Standard Craniectomy Against Laparotomy for the Treatment of Traumatic Rise in Intracranial Pressure and the Effect on Long-term Outcome

NCT05115929 | Recruiting

• 1 other identifier: 2021_10_SK1
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 4

Brief Summary

Intractable high intracranial pressures (ICP) are associated with poor functional outcomes and mortality, so the SCALPEL trials aims to evaluate the effect of decompressive craniectomy against decompressive laparotomy to lower those pressures in diffuse TBI. The primary outcome measure for that evaluation is functional outcome after 12 months on the extended Glasgow Outcome Scale (GOS-E).

Conditions

Traumatic Brain Injuries

Keywords

Traumatic Brain Injuries; Decompressive Craniectomy; Decompressive Laparotomy

Outcome Measures

Primary Outcomes (1)

• Functional outcome measured by the extended Glasgow Outcome Scale (GOS-E)

  8 Good recovery Upper no current problems related to the brain injury that affect daily life; 7 Good recovery Lower minor problems that affect daily life; resumes \>50% of the pre-injury level of social and leisure activities; 6 Moderate disability Upper reduced work capacity; resumes \<50% of the pre-injury level of social and leisure activities; 5 Moderate disability Lower unable to work or only in sheltered workshop; 4 Sever disability Upper can be left alone \> 8h during the day, but unable to travel and/or go shopping without assistance; 3 Sever disability Lower requires frequent help of someone to be around at home most of the time every day; 2 Persistent vegetative state unresponsive and speechless; 1 Death \[higher scores mean better outcomes\]

  12 months post-injury

Secondary Outcomes (13)

• Mortality

  30 days post-injury

• Serious adverse events and surgical complications measured by the Clavien-Dindo Scale

  30 days post-injury

• Frequency and severity of organ failure

  30 days post-injury

• EQ-5D life quality

  6 and 12 months post-injury

• GCS

  14 days post-injury

Study Arms (2)

Decompressive Craniectomy Group

ACTIVE COMPARATOR

participants with severe TBI randomly assigned as described in the study protocol

Procedure: Decompressive Craniectomy

Decompressive Laparotomy Group

ACTIVE COMPARATOR

participants with severe TBI randomly assigned as described in the study protocol

Procedure: Decompressive Laparotomy

Interventions

Decompressive Laparotomy PROCEDURE

As described in the study protocol a long midline laparotomy is performed and open abdomen therapy using negative pressure dressings initiated to lower abdominal pressure and thereby improve venous return from the brain to lower intracranial pressure.

Decompressive Laparotomy Group

Decompressive Craniectomy PROCEDURE

As described in the study protocol a sufficiently sized hemi-craniectomy is performed and the skin closed over the bony defect to allow cerebral swelling and thereby lower intracranial pressure.

Decompressive Craniectomy Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years
• Traumatic Brain Injury with abnormal CT scan
• Invasive ICP monitoring in place
• ICP \>25 mmHg for 1-12h after conventional therapies step I and step II (see Trial flow chart)

You may not qualify if:

• Bilateral fixed and dilated pupil
• Limitation of therapies by the team due to poor prognosis
• Withdrawal of consent
• Severe pre-existing physical or mental disability or co-morbidity which would lead to a poor outcome even if the patient made a full recovery from the head injury
• Intracranial injury mandating craniotomy/craniectomy in itself
• Intraabdominal injury mandating laparotomy in itself

Sponsors & Collaborators

• Technical University of Munich: lead
• Federal Ministry of Defence (Germany): collaborator
• Bundesministerium der Verteidigung: collaborator

Study Sites (4)

HIA Percy

Clamart, 92140, France

NOT YET RECRUITING

Bundeswehrzentralkrankenhaus Koblenz

Koblenz, 56072, Germany

NOT YET RECRUITING

Department of Neurosurgery - Klinikum rechts der Isar

Munich, 81675, Germany

RECRUITING

Bundeswehrkrankenhaus Ulm

Ulm, 89081, Germany

RECRUITING

Related Publications (1)

• Kolbel B, Novotny A, Willms A, Kehl V, Meyer B, Mauer UM, Krieg SM. Study protocol for a multicenter randomized controlled pilot study on decompressive laparotomy vs. decompressive craniectomy for intractable intracranial pressure after traumatic brain injury: The SCALPEL study. Brain Spine. 2023 Sep 26;3:102677. doi: 10.1016/j.bas.2023.102677. eCollection 2023.

  PMID: 37822567 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Decompressive Craniectomy

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Sandro Krieg, PhD, MBA

CONTACT

+498941407605; sandro.krieg@tum.de

Benny Kölbel, MD, MBA

CONTACT

+49731171033119; bennykoelbel@bundeswehr.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2021
• First Posted: November 10, 2021
• Study Start: October 1, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); FR (1)