Computed Tomography Angiography Accuracy in Brain Death Diagnosis

NCT ID: NCT02045407

Last Updated: 2019-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2019-01-31

Brief Summary

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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.

Detailed Description

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Critically ill patients, presenting Glasgow Coma Score 5 or lower, will be submitted to the Computed Tomography Angiography (CTA) of the skull assessment, and follow a clinical evaluation for brain death, additionally, transcranial Doppler would be applied as the gold standard for brain death.

We will exclude patients whose do not can be submitted to contrast injection, or if a brain death clinical evaluation has been performed prior the CTA.

Conditions

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Brain Death

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role collaborator

Sergio Brasil, MD MSc

OTHER

Sponsor Role lead

Responsible Party

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Sergio Brasil, MD MSc

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sergio Brasil, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Hospital das Clínicas da Faculdade de Medicina da USP.

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT
PMID: 23609279 (View on PubMed)

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.

Reference Type RESULT
PMID: 22788547 (View on PubMed)

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.

Reference Type RESULT
PMID: 21971739 (View on PubMed)

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.

Reference Type RESULT
PMID: 21168593 (View on PubMed)

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.

Reference Type RESULT
PMID: 20220416 (View on PubMed)

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.

Reference Type RESULT
PMID: 19565357 (View on PubMed)

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.

Reference Type RESULT
PMID: 19406767 (View on PubMed)

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.

Reference Type RESULT
PMID: 9576648 (View on PubMed)

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.

Reference Type RESULT
PMID: 16733422 (View on PubMed)

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.

Reference Type RESULT
PMID: 17275466 (View on PubMed)

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.

Reference Type RESULT
PMID: 17643226 (View on PubMed)

Other Identifiers

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12500913400000068

Identifier Type: -

Identifier Source: org_study_id

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