Study of Protection And Repair of Endothelial-glycocalyx in Sepsis (SPARES) (NCT07160426) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study of Protection And Repair of Endothelial-glycocalyx in Sepsis (SPARES)
45 participantsStarted 2026-07-01
Plain-language summary
Sepsis damages the blood vessel lining and its protective "glycocalyx," contributing to organ failure and death. This pilot, randomized, blinded study will test whether giving fresh frozen plasma (FFP)-either as intermittent boluses or as a continuous infusion-protects or repairs the glycocalyx compared with look-alike placebo fluid (lactated Ringer's with multivitamins), and whether this leads to better clinical outcomes. We will measure blood and urine biomarkers of glycocalyx injury and track organ support needs, ICU/hospital-free days, and survival through 28-90 days.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years
* Confirmed or suspected infection (pathogen detected or antimicrobial administered)
* SOFA score ≥2
* ICU patient or ED patient with anticipated ICU admission
Exclusion Criteria:
* Unable to randomize within 24h of meeting inclusion criteria
* Current hospitalization \>2 days
* Decision to withhold life-sustaining treatment (exception for DNR only)
* Moribund; not expected to survive 24h
* Life expectancy \<28 days from non-sepsis condition
* Any condition where participation isn't in the patient's best interest or limits assessments
* Prisoner
* Pregnancy
* Concurrent interventional trial with overlapping treatments/outcomes
* Inability to obtain patient/LAR consent
* History of Transfusion Related Acute Lung Injury (TRALI) or Transfusion Associated Circulatory Overload (TACO)
* End Stage Renal Disease
* Chronic tracheostomy with ventilator use
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.