BACKGROUND: Ischaemic stroke is the second cause of death and the first cause of disability in
Europe. Nowadays, the only available pharmacological treatment for acute ischaemic stroke is
recombinant tissue plasminogen activator (rt-PA). However, it only achieves the reperfusion of
the occluded vessel in 50% of the patients. Moreover, only 5-10% of the patients can receive
this treatment due to its numerous contraindications. One of the possible complications of the
treatment with rt-PA is the haemorrhagic transformation of the stroke. Although it only occurs
in 2-7% of the patients, it worsens the recovery and prognosis of the patient. Another fact that
might negatively influence in the outcome of the patient is alpha-1 antitrypsin (AAT) deficiency.
AAT is the main antiprotease in bloodstream and its activity is crucial to maintain the balance
between proteases and antiproteases in order to limit the proteolytic effect of proteases in
tissues, for instance in blood-brain barrier (BBB). Thus, AAT deficiency might be related to BBB
disruption, neuronal cell death and an increase and exacerbation of the inflammatory response
after an ischaemic stroke, worsening the outcome of the patient.
OBJECTIVE: To analyse AAT levels in blood samples of patients with acute ischaemic stroke
treated with rt-PA, at admission, 2, 6, 24 and 72 hours, and correlate these levels with the
functional outcome of the patient at 3 months (modified RANKIN scale).
DESIGN AND PARTICIPANTS: The study will consist in a prospective cohort study including
consecutive patients suffering from acute ischaemic stroke (independently of the aetiology of
the stroke) treated with rt-PA in the Neurology Department of Hospital Dr. Josep Trueta,
between 1 June 2020 and 31 November 2022.
METHODS: 5 blood samples will be extracted in the acute phase of stroke (at admission, 2, 6, 24
and 72 hours). Patients will be divided into two groups according to AAT levels at admission:
normal levels of AAT (31-2 g/L) versus low levels of AAT (<1 g/L). 196 patients will be required
in each group. 3 months after the stroke, the prognosis of the patient will be evaluated using
the modified RANKIN scale. AAT levels in the acute phase of the stroke will be compared with
levels at 3 months. Infarct volume and the presence of haemorrhagic transformation will be
assessed with computed tomography (CT) scan at 24 hours of the stroke, and these variables
will be correlated with AAT levels in the acute phase
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