CompletedPhase 2

TXA in Spinal Fusion

United States123 participantsStarted 2020-08-01

Plain-language summary

Tranexamic acid and placebo will be given during surgery to patients who have elected to undergo lumber interbody fusion on 2 or more levels. Information regarding blood loss, transfusions needed, postoperative cognitive status (including delirium), postoperative markers of systemic inflammation and duration of hospital stay will be collected.

Who can participate

Age range18 Years – 90 Years

SexALL

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 18-90 years
✓. American Spinal Injury Association (ASA) Impairment Scale anesthesia risk of I to IV
✓. Patients undergoing 2 or more levels of posterior lumbar interbody fusion for DDD. This includes PLIF or TLIF.
✓. Patients have failed conservative management, which include physical therapy (PT) or occupational therapy (OT) and/or injections.

Exclusion criteria

✕. ASA class V
✕. Patient unable to consent
✕. Patient with chronic kidney disease stage III or above: baseline plasma creatinine\>1.5mg/dL
✕. Patient with known liver failure
✕. Patients on anticoagulation or dual antiplatelets (presence of vascular stents).
✕. Patients with artificial valves.
✕. Patients with allergy to TXA
✕. Patients with platelet count \< 150 000,

What they're measuring

Transfusion

Timeframe: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported

Blood Loss

Timeframe: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported

Delirium Occurrence

Timeframe: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported

Trial details

NCT IDNCT04272606

SponsorCatherine R. Olinger

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-12

Results submitted2024-01-31

View on ClinicalTrials.gov More Degenerative Disc Disease trials

Plain-language summary

Who can participate

Age range18 Years – 90 Years

SexALL

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 18-90 years
✓. American Spinal Injury Association (ASA) Impairment Scale anesthesia risk of I to IV
✓. Patients undergoing 2 or more levels of posterior lumbar interbody fusion for DDD. This includes PLIF or TLIF.
✓. Patients have failed conservative management, which include physical therapy (PT) or occupational therapy (OT) and/or injections.

Exclusion criteria

✕. ASA class V
✕. Patient unable to consent
✕. Patient with chronic kidney disease stage III or above: baseline plasma creatinine\>1.5mg/dL
✕. Patient with known liver failure
✕. Patients on anticoagulation or dual antiplatelets (presence of vascular stents).
✕. Patients with artificial valves.
✕. Patients with allergy to TXA
✕. Patients with platelet count \< 150 000,

What they're measuring

Transfusion

Timeframe: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported

Blood Loss

Timeframe: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported

Delirium Occurrence

Timeframe: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported