Sinus Thrombosis, Intracranial Clinical Trial
Official title:
Thrombolysis or Anticoagulation for Cerebral Venous Thrombosis (TOACT)
Background: Endovascular thrombolysis, with or without mechanical clot removal (ET), may be
beneficial for a subgroup of patients with cerebral venous sinus thrombosis (CVT), who have
a poor prognosis despite treatment with heparin. Published experience with ET is promising,
but only based on case series and not on controlled trials.
Objective: The main objective of the TO-ACT trial is to determine if ET improves the
functional outcome of patients with a severe form of CVT
Study design: The TO-ACT trial will be designed as a multi-centre, prospective, randomized,
open-label, blinded endpoint (PROBE) trial.
Study population: Patients are eligible if they have a radiologically proven CVT, a high
probability of poor outcome (defined by presence of one or more of the following risk
factors: mental status disorder, coma, intracranial hemorrhagic lesion or thrombosis of the
deep cerebral venous system) and the responsible physician is uncertain if ET or standard
anti-coagulant treatment is better.
Intervention: Patients will be randomized to receive either ET or standard therapy
(therapeutic doses of heparin). ET consists of local application of alteplase or urokinase
within the thrombosed sinuses, and/or mechanical thrombectomy. Glasgow coma score, NIH
stroke scale and relevant laboratory parameters will be assessed at baseline.
Endpoints: The primary endpoint is the modified Rankin scale (mRS) at 12 months. The most
important secondary outcomes are the mRS, mortality and recanalization rate at 6 months.
Major intra- and extracranial hemorrhagic complications within one week following the
intervention are the principal safety outcome. Results will be analyzed according to the
"intention-to-treat" principle. Assessment of study endpoints will be carried out according
to standardized questionnaires by a blinded neurologist or research nurse who is not
involved in the treatment of the patient.
Study size: To detect a 50% relative reduction in mRS≥2 (from 40 to 20%), 164 patients (82
in each treatment arm) have to be included (two-sided alpha, 80% power).
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: Included patients may benefit directly from ET. Complications of ET, most
notably intracranial hemorrhages, constitute the most important risk of the study.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01297348 -
Study Of Lybrel In Relation To Venous Thromboembolism
|
N/A |