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

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ClinicalTrials.gov Identifier: NCT03766087
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : May 7, 2021
Sponsor:
Information provided by (Responsible Party):
Fondation Lenval

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.


Condition or disease Intervention/treatment Phase
Hypertension Intracranial Procedure: decompressive craniectomy Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Benefits of Decompressive Craniectomy for Severe Traumatic Brain Injury in Children With Refractory Intracranial Hypertension
Actual Study Start Date : November 29, 2019
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: surgery group
Decompressive craniectomy associated with optimal medical management of intracranial pressure.
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.

No Intervention: conservative group
Optimal medical management of intracranial pressure only.



Primary Outcome Measures :
  1. functional neurological status of the patients at 2 years [ Time Frame: two years after surgery ]

    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



Secondary Outcome Measures :
  1. Progression of the IntraCranial Pressure at 24 hours [ Time Frame: 24 hours after inclusion ]
    the difference between the value of the ICP at 24 hours after inclusion and the value of the ICP at inclusion time

  2. functional neurological status of the patients at 1 years [ Time Frame: 1 year after inclusion ]

    Functional neurological status (equating with success of the treatment) will be measure by the Glasgow Outcomes Scale-Extended Pediatric version.

    A score from 3 defines satisfactory functional neurological status.

    SCORES:

    8 - Death 7 - Vegetative State 6 - Lower Severe Disability 5 - Upper Severe Disability 4 - Lower Moderate Disability 3 - Upper Moderate Disability 2 - Lower Good Recovery

    1 - Upper Good Recovery


  3. Evaluation of the overall cognitive functioning [ Time Frame: at 1 year and 2 years after inclusion ]

    neuropsychological assessment at one year and at two years using the Wechsler intelligence scales. the Wechsler intelligence scales are a Intelligence Quotient tests.

    Five standard tests are done to evaluate: the verbal comprehension index, the fluid reasoning index, the working memory index, and the processing speed index, as well as a total Intelligence Quotient.

    Classification of performance for scaled index scores are as follows:

    Below Average - scaled score 1 to 5 Low Average - scaled score 6 to 7 Average - scaled score 8 to 11 High Average - scaled score 12 to 13 Superior - 14 to 15 Very Superior - 16 to 20

    Descriptors of performance for standard WISC score ranges are as follows:

    Below Average - standard score below 79 Low Average - standard score 80 to 89 Average - 90 to 109 High Average - 110 to 119 Superior - 120 to 129 Very Superior - above 130


  4. description of surgical parameters patients with successful craniectomy [ Time Frame: at 2 years after craniectomy ]

    Collection of surgical parameters of the patient with successful surgery upon admission to resuscitation.

    The objective is to describe the predictive factors of successful craniectomy.


  5. description of clinical parameters patients with successful craniectomy [ Time Frame: at 2 years after craniectomy ]

    Collection of clinical parameters of the patient with successful surgery upon admission to resuscitation.

    The objective is to describe the predictive factors of successful craniectomy.


  6. description of radiological parameters patients with successful craniectomy [ Time Frame: at 2 years after craniectomy ]

    Collection of radiological parameters of the patient with successful surgery upon admission to resuscitation.

    The objective is to describe the predictive factors of successful craniectomy.


  7. number of adverse events linked to surgery [ Time Frame: from inclusion time to the end of patient participation, for about 2 years ]
    collection of adverse events linked to decompressive craniectomy and cranioplasty (infectious, hemorrhagic,cerebrospinal fluid )

  8. Overall survival [ Time Frame: at 3 months and 2 years post cranial trauma ]
    The survival time will be defined as the time between the date of the Crania Trauma and when death occurs from all causes combined.

  9. Evaluation of quality of life [ Time Frame: at 3 months, 1 years and 2 years ]
    measure of quality of life by Lansky scale, is a observational scoring system, in a range of 0-100. 0 represents unresponsive, and 100 represents full active, normal.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766087


Contacts
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Contact: Michel LONJON, Pr 0033492037958 lonjon.m@chu-nice.fr
Contact: Dominique DONZEAU, PhD 0033492034560 donzeau.d@chu-nice.fr

Locations
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France
CHU Angers Not yet recruiting
Angers, France
Contact: Matthieu DELION, Pr         
CHU Bordeaux Not yet recruiting
Bordeaux, France
Contact: Edouard GIMBERT, Pr         
Hôpital Gabriel Montpied Not yet recruiting
Clermont Ferrand, France
Contact: Guillaume COLL, Pr         
CHU Lyon Not yet recruiting
Lyon, France
Contact: Frederico DI ROCCO, Pr         
Hôpital la TIMONE Not yet recruiting
Marseille, France
Contact: Didier SCAVARDA, Pr         
Hôpital Guy de Chauliac Not yet recruiting
Montpellier, France
Contact: Thomas ROUJEAU, Pr         
CHU Nancy Hôpital d'Enfants Not yet recruiting
Nancy, France
Contact: Olivier KLEIN         
Hôpitaux pédiatriques de Nice CHU-Lenval Recruiting
Nice, France, 06200
Contact: Michel LONJON, Pr       lonjon.m@chu-nice.fr   
Contact: Dominique DONZEAU, PhD       donzeau.d@chu-nice.fr   
Hôpital Necker Not yet recruiting
Paris, France
Contact: Kévin BECCARIA, Pr         
CHU Rennes Not yet recruiting
Rennes, France
Contact: Laurent RIFFAUD, Pr         
Hôpital de Hautepierre Not yet recruiting
Strasbourg, France
Contact: François PROUST, Pr         
CHU Hôpital Purpan Not yet recruiting
Toulouse, France
Contact: Sergio BOETTO         
Sponsors and Collaborators
Fondation Lenval
Investigators
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Principal Investigator: Michel LONJON, Pr Hôpitaux Pédiatriques de Nice CHU-LENVAL
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Responsible Party: Fondation Lenval
ClinicalTrials.gov Identifier: NCT03766087    
Other Study ID Numbers: 18-HPNCL-01
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Intracranial Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries