our emergency department and acquisition of the first head CT slice.
time frame: From the trauma onset until 24 hours after the trauma onset.
Temporal delay between acquisition of the first head CT slice and arrival in the operating room.
time frame: From the trauma onset until 24 hours after the trauma onset.
Glasgow Outcome Scale
time frame: 6 months after the trauma

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - every patient undergoing 1 of 3 surgical procedures ('removal of epidural hematoma'; 'removal of acute subdural hematoma'; and 'decompressive craniectomy'), performed between February 1, 2010 and January 31, 2016, as recorded in the surgical database of our institution. Exclusion Criteria: - who had a delayed clinical or radiological deterioration as a surgical indication; - who did not have traumatic brain injury as the origin of the intracranial abnormalities; - in whom not all aforementioned temporal or clinical data were readily available from the electronic patient file; and/or - who were not admitted via our emergency department.

Additional Information

Official title Pre-hospital and Intra-hospital Temporal Delays in Patients Requiring Emergent Trauma Craniotomy. A 6-year Retrospective Analysis in a Level 1 Trauma Center
Principal investigator Bart Depreitere, MD, PhD
Description Despite the high incidence of traumatic brain injury (TBI) and the high numbers of emergent craniotomies for TBI performed worldwide, publications reporting on temporal delays in these patients are very scarce. To the best of the investigators' knowledge, there are only 3 publications providing data on the intra-hospital delay and no publications on pre-hospital delay specifically for TBI patients undergoing emergent craniotomies. The aim of the present study is to retrospectively map delays between the emergency call of the national emergency telephone dispatch to the hospital's medical emergency service (EC) and the surgical skin incision in emergent TBI craniotomies in the investigators' level 1 trauma center and to propose possible measures to improve performance.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Universitaire Ziekenhuizen Leuven.