NCT04574349

Brief Summary

A prospective clinical trial on trauma patients with increased intracranial pressure(ICP) applied for decompressive craniectomy to lower ICP

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

September 26, 2020

Last Update Submit

September 30, 2020

Conditions

Head Injury Trauma

Outcome Measures

Primary Outcomes (2)

  • Change of the patient's condition clinically

    Clinically: Change of Glasgow Coma Scale (GCS). Maximum value is 15 Minimum value is 3

    one year

  • Change of the patient's condition radiologically

    By CT brain

    One year

Interventions

Decompressive craniectomyPROCEDURE

Removing part of the skull (bone flap) to lower intracranial pressure

Eligibility Criteria

AgeUp to 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All Patients with signs of increased intracranial tension (subdural hematoma, brain edema, intracerebral hematoma) after trauma diagnosed clinically, radiologically, and resistant to medical decompression.
  • Age: up to 60
  • Midline shift more than 5 mm.
  • GCS \> 8

You may not qualify if:

  • Age: more than 60
  • Old trauma
  • Unfit for surgery (ex: cardiac patient)
  • GCS \< 8
  • Midline shift less than 5 mm.
  • Unwillingness to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (1)

  • 1. Wilson MH, Kolias AG, Hutchinson PJ. Neurotrauma - a multidisciplinary disease. Int J clic pract 2014;68:5-7. 2. Kolias AG, Kirkpatrick PJ, Hutchinson PJ. Decompressive craniectomy: past, present, and future. Nat Rev Neurol 2013;9:405-15. 3. Sahuquillo J, Arikan F. Decompressive craniecomty for the treatment of refractory high intracranial pressure in traumatic brain injury. Cochrane Database Syst Rev 2010;CD003983. 4. Cushing G. I. subtemporal Decompressive Opertions for the intracranial Complications Associated with Bursting Fractures of the Skull. Ann Surg 1908;47:641-4.1 5. Polin RS, Shaffrey ME, Bogaev, et al. Decompressive bifrontal craniectomy in the treatment of severe refractory posttraumatic cerebral edema. Neurosugery 2015;41:84-92. 6. Whitfield PC, Patel H, Hutchinson PJ, et al. Bifrontal decompressive craniectomy in the management of posttraumatic intracranial hypertension. Br J Neurosurg 2014;15:500-7. 7. De luca GP, Volpin L, Fornezza U, Cervellini P, Zanusso M, Casentini L, Curri D, Piacentino M, Bozzato G, Colombo F, The role of decompressive craniectomy in the treatment of uncontroolable pos-traumatic intracranial hypertension. Acta Neurichir (Suppl) 2000;76:401-404. 8. Faul, F., Erdfelder, E., Lang, A.-G. & Buchner, A. G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 2014;39, 175-191.. 9. I. Timofeev, P.J.Kirkpatrick, E.Corteen, M.Hiller, M.Czosnyka, D.K.Menon, J.D.Pickard, and P.J.Hutchinson Decompressive craniectomy in traumatic brain injury 2006;96:11-16 10. Teasdale G, Jennett B. Assessment of coma and impaired consciousness. Lancet 1974; 81-84 11. Teasdale G, Jennett B. Assessment and prognosis of coma after head injury. Acta Neurochir 1976; 34:45-55.

    BACKGROUND

MeSH Terms

Interventions

Decompressive Craniectomy

Intervention Hierarchy (Ancestors)

Decompression, SurgicalSurgical Procedures, OperativeCraniotomyNeurosurgical Procedures

Study Officials

  • Roshdy A Elkhayat, Professor

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa M Oreaby

CONTACT

01008798181alaaoreaby@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer at neurosurgery department, Assiut University

Study Record Dates

First Submitted

September 26, 2020

First Posted

October 5, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

October 5, 2020

Record last verified: 2020-09

Locations

EG(1)