Implications for blinding in clinical trials with THC-containing cannabinoids based on the CANNA-TICS trial.

Randomized double-blind placebo-controlled trials (RCTs) are regarded as the gold standard for clinical trials. While there are established standards to avoid unblinding, in RCTs using tetrahydrocannabinol (THC) containing cannabinoids, however, accidental unblinding and intentional self-unbinding must be considered as a particular issue, since THC tests are widely available. To investigate unblinding rates in an RCT using a THC-containing cannabinoid, we re-contacted 54 out of 97 participants of the CANNA-TICS trial who had participated in our study center in Hannover.

Thromboembolic characteristics and role of anticoagulation in long-standing Fontan circulation.

Introduction: The risk of thromboembolism increases with duration of Fontan circulation. Preventive drug strategies are still discussed controversially. We aimed to characterize clinical relevant thromboembolism in long-standing Fontan circulation and to analyse the protective effect of Acetylsalicylic acid (ASA) and Vitamin K Antagonists (VKA).

Prediction of heart failure and death in an adult population of Fontan patients.

Background: Late Fontan survivors are at high risk to experience heart failure and death. Therefore, the current study sought to investigate the role of non-invasive diagnostics as prognostic markers for failure of the systemic ventricle following Fontan procedure.

Methods: This monocentric, longitudinal observational study included 60 patients with a median age of 24.