Cerebral venous thrombosis MedDRA version: 14.0 Level: PT Classification code 10008138 Term: Cerebral venous thrombosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Actilyse
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: ALTEPLASE
CAS Number: 105857236
Concentration unit: mg milligram(s)
Concentration type: rang
Sponsors
IMM - Instituto de Medicina Molecular
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. CVT, confirmed by cerebral angiography (with intra-arte¬rial contrast injection), magnetic resonance venography or computed tomograhy venography. 2. Severe form of CVT with a relatively high chance of poor outcome, as determined by the presence of one of the following disease characteristics: mental status disorder, coma, intracerebral hemorrhage or thrombosis of the deep cerebral venous system. 3. Uncertainty by the treating physician if ET or standard heparin therapy is the optimal therapy for the patient. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Age less than 18 years • Duration from diagnosis to randomization of more than 10 days • Recurrent CVT • Any thrombolytic therapy within last 7 days • Pregnancy (women in the puerperium may be included) • Isolated cavernous sinus thrombosis • Isolated intracranial hypertension (without focal neurological signs, with the exception of papilloedema and 6th cranial nerve palsy) • Contraindication for anti-coagulant or thrombolytic treatment ? documented generalized bleeding disorder ? concurrent thrombocytopenia ( 120 mm Hg) ? known recent (< 3 months) gastrointestinal tract hemorrhage (not including hemorrhage from rectal hemorrhoids) • Any known associated condition (such as terminal cancer) with a poor short term (1 year) prognosis independent of CVT • Clinical and radiological signs of impending transtentorial herniation due to large space-occupying lesions (e.g. large cerebral venous infarcts or hemorrhages) • Recent (< 2 weeks) major surgical procedure (does not include lumbar puncture) or severe cranial trauma • Known allergy against contrast fluid used during endovascular procedures or the throm-bolytic drug used in that particular centre • Previously legally incompetent prior to CVT • No informed consent General notes on exclusion criteria: 1. Intracerebral hemorrhage, hemorrhagic infarction, or subarachnoid hemorrhage as a result of CVT is not an exclusion criterion for this study. 2. Initial treatment with heparin is not an exclusion criterion for this study. Patients who deteriorate while on heparin treatment may be included and randomized if they fulfill the criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the TO-ACT trial is to determine if endovascular thrombolysis improves the functional outcome at 12 months of patients with a severe form of cerebral venous thrombosis.;Secondary Objective: Secondary endpoints 1.Favorable outcome (mRS 0 or 1) at 6 months 2.Rate of death or dependency at 6 and 12 months (mRS 3-6) 3.Outcome on the mRS across the ordinal continuum at 6 and 12 months 4.Recanalisation at 6 months using MR-venography or CT venography Safety endpoints 1.Safety of endovascular thrombolysis as defined by major extracranial hemorrhagic com-plications and symptomatic intracranial hemorrhagic complications within one week fol-lowing the intervention. 2.Mortality at 6 months 3.All serious adverse events ;Primary end point(s): Primary endpoint Outcome on the modified Rankin Scale (mortality included) at 12 months after randomization is considered as the primary study outcome to determine the efficacy of thrombolytic treatment. | — |
Countries
Brazil, France, Netherlands, Portugal, United Kingdom
Contacts
Public ContactProf. José Ferro
IMM - Instituto de Medicina Molecular
Outcome results
None listed