DECT for Differentiating Intracerebral Hemorrhage From Contrast Extravasation

NCT05675774 | Completed

• 1 other identifier: HS25711 (B2022:097)
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the use of DECT (Dual-Energy Computed Tomography) in patients with acute ischemic stroke who receive an intervention (thrombolysis or thrombectomy). The main questions to answer are:

1. 1.Can DECT more accurately differentiate hyperdensities as intracranial haemorrhage (ICH) or contrast extravasation compared with single-energy CT (SECT)?.
2. 2.Will DECT lead to better care for patients with AIS who receive intervention and have post-procedural hyperdensities?

Conditions

Stroke, Ischemic; Tomography, X-Ray Computed

Keywords

Thrombectomy; Cerebral Hemorrhage; Extravasation of Diagnostic and Therapeutic Materials; Thrombolytic Therapy

Outcome Measures

Primary Outcomes (1)

• The presence or absence of intracerebral hemorrhage on DECT scans

  The study population will first be separated into two categories: patients 1) with and 2) without hyperdensity seen on post-24 hour CT scan. DECT will be performed on both of these two groups. Of the patients with hyperdensity, we will further categorize them into two groups: 1) confirmed ICH and 2) confirmed CE or no hemorrhage. In DECT, three different images are obtained, one at high energy, one at low energy, and a mixed image. There are three parameters to separate ICH from CE on DECT: 1) if a hyperdensity is seen on the mixed-energy image and low-energy image but not the high-energy image it is ICH, 2) if a hyperdensity is seen on the mixed-energy image and the high-energy image but not the low-energy image, it is CE.

  24 hours post intervention

Secondary Outcomes (3)

• Length of Stay

  Assessed up to 90 days

• Type of Intracerebral Hemorrhage (ICH)

  Assessed up to 24 hours over which ICH is confirmed on imaging

• Level of Disability at 90 days post-stroke

  90 days post date of first symptoms of acute stroke

Study Arms (1)

Dual Energy CT

EXPERIMENTAL

Patients with acute stroke who receive intervention in the form of thrombolysis or EVT will receive dual-energy CT at the 24-hour mark in lieu of conventional single-energy CT.

Diagnostic Test: Dual Energy CT

Interventions

Dual Energy CT DIAGNOSTIC_TEST

Patients with acute stroke who receive intervention will undergo dual-energy CT in lieu of single-energy CT at 24 hours post-intervention.

Also known as: DECT

Dual Energy CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients greater than or equal to 18 years of age presenting with acute ischemic stroke (AIS) that are candidates for 1) thrombolysis (tPA) and/or 2) endovascular thrombectomy (EVT)

You may not qualify if:

• Patients who are not candidates for tPA:
• Intracerebral Hemorrhage on CT Ischemic Stroke within 3 months, Severe head trauma within 3 months Acute head trauma GI Malignancy or BI bleed within 21 days Coagulopathy (Platelets \<100,000/mm3, INR \>1.7, aPTT \>40s, PT\>15s) Anticoagulation (thrombin inhibitors, factor Xa inhibitors, low-molecular weight heparin) History of intracranial hemorrhage Intra-axial neoplasm Infective endocarditis Aortic Arch Dissection Patient receiving IV aspirin Patient receiving IV abciximab
• Patients who are not candidates for EVT:
• No large vessel occlusion on CT angiogram Baseline Modified Rankin Scale \>3 No significant perfusion mismatch

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Sciences Center

Winnipeg, Manitoba, R3E 3P5, Canada

Location

Related Publications (17)

• Powers WJ. Acute Ischemic Stroke. N Engl J Med. 2020 Jul 16;383(3):252-260. doi: 10.1056/NEJMcp1917030. No abstract available.

  PMID: 32668115 BACKGROUND

• National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995 Dec 14;333(24):1581-7. doi: 10.1056/NEJM199512143332401.

  PMID: 7477192 BACKGROUND

• Kwiatkowski TG, Libman RB, Frankel M, Tilley BC, Morgenstern LB, Lu M, Broderick JP, Lewandowski CA, Marler JR, Levine SR, Brott T. Effects of tissue plasminogen activator for acute ischemic stroke at one year. National Institute of Neurological Disorders and Stroke Recombinant Tissue Plasminogen Activator Stroke Study Group. N Engl J Med. 1999 Jun 10;340(23):1781-7. doi: 10.1056/NEJM199906103402302.

  PMID: 10362821 BACKGROUND

• Ciccone A, Valvassori L, Nichelatti M, Sgoifo A, Ponzio M, Sterzi R, Boccardi E; SYNTHESIS Expansion Investigators. Endovascular treatment for acute ischemic stroke. N Engl J Med. 2013 Mar 7;368(10):904-13. doi: 10.1056/NEJMoa1213701. Epub 2013 Feb 6.

  PMID: 23387822 BACKGROUND

• Albers GW, Marks MP, Kemp S, Christensen S, Tsai JP, Ortega-Gutierrez S, McTaggart RA, Torbey MT, Kim-Tenser M, Leslie-Mazwi T, Sarraj A, Kasner SE, Ansari SA, Yeatts SD, Hamilton S, Mlynash M, Heit JJ, Zaharchuk G, Kim S, Carrozzella J, Palesch YY, Demchuk AM, Bammer R, Lavori PW, Broderick JP, Lansberg MG; DEFUSE 3 Investigators. Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging. N Engl J Med. 2018 Feb 22;378(8):708-718. doi: 10.1056/NEJMoa1713973. Epub 2018 Jan 24.

  PMID: 29364767 BACKGROUND

• Nogueira RG, Jadhav AP, Haussen DC, Bonafe A, Budzik RF, Bhuva P, Yavagal DR, Ribo M, Cognard C, Hanel RA, Sila CA, Hassan AE, Millan M, Levy EI, Mitchell P, Chen M, English JD, Shah QA, Silver FL, Pereira VM, Mehta BP, Baxter BW, Abraham MG, Cardona P, Veznedaroglu E, Hellinger FR, Feng L, Kirmani JF, Lopes DK, Jankowitz BT, Frankel MR, Costalat V, Vora NA, Yoo AJ, Malik AM, Furlan AJ, Rubiera M, Aghaebrahim A, Olivot JM, Tekle WG, Shields R, Graves T, Lewis RJ, Smith WS, Liebeskind DS, Saver JL, Jovin TG; DAWN Trial Investigators. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N Engl J Med. 2018 Jan 4;378(1):11-21. doi: 10.1056/NEJMoa1706442. Epub 2017 Nov 11.

  PMID: 29129157 BACKGROUND

• Campbell BCV, De Silva DA, Macleod MR, Coutts SB, Schwamm LH, Davis SM, Donnan GA. Ischaemic stroke. Nat Rev Dis Primers. 2019 Oct 10;5(1):70. doi: 10.1038/s41572-019-0118-8.

  PMID: 31601801 BACKGROUND

• Potter CA, Vagal AS, Goyal M, Nunez DB, Leslie-Mazwi TM, Lev MH. CT for Treatment Selection in Acute Ischemic Stroke: A Code Stroke Primer. Radiographics. 2019 Oct;39(6):1717-1738. doi: 10.1148/rg.2019190142.

  PMID: 31589578 BACKGROUND

• Ande SR, Grynspan J, Aviv RI, Shankar JJS. Imaging for Predicting Hemorrhagic Transformation of Acute Ischemic Stroke-A Narrative Review. Can Assoc Radiol J. 2022 Feb;73(1):194-202. doi: 10.1177/08465371211018369. Epub 2021 Jun 21.

  PMID: 34154379 BACKGROUND

• Yen P, Cobb A, Shankar JJ. Does computed tomography permeability predict hemorrhagic transformation after ischemic stroke? World J Radiol. 2016 Jun 28;8(6):594-9. doi: 10.4329/wjr.v8.i6.594.

  PMID: 27358687 BACKGROUND

• Dinkel J, Khalilzadeh O, Phan CM, Goenka AH, Yoo AJ, Hirsch JA, Gupta R. Technical limitations of dual-energy CT in neuroradiology: 30-month institutional experience and review of literature. J Neurointerv Surg. 2015 Aug;7(8):596-602. doi: 10.1136/neurintsurg-2014-011241. Epub 2014 Jun 20.

  PMID: 24951287 BACKGROUND

• Gupta R, Phan CM, Leidecker C, Brady TJ, Hirsch JA, Nogueira RG, Yoo AJ. Evaluation of dual-energy CT for differentiating intracerebral hemorrhage from iodinated contrast material staining. Radiology. 2010 Oct;257(1):205-11. doi: 10.1148/radiol.10091806. Epub 2010 Aug 2.

  PMID: 20679449 BACKGROUND

• Tijssen MP, Hofman PA, Stadler AA, van Zwam W, de Graaf R, van Oostenbrugge RJ, Klotz E, Wildberger JE, Postma AA. The role of dual energy CT in differentiating between brain haemorrhage and contrast medium after mechanical revascularisation in acute ischaemic stroke. Eur Radiol. 2014 Apr;24(4):834-40. doi: 10.1007/s00330-013-3073-x. Epub 2013 Nov 21.

  PMID: 24258277 BACKGROUND

• Almqvist H, Holmin S, Mazya MV. Dual energy CT after stroke thrombectomy alters assessment of hemorrhagic complications. Neurology. 2019 Sep 10;93(11):e1068-e1075. doi: 10.1212/WNL.0000000000008093. Epub 2019 Aug 13.

  PMID: 31409735 BACKGROUND

• Yoshizumi T. Dual Energy CT in Clinical Practice. Med Phys. 2011 Nov;38(11):6346. doi: 10.1118/1.3642476.

  PMID: 28525148 BACKGROUND

• Krueger H, Koot J, Hall RE, O'Callaghan C, Bayley M, Corbett D. Prevalence of Individuals Experiencing the Effects of Stroke in Canada: Trends and Projections. Stroke. 2015 Aug;46(8):2226-31. doi: 10.1161/STROKEAHA.115.009616.

  PMID: 26205371 BACKGROUND

• Mangesius S, Janjic T, Steiger R, Haider L, Rehwald R, Knoflach M, Widmann G, Gizewski E, Grams A. Dual-energy computed tomography in acute ischemic stroke: state-of-the-art. Eur Radiol. 2021 Jun;31(6):4138-4147. doi: 10.1007/s00330-020-07543-9. Epub 2020 Dec 14.

  PMID: 33319330 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Cerebral Hemorrhage; Extravasation of Diagnostic and Therapeutic Materials

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: January 9, 2023
• Study Start: October 17, 2023
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: May 1, 2026

Record last verified: 2025-10

Locations

CA (1)