Computed Tomography Angiography Accuracy in Brain Death Diagnosis

NCT02045407 | Completed DMC

• 1 other identifier: 12500913400000068
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the reliability of computed tomography angiography (CTA) to diagnose brain death, face of several conditions that make impossible to define such diagnosis using clinical criteria exclusively.

Conditions

Brain Death

Keywords

Brain Death; Neurological Death; Cerebral circulatory arrest; Computed Tomography Angiography

Outcome Measures

Primary Outcomes (1)

• Assess the presence or absence of contrast medium filling of the intracranial vessels in comatose patients.

  After excluding confounding factors, we will submit comatose patients to CTA. Immediately after the exam, we will perform clinical evaluation for brain death and calculate CTA sensibility and specificity for this diagnosis. Time between these two interventions will be measured.

  1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals of any genre or age.

You may qualify if:

• Individuals of any age or sex with brain death suspicion raised, before clinical test.
• Comatose patients presenting Glasgow Coma Score as or under 5 points, under sedative agents or not.

You may not qualify if:

• Brain dead patients clinically confirmed.
• Contraindications to the use of contrast medium (renal failure or allergy).

Sponsors & Collaborators

• Sergio Brasil, MD MSc: lead
• University of Sao Paulo: collaborator

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da USP.

São Paulo, 05403000, Brazil

Location

Related Publications (11)

• Welschehold S, Kerz T, Boor S, Reuland K, Thomke F, Reuland A, Beyer C, Tschan C, Wagner W, Muller-Forell W, Giese A. Computed tomographic angiography as a useful adjunct in the diagnosis of brain death. J Trauma Acute Care Surg. 2013 May;74(5):1279-85. doi: 10.1097/TA.0b013e31828c46ba.

  PMID: 23609279 RESULT

• Welschehold S, Kerz T, Boor S, Reuland K, Thomke F, Reuland A, Beyer C, Wagner W, Muller-Forell W, Giese A. Detection of intracranial circulatory arrest in brain death using cranial CT-angiography. Eur J Neurol. 2013 Jan;20(1):173-9. doi: 10.1111/j.1468-1331.2012.03826.x. Epub 2012 Jul 12.

  PMID: 22788547 RESULT

• Rieke A, Regli B, Mattle HP, Brekenfeld C, Gralla J, Schroth G, Ozdoba C. Computed tomography angiography (CTA) to prove circulatory arrest for the diagnosis of brain death in the context of organ transplantation. Swiss Med Wkly. 2011 Oct 4;141:w13261. doi: 10.4414/smw.2011.13261. eCollection 2011.

  PMID: 21971739 RESULT

• Bohatyrewicz R, Sawicki M, Walecka A, Walecki J, Rowinski O, Bohatyrewicz A, Kanski A, Czajkowski Z, Krzysztalowski A, Solek-Pastuszka J, Zukowski M, Marzec-Lewenstein E, Wojtaszek M. Computed tomographic angiography and perfusion in the diagnosis of brain death. Transplant Proc. 2010 Dec;42(10):3941-6. doi: 10.1016/j.transproceed.2010.09.143.

  PMID: 21168593 RESULT

• Berenguer CM, Davis FE, Howington JU. Brain death confirmation: comparison of computed tomographic angiography with nuclear medicine perfusion scan. J Trauma. 2010 Mar;68(3):553-9. doi: 10.1097/TA.0b013e3181cef18a.

  PMID: 20220416 RESULT

• Escudero D, Otero J, Marques L, Parra D, Gonzalo JA, Albaiceta GM, Cofino L, Blanco A, Vega P, Murias E, Meilan A, Roger RL, Taboada F. Diagnosing brain death by CT perfusion and multislice CT angiography. Neurocrit Care. 2009;11(2):261-71. doi: 10.1007/s12028-009-9243-7. Epub 2009 Jun 30.

  PMID: 19565357 RESULT

• Frampas E, Videcoq M, de Kerviler E, Ricolfi F, Kuoch V, Mourey F, Tenaillon A, Dupas B. CT angiography for brain death diagnosis. AJNR Am J Neuroradiol. 2009 Sep;30(8):1566-70. doi: 10.3174/ajnr.A1614. Epub 2009 Apr 30.

  PMID: 19406767 RESULT

• Dupas B, Gayet-Delacroix M, Villers D, Antonioli D, Veccherini MF, Soulillou JP. Diagnosis of brain death using two-phase spiral CT. AJNR Am J Neuroradiol. 1998 Apr;19(4):641-7.

  PMID: 9576648 RESULT

• Leclerc X, Taschner CA, Vidal A, Strecker G, Savage J, Gauvrit JY, Pruvo JP. The role of spiral CT for the assessment of the intracranial circulation in suspected brain-death. J Neuroradiol. 2006 Apr;33(2):90-5. doi: 10.1016/s0150-9861(06)77237-6.

  PMID: 16733422 RESULT

• Combes JC, Chomel A, Ricolfi F, d'Athis P, Freysz M. Reliability of computed tomographic angiography in the diagnosis of brain death. Transplant Proc. 2007 Jan-Feb;39(1):16-20. doi: 10.1016/j.transproceed.2006.10.204.

  PMID: 17275466 RESULT

• Quesnel C, Fulgencio JP, Adrie C, Marro B, Payen L, Lembert N, El Metaoua S, Bonnet F. Limitations of computed tomographic angiography in the diagnosis of brain death. Intensive Care Med. 2007 Dec;33(12):2129-35. doi: 10.1007/s00134-007-0789-6. Epub 2007 Jul 21.

  PMID: 17643226 RESULT

MeSH Terms

Conditions

Brain Death

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sergio Brasil, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 20, 2014
• First Posted: January 24, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2019
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

BR (1)