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Efficacy of Sivelestat in Patients with Septic Coagulopathy: A Phase IIb Randomized Controlled Trial

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on patients who have developed Septic Coagulopathy, a condition where a severe infection causes the blood’s ability to clot and dissolve clots to become abnormal. The treatment being tested is an intravenous infusion of the drug Sivelestat, which is intended to help restore the balance of clot‑breaking activity in the bloodstream. For comparison, some participants will receive a standard saline solution, which serves as a placebo.

The purpose of the trial is to determine whether Sivelestat can improve clot‑breaking function compared with placebo. Participants will be randomly assigned to receive either the study drug or the placebo for several days while they are in the hospital. Blood samples will be taken before treatment and at several time points during the first week to measure levels of proteins such as plasminogen, which helps dissolve clots. Doctors will also monitor standard health indicators, organ function, and any side effects throughout the hospital stay and during follow‑up visits up to three months after treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and start of infusion

    After joining the study, you are assigned by the study staff to receive either the test medication elaspol (which contains sivelestat) or the placebo solution sodium chloride.

    The assignment is done randomly, so you do not know which one you will receive.

  2. Step 2

    Administration of study medication

    The assigned medication is given by intravenous (iv) infusion, which means it is delivered directly into a vein.

    If you receive elaspol, the dose is 0.2 mg/kg/h (milligrams per kilogram of body weight per hour) of sivelestat, mixed into a solution and infused continuously.

    If you receive the placebo, the infusion contains 50 ml of a sodium chloride solution.

    The infusion is started on day 1 and continues for at least 24 hours, with the exact duration determined by the study protocol.

  3. Step 3

    Daily laboratory assessments

    Blood samples are taken before the first infusion (day 1 baseline) and then on day 2, day 3, day 4, and day 7.

    The tests include measurements of coagulation and fibrinolysis markers such as plasma plasminogen, pt, d‑dimer, antithrombin, and others, as well as a complete blood count (cbc).

    These results are used to evaluate the effect of the medication on your blood‑clotting system.

  4. Step 4

    Safety monitoring

    Throughout the infusion period and the hospital stay, study staff systematically record any adverse events (ae), which are any unwanted medical occurrences.

    Serious adverse events (sae), especially bleeding or clotting problems, are given special attention.

    Your vital signs and organ‑function indicators are checked regularly.

  5. Step 5

    Clinical assessments up to day 28

    Additional clinical evaluations are performed up to day 28, including the sepsis support index (ssi), a penalized ssi, and the sofa score, which measures the severity of organ failure.

    The sofa score is recorded on day 1, day 2, day 3, day 4, and day 7.

  6. Step 6

    Extended follow‑up to day 90

    The study continues to collect information on your status up to day 90.

    Outcomes recorded include the number of days free from mechanical ventilation, vasopressor support, intensive care unit (icu) stay, and overall hospitalization.

    Mortality (whether you are alive) is noted at day 7, day 28, and day 90.

Who can join the trial?

8 criteria

  • Age between 18 and 85 years.
  • Currently in an intensive care unit with septic shock, which is a serious infection that causes dangerously low blood pressure and organ problems.
  • The septic shock must meet the Sepsis‑3 criteria: the patient needs medication called a vasopressor to keep the average blood pressure (mean arterial pressure) at 65 mmHg or higher, and a blood test shows a lactate level higher than 2 mmol/L (a sign that the body is not getting enough oxygen).
  • Must have a blood‑clotting problem called coagulopathy, identified by a SIC score (Sepsis‑Induced Coagulopathy score) of 4 points or more.
  • Enrollment in the study must occur within 12 hours after the coagulopathy is diagnosed.
  • Must be covered by a national health‑insurance system.
  • Must give written informed consent (a signed agreement to join the study), either by the patient, by a legal representative if the patient cannot sign, or through an emergency procedure when no representative is available.
  • Women of child‑bearing age must have a negative pregnancy test before joining.

Who cannot join the trial?

10 criteria

  • History of a hypersensitivity reaction (allergic response) to the study drug Sivelestat.
  • History of heparin‑induced thrombocytopenia (HIT), a condition where a blood thinner called heparin causes a low platelet count.
  • Body weight greater than 100 kg (about 220 pounds).
  • Severe chronic liver disease classified as Child‑Pugh C, which is the most advanced stage of liver damage.
  • Any reason you cannot use unfractionated heparin, a common blood‑thinning medication.
  • Being moribund (extremely ill and near death) on the day of randomisation.
  • Having chosen to limit or stop active medical treatments at the time of study inclusion.
  • Being under legal protection such as guardianship, curatorship, or other legal safeguard.
  • Being pregnant (positive pregnancy test) or breastfeeding.
  • Already participating in another interventional drug clinical trial.
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Investigated drugs

Sivelestat is an intravenous medication that works by blocking an enzyme called neutrophil elastase, which can cause inflammation and damage in the lungs and blood vessels during severe infections. In this trial, it is being tested to see if it can help restore the body’s ability to break down blood clots (fibrinolysis) in patients who have septic shock and abnormal blood clotting. By reducing inflammation and improving clot breakdown, the drug may support better organ function and recovery in these very sick patients.

What is already known about the treatment

  • SODIUM CHLORIDE

    It is given intravenously as a sterile saline solution (50 ml) and is used to replace lost fluids and electrolytes. The product is a well‑known, widely used medical fluid that is listed in standard pharmacopeias and has a long history of safe use. Its main use is to restore fluid balance in patients who need volume replacement or electrolyte correction. It works by providing sodium and chloride ions that expand the blood volume and help maintain normal blood chemistry; it is classified as an isotonic crystalloid electrolyte solution.

  • ELASPOL

    Elaspol is supplied as a powder that is reconstituted for intravenous infusion at a dose of 0.2 mg per kg per hour. Sivelestat, the active ingredient, is an approved drug in Japan for treating acute lung injury and is being studied in other countries for septic coagulopathy. It is mainly intended to reduce inflammation and improve blood clot breakdown in severe infection. The drug works by blocking the enzyme neutrophil elastase, which protects tissues from damage caused by excessive inflammation; it belongs to the class of protease inhibitors, specifically neutrophil elastase inhibitors.

Investigated diseases

Septic coagulopathy - Septic coagulopathy is a condition where the blood’s clotting system becomes abnormal during a severe infection. It starts when infection triggers inflammation that interferes with normal clotting proteins. As the condition progresses, patients may develop either excessive clot formation or bleeding tendencies. The imbalance can affect many organs as blood flow is altered. Monitoring of clotting tests helps to see how the condition changes over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523397-16-00Protocol codeHUS n°9415Estimated enrolment120 patientsSponsorLes Hopitaux Universitaires De Strasbourg

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