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Decompressive Craniectomy for Severe Traumatic Brain Injury in Children With Refractory Intracranial Hypertension

NCT03766087 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-05-19

No results posted yet for this study

Summary

Severe traumatic brain injury (TBI) is the leading cause of mortality and severe disability in the pediatric population. The prognosis of these patients depends on the severity of the initial lesions but also on the effectiveness of the therapies used to prevent or at least limit secondary lesions mainly intracranial hypertension (HTIC).

The medical therapeutic strategy for the control of HTIC in children with TBI is well codified: starting with hyperosmolar therapy, then hyperventilation and ultimately the use of barbiturates to deepen sedation. However, these therapies are not devoid of adverse effects (hypernatremia, cerebral hypoxemia, systemic vasodilation) and, for some, their efficacy is diminished over time. When these treatments are insufficient to lower intracranial pressure (ICP), decompressive craniectomy is proposed. Decompressive craniectomy is used in a well-coded manner in malignant ischemic stroke in adults.

In TBI, to date, there are two randomized studies in adults and one in children but with a small number of patients, evaluating the benefit of decompressive craniectomy. None of them showed significantly superiority of the surgery compared to the maximal medication treatment on the functional prognosis in the medium term.

However, these studies have many biases, including a significant cross-over from the conservative treatment group to the surgery arm.

Nevertheless, the pediatric literature on the subject seems to yield better results on neurological prognosis in the long term. There are guidelines on the medical management of childhood TBI published by the National Institute of Health in 2012, which emphasize the need for controlled and randomized studies to define the place of decompressive craniectomy in children. That is why the investigators are proposing this national multicentre study.

Conditions

  • Hypertension Intracranial

Interventions

PROCEDURE

decompressive craniectomy

decompressive craniectomy is decompression at the supratentorial level that is achieved by removing part of the skull and by making an opening, in the dura mater (with or without plastic surgery), without compromising the venous sinus.

Sponsors & Collaborators

  • Fondation Lenval

    lead OTHER

Principal Investigators

  • Michel LONJON, Pr · Hôpitaux Pédiatriques de Nice CHU-LENVAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-30
Primary Completion
2025-01-31
Completion
2025-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03766087 on ClinicalTrials.gov