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Assessment of spontaneous intracranial hemorrhage load on Interventional Neuroradiology team for possible enrolment into SAH treatment clinical study
Author(s): ,
L. Levi
Affiliations:
Rambam Medical Center, Haifa, Israel
,
R. Sivan-Hoffmann
Affiliations:
Rambam medical center, Interventional Neuroradiology, Haifa, Israel
,
O. Cohen-Inbar
Affiliations:
Rambam Medical Center, Neurosurgery, Haifa, Israel
,
E. Abergel
Affiliations:
Rambam medical center, Interventional Neuroradiology, Haifa, Israel
G. Sviri
Affiliations:
Rambam Medical Center, Neurosurgery, Haifa, Israel
EANS Academy. Levi L. Oct 21, 2018; 225895; EP1009
Dr. Leon Levi
Dr. Leon Levi
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Abstract
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Background:
While participating in EDGE-Newton-II study for aneurysmal-SAH therapy it was a required to report all SAH admissions in order to assure efficient candidate screening. The inclusion and exclusion protocol parameters led to small group of candidates that should be analyzed also with the general load estimate on Interventional Neuroradiology team (INR) and Neurosurgery during participation.

Methods:
From December 2016 to March 2018, we reviewed daily reports of all admissions with primary diagnosis of any non-traumatic sub-arachnoid hemorrhage (NT-SAH) in our institute which is an academic tertiary center with full service neurosurgery and INR team. The clinical parameters, as well as procedures and outcome (mainly 30-day) served as an estimate of the load on interventional neuroradiology team during the participation in trial.

Results:
Three-hundred patients with NT-SAH were admitted. All underwent diagnostic radiology for evaluation, and 221 out of them were negative. Thirteen of these bleedings underwent craniotomy for evacuation and their mortality was significant lower compared with the non-operative group (8% vs. 37%, P=0.03). Vascular lesion was found in 79 patients (or still suspected after negative angiography). Ruptured aneurysm was the bleeding cause in 42 patients of whom 37 were acutely coiled (within mean 10 hours of presentation). One and 3-month mortality was 8.1% and 10.8% respectively. Of ten patients with EVD and anterior circulation lesion, 6 were screened for the study, and 3 randomized. Study patients underwent 21% of the 130 angio-suite visits until now. Referrals and early analysis led to increase in lost to follow-up rate from 10% in 1-month to 29% in 3-month in 42 patients with aneurysms (p=0.029).

Conclusion:
Screening patients for clinical trials enables the creation of registry and farther evaluation of workloads and institutional achievements. The ratio of 3 dosing per 10 potentials in the EDGE trial was not lower then we predicted.
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