Diagnostic and treatment recommendations from the FACME ad-hoc expert working group on the management of cerebral venous sinus thrombosis associated with COVID-19 vaccination

Abstract

Introduction Cases of cerebral venous sinus thrombosis have been reported in individuals vaccinated against COVID-19 with non-replicating adenoviral vector vaccines. We issue our recommendations on the diagnosis and management of patients presenting this complication. Methods The multidisciplinary working group, led by the Spanish Federation of Medical and Scientific Associations (FACME) and including representatives of several scientific societies, reviewed the available evidence from the literature and reports of the European Medicines Agency. We establish a definition for suspected cases and issue diagnostic and treatment recommendations regarding vaccine-induced immune thrombotic thrombocytopaenia. Results We define suspected cases as those cases of cerebral venous sinus thrombosis occurring between 3 and 21 days after the administration of non-replicating adenoviral vector vaccines, in patients with a platelet count below 150 000/μL or presenting a decrease of 50% with respect to the previous value. Findings suggestive of vaccine-induced immune thrombotic thrombocytopaenia include the presence of antibodies to platelet factor 4, D-dimer levels 4 times greater than the upper limit of normal, and unexplained thrombosis. The recommended treatment includes intravenous administration of non-specific human immunoglobulin or alternatively plasmapheresis, avoiding the use of heparin, instead employing argatroban, bivalirudin, fondaparinux, rivaroxaban, or apixaban for anticoagulation, and avoiding platelet transfusion. Conclusions Non-replicating adenoviral vector vaccines may be associated with cerebral venous sinus thrombosis with thrombocytopaenia; it is important to treat the dysimmune phenomenon and the cerebral venous sinus thrombosis.

Delayed headache after COVID-19 vaccination: a red flag for vaccine induced cerebral venous thrombosis

“…In most of the reported cases symptoms started 1 week after immunization. Headache was not described in detail in most cases, but in the few it was, it was reported as severe, progressive and treatment-resistant, all of them well-known red flags [ 12].…”

“…Headache is the most frequent symptom in CVT, and it may occur isolated or accompanied by other symptoms [9][10][11]. As in other secondary headache disorders, CVT may be recognized by the presence of red flags [11,12]. Herein we highlight a potential novel red flag based on the available scientific data that may help clinicians to properly identify cases of CVT following non-replicant adenovirus vector-based COVID-19 vaccines.…”