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

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ClinicalTrials.gov Identifier: NCT05115929
Recruitment Status : Not yet recruiting
First Posted : November 10, 2021
Last Update Posted : November 10, 2021
Sponsor:
Collaborator:
Federal Ministry of Defence (Germany)
Information provided by (Responsible Party):
Technische Universität München

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).

Condition or disease Intervention/treatment Phase
Traumatic Brain Injuries Procedure: Decompressive Laparotomy Procedure: Decompressive Craniectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Standard Craniectomy Against Laparotomy for the Treatment of Traumatic Rise in Intracranial Pressure and the Effect on Long-term Outcome
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : August 2026

Arm Intervention/treatment
Active Comparator: Decompressive Craniectomy Group
participants with severe TBI randomly assigned as described in the study protocol
Procedure: Decompressive Craniectomy
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.

Active Comparator: Decompressive Laparotomy Group
participants with severe TBI randomly assigned as described in the study protocol
Procedure: Decompressive Laparotomy
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.




Primary Outcome Measures :
  1. Functional outcome measured by the extended Glasgow Outcome Scale (GOS-E) [ Time Frame: 12 months post-injury ]

    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]



Secondary Outcome Measures :
  1. Mortality [ Time Frame: 30 days post-injury ]
  2. Serious adverse events and surgical complications measured by the Clavien-Dindo Scale [ Time Frame: 30 days post-injury ]

    Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside.

    Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications.

    Blood transfusions and total parenteral nutrition are also included.

    Grade III Requiring surgical, endoscopic or radiological intervention

    • IIIa Intervention not under general anesthesia
    • IIIb Intervention under general anesthesia

    Grade IV Life-threatening complication (including centralnervous complications)* requiring intensive care management

    • IVa single organ dysfunction (including dialysis)
    • IVb multi organ dysfunction Grade V Death of a patient

  3. Frequency and severity of organ failure [ Time Frame: 30 days post-injury ]
  4. EQ-5D life quality [ Time Frame: 6 and 12 months post-injury ]
    European Quality of Life Questionnaire [minimum 1, maximum 5, lower scores mean better outcomes]

  5. GCS [ Time Frame: 14 days post-injury ]
    Glasgow Coma Scale at discharge from intensive care [minimum 3, maximum 15; higher scores mean better outcomes]

  6. Crossover-rate [ Time Frame: 30 days post-injury ]
    Crossover-Rate: Participants who received an additional decompressive laparotomy after being randomly assigned to the decompressive craniectomy arm and Participants who received an additional decompressive craniectomy after being randomly assigned to the decompressive laparotomy arm.

  7. Course of intracranial pressure [ Time Frame: while in ICU for up to 14 days or until ICU discharge, whatever occurs first ]
    measured in mmHg

  8. Intraabdominal pressure [ Time Frame: while in ICU for up to 14 days or until ICU discharge, whatever occurs first ]
    measured in mmHg

  9. Mean airway pressure [ Time Frame: for up to 14 days or until ICU discharge, whatever occurs first ]
    measured in mbar

  10. Hernia rate in the laparotomy group [ Time Frame: 12 months post-injury ]
    rate of ventral incisional hernia post-laparotomy

  11. Length of stay at the intensive care unit [ Time Frame: up to 12 months ]
    measured in days

  12. Length of stay at the neurosurgical unit [ Time Frame: up to 12 months ]
    measured in days

  13. Length of stay at the intensive care unit (ICU), neurosurgical unit, and rehabilitation unit [ Time Frame: up to 12 months ]
    measured in days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Bilateral fixed and dilated pupil
  2. Limitation of therapies by the team due to poor prognosis
  3. Withdrawal of consent
  4. 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
  5. Intracranial injury mandating craniotomy/craniectomy in itself
  6. Intraabdominal injury mandating laparotomy in itself

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): NCT05115929


Contacts
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Contact: Sandro Krieg, PhD, MBA +498941407605 sandro.krieg@tum.de
Contact: Benny Kölbel, MD, MBA +49731171033119 bennykoelbel@bundeswehr.org

Locations
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France
HIA Percy
Clamart, France, 92140
Contact: Jean-Marc Delmas, PhD         
Principal Investigator: Jean-Marc Delmas, PhD         
Germany
Bundeswehrzentralkrankenhaus Koblenz
Koblenz, Germany, 56072
Contact: Arnulf Willms, PhD    +4926128122801    arnulfwillms@bundeswehr.org   
Principal Investigator: Arnulf Willms, PhD         
Department of Neurosurgery - Klinikum rechts der Isar
Munich, Germany, 81675
Contact: Sandro Krieg, PhD, MBA    +4989-4140-7605    sandro.krieg@tum.de   
Principal Investigator: Sandro Krieg, PhD, MBA         
Bundeswehrkrankenhaus Ulm
Ulm, Germany, 89081
Contact: Benny Kölbel, MD, MBA    +49731171033119    bennykoelbel@bundeswehr.org   
Principal Investigator: Benny Kölbel, MD, MBA         
Sponsors and Collaborators
Technische Universität München
Federal Ministry of Defence (Germany)
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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT05115929    
Other Study ID Numbers: 2021_10_SK1
First Posted: November 10, 2021    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: October 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
Keywords provided by Technische Universität München:
Traumatic Brain Injuries
Decompressive Craniectomy
Decompressive Laparotomy
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries