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APROTININ

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.

Table of Contents

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.[1]

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.[2]

APROTININ in acute respiratory distress syndrome

This APROTININ trial is called a clinical trial with APROTININ in the treatment of acute respiratory distress syndrome.[1] It is designed to test whether inhaled APROTININ can improve clinical outcomes in patients with moderate or severe ARDS.[1]

The study compares inhaled APROTININ 200 KIU/mL with saline solution.[1] Saline solution is a simple salt-water solution and is used here as the comparison treatment.[1]

The trial is Phase 3, which means it is being tested in a larger group of patients to better understand how well it works.[1] The planned enrollment is 156 patients.[1]

The main endpoint is ventilator-free days, also called DLVI in the source data.[1] A patient is counted as ventilator-free after two straight calendar days without assisted breathing.[1] The study also plans an exploratory analysis at day 90, which means the researchers will take an extra look at the results later on.[1]

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.[1]

Other trial in the source data

The second trial is a randomized, multicenter Phase 3 study in people having total gastrectomy for cancer.[2] 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.[2]

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.[2] Although this trial is part of the same source set, it does not investigate APROTININ.[2]

Key trial terms

Authorised means the study has been approved to start.[1][2]

Interventional study means the researchers give a treatment and then measure what happens.[1][2]

Primary outcome or primary endpoint means the main result used to judge the study.[1][2]

Exploratory analysis means an extra analysis done to look for additional patterns or effects.[1]

Mechanical ventilation means breathing support from a machine, and ventilator-free days measures time without that support.[1]

Csendes classification is a way to grade the severity of a surgical leak or opening after surgery.[2]

Trial ID Phase Condition studied Status Enrollment
2025-520826-39-00 Phase 3 Acute respiratory distress syndrome Authorised 156
2024-519529-40-00 Phase 3 Esophagojejunal anastomosis dehiscence in total gastrectomies for cancer Authorised 240

FAQ

  • What is being studied in APROTININ clinical trials? The trials are studying whether APROTININ can improve outcomes in patients with acute respiratory distress syndrome. The main goal is to see if it helps patients spend more days without mechanical ventilation.
  • Who can take part in the APROTININ trial? The APROTININ trial is for patients with moderate or severe acute respiratory distress syndrome. The study data do not list other participation details.
  • What phase is the APROTININ trial? The APROTININ trial is a Phase 3 study. This means it is testing the treatment in a larger group of patients to assess how well it works.
  • What outcome is measured in the APROTININ trial? The main outcome is ventilator-free days. A patient is counted as ventilator-free after two straight calendar days without assisted breathing.
  • Are there other clinical trials in the data set? Yes. One other trial studies a fibrin adhesive in people having total gastrectomy for cancer. That study is not about APROTININ, but it appears in the same trial data.

Ongoing Clinical Trials on APROTININ

  • Study of inhaled aprotinin for treatment of moderate to severe acute respiratory distress syndrome

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on Fibrin Adhesive to Prevent Leaks After Stomach Cancer Surgery Using Aprotinin, Human Fibrinogen, and Calcium Chloride Dihydrate in Patients Undergoing Total Gastrectomy

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Acute respiratory distress syndrome: A serious lung condition that makes it hard to get enough oxygen into the body.
  • Moderate or severe ARDS: A more serious form of acute respiratory distress syndrome, used to describe how badly the lungs are affected.
  • Mechanical ventilation: A machine that helps a person breathe when they cannot breathe well on their own.
  • Ventilator-free days: The number of days a patient stays alive and does not need a breathing machine.
  • Unassisted ventilation: Breathing without help from a machine.
  • Primary endpoint: The main result the researchers use to judge whether the treatment works.
  • Exploratory analysis: An extra look at the data to find possible patterns or effects that are not the main goal of the study.
  • Phase 3: A later stage of clinical testing in a larger group of patients to check how well a treatment works.
  • Interventional study: A study where researchers give a treatment or compare treatments to see what happens.
  • Authorised: The study has been approved to start.
  • Esophagojejunal anastomosis dehiscence: A separation or opening of a surgical connection between the esophagus and the jejunum after surgery.

References

  1. https://clinicaltrials.gov/study/2025-520826-39-00
  2. https://clinicaltrials.gov/study/2024-519529-40-00