Cone Beam Computed Tomography Following Thrombectomy (Hemathromb)
Primary Purpose
Stroke, Hemorrhage
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cone beam CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Stroke focused on measuring thrombectomy, flat panel Computed tomography, cone beam computed tomography, hemorrhage, stroke, dual energy computed tomography
Eligibility Criteria
Inclusion Criteria:
- all patients with cerebral thrombectomy
- Adults
- Patients able to express consent
- Signed written informed consent form
- Covered by national health insurance
Exclusion Criteria:
- minors
- pregnancy or beast feeding
- patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
- obstruction to participate
- non covered by national health insurance
Sites / Locations
- CHU Amiens-Picardie
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cone beam CT
Arm Description
A cone beam CT wll be performed just after thrombectomy on patients with acute ischemic stroke
Outcomes
Primary Outcome Measures
Hemorrhage presence
hemorrhage presence or not is determined with cone beam and scanner images
Secondary Outcome Measures
Number of patients with hemorrhagic transformation
Any type of parenchyma hemorrhage according to ECASS II criteria (European Cooperative Acute Stroke Study 2). Scores are HI1, HI2, PH1 or PH2. HI1 = small petechia around stroke area. HI2 = confluent petechia in the stroke area. PH1 = Hematoma with less than 30% stroke weight. PH2 = Hematoma with more than 30% stroke weight.
Health deterioration
Any deterioration in NIHSS score (NIHSS : National Institute of Heath Stroke ) or death combined with intracerebral hemorrhage. Scale of NIHSS score : 1 to 42. Minimum score : 1. Maximum score : 42. 1-4 : minor stroke. 5-15 : mild stroke. 15-20 : acute stroke. More than 20 : major stroke.
Full Information
NCT ID
NCT03869567
First Posted
February 21, 2019
Last Updated
May 9, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT03869567
Brief Title
Cone Beam Computed Tomography Following Thrombectomy
Acronym
Hemathromb
Official Title
Cone Beam Computed Tomography Following Thrombectomy : Identification of Hemorrhage and Distinction From Contrast Accumulation Due to Blood-Brain Barrier Disruption
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 11, 2019 (Actual)
Primary Completion Date
August 11, 2020 (Actual)
Study Completion Date
June 25, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cerebral haemorrhages following reperfusion treatments involve not only rupture of the blood-brain barrier, but also direct damage to vessels related to the equipment used and secondary toxicity to thrombolytics. The rupture of the blood-brain barrier which results from ischemia / reperfusion is responsible for stagnation of the contrast product on the exams performed after thrombectomy. It is difficult to distinguish hyperdensities related to the stagnation of contrast product and Hemorrhage on a conventional scanner. The reference imaging is the double energy scanner performed at the thrombectomy outlet. But no study directly compared the results of the flat panel with the cone beam CT performed in immediate post-thrombectomy. The investigators propose a direct comparison of the cone beam CT with the dual energy CT performed at the exit of thrombectomy.
Detailed Description
Until December 2014, intravenous thrombolysis was the only reperfusion therapy proven to be effective within 4 hours of a cerebral infarction and several studies showed a clear functional benefit of thrombectomy in combination with thrombolysis in the first six hours of proximal arterial occlusion. Cerebral haemorrhages following reperfusion treatments involve not only rupture of the blood-brain barrier, but also direct damage to vessels related to the equipment used and secondary toxicity to thrombolytics. The rupture of the blood-brain barrier which results from ischemia / reperfusion is responsible for stagnation of the contrast product on the exams performed after thrombectomy, but it is difficult to distinguish hyperdensities related to the stagnation of contrast product and Hemorrhage on a conventional scanner. Several techniques are available to evaluate the hyperdensities post endovascular cerebral reperfusion including: the dual energy ct, the flat panel CT performed in the angiography room and the conventional scanner. The Cone beam CT is a relevant exam because it is performed in the angiography room and does not require transporting the patient who can be agitated or intubated until the scanner. The reference imaging is the double energy scanner performed at the thrombectomy outlet. Some studies have shown an excellent negative predictive value of the flat panel CT to eliminate haemorrhage in post-thrombectomy but no study directly compared the results of the flat panel with the CT performed in immediate post-thrombectomy and even less with the double energy scanner, it is therefore difficult to assert the sensitivity and exact specificity of this exam to detect and distinguish haemorrhage from contrast stagnation. The investigators propose a direct comparison of the cone beam CT with the dual energy CT performed at the exit of thrombectomy.
Method: consecutive patients presenting acute ischemic stroke candidates to thrombectomy will be enrolled in one hospital center. A cone beam Ct will be performed at the end of the procedure as well as a dual energy CT and finally a CT 24 h after the thrombectomy. Predictive factors of hemorrhage transformation such blood barrier disruption will be studied secondarily.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemorrhage
Keywords
thrombectomy, flat panel Computed tomography, cone beam computed tomography, hemorrhage, stroke, dual energy computed tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cone beam CT
Arm Type
Experimental
Arm Description
A cone beam CT wll be performed just after thrombectomy on patients with acute ischemic stroke
Intervention Type
Device
Intervention Name(s)
cone beam CT
Intervention Description
Just after thrombectomy, a cone beam CT will be done, while patient is on angiography table, in order to determine if hemorrhage image is due to contrast accumulation or blood-brain barrier disruption.
Primary Outcome Measure Information:
Title
Hemorrhage presence
Description
hemorrhage presence or not is determined with cone beam and scanner images
Time Frame
up to two days
Secondary Outcome Measure Information:
Title
Number of patients with hemorrhagic transformation
Description
Any type of parenchyma hemorrhage according to ECASS II criteria (European Cooperative Acute Stroke Study 2). Scores are HI1, HI2, PH1 or PH2. HI1 = small petechia around stroke area. HI2 = confluent petechia in the stroke area. PH1 = Hematoma with less than 30% stroke weight. PH2 = Hematoma with more than 30% stroke weight.
Time Frame
24 hours from symptom onset
Title
Health deterioration
Description
Any deterioration in NIHSS score (NIHSS : National Institute of Heath Stroke ) or death combined with intracerebral hemorrhage. Scale of NIHSS score : 1 to 42. Minimum score : 1. Maximum score : 42. 1-4 : minor stroke. 5-15 : mild stroke. 15-20 : acute stroke. More than 20 : major stroke.
Time Frame
24 hours from symptom onset
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all patients with cerebral thrombectomy
Adults
Patients able to express consent
Signed written informed consent form
Covered by national health insurance
Exclusion Criteria:
minors
pregnancy or beast feeding
patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
obstruction to participate
non covered by national health insurance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cyril Chivot, Dr
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens-Picardie
City
Amiens
ZIP/Postal Code
80054
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Cone Beam Computed Tomography Following Thrombectomy
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