Status:
NOT_YET_RECRUITING
Study of Protection And Repair of Endothelial-glycocalyx in Sepsis
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
University of Colorado Health
Conditions:
Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Multicenter, blinded, placebo-controlled randomized pilot trial comparing: (1) FFP bolus regimen; (2) FFP continuous infusion; and (3) placebo (LR with multivitamins, administered as bolus or continuo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT07160426
Start Date
November 1 2025
End Date
October 1 2027
Last Update
September 8 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.