In short
Clinical trials investigating APROTININ are studying whether it can improve outcomes in patients with acute respiratory distress syndrome. The trial data also show related surgical research, but APROTININ is the main focus here. These studies aim to evaluate efficacy and clinical outcomes in specific patient groups.
Key points
- Clinical trials investigating APROTININ are focused on patients with acute respiratory distress syndrome, especially those with moderate or severe disease. The main APROTININ study is a Phase 3 interventional trial and compares inhaled APROTININ with saline solution. Its main goal is to measure ventilator-free days, which shows how long patients can breathe without a machine. The data also include a separate Phase 3 surgical trial in cancer patients, but that study investigates a fibrin adhesive rather than APROTININ. Both studies are authorised and are designed to measure clinical outcomes in specific patient groups.
Trial overview
The trial data include one study that investigates APROTININ and one separate study that does not use APROTININ. The APROTININ trial is a Phase 3 interventional study in patients with acute respiratory distress syndrome, and it is authorised.
The other study in the source data is also authorised and Phase 3, but it looks at a fibrin adhesive in surgery for cancer, not APROTININ.
APROTININ in acute respiratory distress syndrome
This APROTININ trial is called a clinical trial with APROTININ in the treatment of acute respiratory distress syndrome. It is designed to test whether inhaled APROTININ can improve clinical outcomes in patients with moderate or severe ARDS.
The study compares inhaled APROTININ 200 KIU/mL with saline solution. Saline solution is a simple salt-water solution and is used here as the comparison treatment.
The trial is Phase 3, which means it is being tested in a larger group of patients to better understand how well it works. The planned enrollment is 156 patients.
The main endpoint is ventilator-free days, also called DLVI in the source data. A patient is counted as ventilator-free after two straight calendar days without assisted breathing. The study also plans an exploratory analysis at day 90, which means the researchers will take an extra look at the results later on.
The brief summary says the main objective is to show that APROTININ improves the clinical course and lowers the need for mechanical ventilation in patients with moderate or severe ARDS.
Other trial in the source data
The second trial is a randomized, multicenter Phase 3 study in people having total gastrectomy for cancer. Its goal is to see whether a fibrin-based adhesive can reduce esophagojejunal anastomosis dehiscence, which means a breakdown or opening of the surgical connection after the operation.
This study includes 240 participants and measures dehiscence within the first seven days after surgery using clinical and/or radiological findings and the Csendes classification. Although this trial is part of the same source set, it does not investigate APROTININ.
Key trial terms
Authorised means the study has been approved to start.
Interventional study means the researchers give a treatment and then measure what happens.
Primary outcome or primary endpoint means the main result used to judge the study.
Exploratory analysis means an extra analysis done to look for additional patterns or effects.
Mechanical ventilation means breathing support from a machine, and ventilator-free days measures time without that support.
Csendes classification is a way to grade the severity of a surgical leak or opening after surgery.