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Can donor plasma fix clotting issues in sepsis? new study investigates

NCT ID NCT04580563

Disease control Sponsor: University Hospital, Strasbourg, France Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether a special donor plasma product called OctaplasLG can help people with septic shock who develop blood clotting problems. Sixty participants will receive either OctaplasLG or a placebo (salt water) to see if the treatment improves clotting and outcomes. The goal is to see if this approach is feasible and worth studying further.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OctaplasLG (a standardized donor plasma product)
What this could lead to
If it works, this could point toward a treatment to correct dangerous clotting problems in septic shock patients.
What could go wrong
This is a small feasibility study with only 60 participants, so results may not be conclusive. The treatment may not improve survival or could cause side effects like allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Oct 2020

Finished

Jan 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient with: * a septic shock defined by Sepsis-3 criteria (Singer, JAMA 2016) * and a coagulopathy assessed by decreased platelets (\<150,000/mm3 or \>30% decrease within 24 hours) and an INR\>1.40 (Vincent, Crit Care Med 2013) without other etiology * Randomization within a timeframe of 6 hours after coagulopathy diagnosis * Age strictly over 18 years old * Subject affiliated to a social health insurance * Free and informed consent dated and signed. Exclusion Criteria: * Contraindication to OctaplasLG® * Contraindication to preventive anticoagulation by heparin * Any disorder with a requirement for full anticoagulation on the day of randomization * PT prolongation or thrombocytopenia that is not due to sepsis * History of congenital bleeding disorder predisposing to hemorrhage * Medical condition associated with a hypercoagulable state * Patient moribund on the day of randomization * Do not resuscitate limitation at inclusion in the study * Law protection: guardianship or curatorship * Pregnancy/breastfeeding

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Conditions

The condition(s) this trial relates to.

blood coagulation disease disseminated intravascular coagulation toxic shock syndrome vascular hemostatic disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coagulopathy Disseminated intravascular coagulation Septic shock

Contacts and locations

Locations

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67000, France

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