Cone Beam Computed Tomography Following Thrombectomy

Stroke Clinical Trial

— Hemathromb  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03869567
• Other study ID #: PI2018_843_0027
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 11, 2019
• Est. completion date: June 25, 2023

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: June 25, 2023
• Est. primary completion date: August 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Stroke

Intervention

Device:
• cone beam CT
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.

Locations

Country	Name	City	State
France	CHU Amiens-Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemorrhage presence	hemorrhage presence or not is determined with cone beam and scanner images	up to two days
Secondary	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.	24 hours from symptom onset
Secondary	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.	24 hours from symptom onset