Study of Protection And Repair of Endothelial-glycocalyx in Sepsis (SPARES)

Beth Israel Lahey Health

Status and phase: Not yet enrolling; Phase 2

Conditions: Sepsis

Treatments: Biological: Fresh Frozen Plasma (blood product); Drug: MVI and lactated ringers

Study type: Interventional

Funder types: Other

Identifiers

NCT07160426

SPARES Pilot

Details and patient eligibility

About

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.

Full 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 continuous to maintain blinding). Primary biologic readout is change in syndecan-1 (glycocalyx degradation) with additional endothelial activation and inflammation markers; key clinical endpoints include mortality and organ failure-free days. Target enrollment is 45 adults with sepsis (SOFA ≥2) within ICU or ED settings.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups, including a placebo group

Experimental: FFP Bolus

Experimental group

Description:

Two-unit initial FFP bolus, then one unit every 12 hours for 48 hours (total 5 units).

Treatment:

Biological: Fresh Frozen Plasma (blood product)

Experimental: FFP Continuous Infusion

Experimental group

Description:

5 units FFP infused continuously at \~42 mL/hr over 48 hours.

Treatment:

Biological: Fresh Frozen Plasma (blood product)

Placebo Comparator: Lactated Ringer's + Multivitamins

Placebo Comparator group

Description:

Placebo given as either (a) 500 mL LR bolus, then 250 mL q12h for 48h (total 1,250 mL), or (b) 500 mL over 12h, repeated to total 2,000 mL over 48h; prepared by pharmacy to match plasma appearance.

Treatment:

Drug: MVI and lactated ringers