Phase 2
Completed N=86
TXA in Spinal Fusion
Source: ClinicalTrials.gov NCT04272606 ↗Enrolled (actual)
86
Serious AEs
2.4%
Results posted
May 2024
Primary outcomePrimary: Transfusion — 7; 6; 9; 8 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Transfusion |
7; 6; 9; 8; 10; 10 | — |
| PRIMARY Blood Loss |
167; 110; 128; 207; 305; 333 | — |
| PRIMARY Delirium Occurrence |
7; 11 | — |
| SECONDARY Delirium Severity |
1.10; 1.00 | — |
| SECONDARY Change in Interleukin-6 Concentration. |
25.7; 10.6 | — |
| SECONDARY Length of Postoperative Stay Prior to Discharge |
3; 3 | — |
Eligibility Criteria
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 15s
- Patients with Activated Partial Thromboplastin Time (APPT) >38s
- History of stroke or (an) unprovoked thromboembolic event(s).
- History of intracranial bleeding,
- Pregnancy
- known defective color vision
- history of venous or arterial thromboembolism or active thromboembolic disease
- Patients with severe pulmonary or cardiac disease.
- Patients who refuse transfusion of blood products
- Patients with chronic anemia with Hg<8
- Patients undergoing lumbar fusion for disease other than DDD (neoplasm)
- Patients undergoing lumbar fusion by anterior or lateral approach.
- Minimally invasive TLIF are excluded.
- Emergent cases.
- Women on hormonal contraception
- Retinal vein or artery occlusion
- Hypercoagulability
- Seizure disorder
- Current use of tretinoin
- Current use of chlorpromazine
- Breast feeding
Data sourced from ClinicalTrials.gov (NCT04272606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.