Cone Beam Computed Tomography Following Thrombectomy

Cone Beam Computed Tomography Following Thrombectomy : Identification of Hemorrhage and Distinction From Contrast Accumulation Due to Blood-Brain Barrier Disruption

Sponsors

Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Source Centre Hospitalier Universitaire, Amiens
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.

Overall Status Recruiting
Start Date February 11, 2019
Completion Date September 11, 2020
Primary Completion Date August 11, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Hemorrhage presence up to two days
Secondary Outcome
Measure Time Frame
Number of patients with hemorrhagic transformation 24 hours from symptom onset
Health deterioration 24 hours from symptom onset
Enrollment 66
Condition
Intervention

Intervention Type: Device

Intervention Name: cone beam CT

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.

Arm Group Label: Cone beam CT

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Cyril Chivot, Dr Principal Investigator CHU Amiens
Overall Contact

Last Name: Cyril Chivot, Dr

Phone: (33)32208757538

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: CHU Amiens-Picardie Cyril CHIVOT, Dr (33)322087538 [email protected]
Location Countries

France

Verification Date

March 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Cone beam CT

Type: Experimental

Description: A cone beam CT wll be performed just after thrombectomy on patients with acute ischemic stroke

Acronym Hemathromb
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov