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

NCT03766087 | Withdrawn

• 1 other identifier: 18-HPNCL-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• functional neurological status of the patients at 2 years

  Functional neurological status (equating with success of the treatment) will be measure by the Glasgow Outcomes Scale-Extended Pediatric version. Extended GOS (GOSE) provides detailed categorization into eight categories by subdividing the categories of severe disability, moderate disability and good recovery into a lower and upper category. the GOSE range from 1 to 8 (Upper Good Recovery to Death). A score from 3 defines satisfactory functional neurological status. This threshold is selected as it equates to a moderate level of disability, that is to say a child that is autonomous in regard to daily activities and that is able to attend school

  two years after surgery

Secondary Outcomes (9)

• Progression of the IntraCranial Pressure at 24 hours

  24 hours after inclusion

• functional neurological status of the patients at 1 years

  1 year after inclusion

• Evaluation of the overall cognitive functioning

  at 1 year and 2 years after inclusion

• description of surgical parameters patients with successful craniectomy

  at 2 years after craniectomy

• description of clinical parameters patients with successful craniectomy

  at 2 years after craniectomy

Study Arms (2)

surgery group

EXPERIMENTAL

Decompressive craniectomy associated with optimal medical management of intracranial pressure.

Procedure: decompressive craniectomy

conservative group

NO INTERVENTION

Optimal medical management of intracranial pressure only.

Interventions

decompressive craniectomy PROCEDURE

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.

surgery group

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Less than 18 years of age
• Severe traumatic brain injury (initial Glasgow coma scale \< 9)
• Accidental trauma
• Refractory intracranial hypertension: ICP \> 20 mmHg over 30 minutes for children more than one year of age and ICP \> 15 mmHg over 30 minutes for children of less than one year of age.
• The patient must receive optimal medical management
• Affiliation with a social security scheme
• Signed informed consent is to be provided by the two holders of parental authority

You may not qualify if:

• Inflicted cranial trauma (e.g. shaken baby syndrome)
• Patients having an initial surgery for removal of an intracranial hemorrhagic collection of blood (e.g. a subdural hematoma, extradural hematoma, and intraparenchymal hematoma) for which the flap was not replaced.
• Pregnant patient

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

CHU Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Intracranial Hypertension

Interventions

Decompressive Craniectomy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Decompression, Surgical; Surgical Procedures, Operative; Craniotomy; Neurosurgical Procedures

Study Officials

• Michel LONJON, Pr

  Hôpitaux Pédiatriques de Nice CHU-LENVAL

  PRINCIPAL INVESTIGATOR

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: November 19, 2018
• First Posted: December 6, 2018
• Study Start: November 1, 2019
• Primary Completion: January 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)