Computed Tomography Angiography Accuracy in Brain Death Diagnosis

Brain Death Clinical Trial

Official title:

Computed Tomography Angiography Accuracy in Brain Death Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02045407
• Other study ID #: 12500913400000068
• Status: Completed
• Start date: January 2014
• Est. completion date: January 2019

Study information

• Verified date: July 2019
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: January 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Brain Death
• Death

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da USP.	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Sergio Brasil, MD MSc	University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (11)

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. — View Citation

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 brai — View Citation

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. — View Citation

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. — View Citation

Escudero D, Otero J, Marqués L, Parra D, Gonzalo JA, Albaiceta GM, Cofiño 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/s — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Jul 21. — View Citation

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. do — View Citation

Welschehold S, Kerz T, Boor S, Reuland K, Thömke F, Reuland A, Beyer C, Tschan C, Wagner W, Müller-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. d — View Citation

Welschehold S, Kerz T, Boor S, Reuland K, Thömke F, Reuland A, Beyer C, Wagner W, Müller-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.1468-1 — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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