Table 1. Ongoing clinical studies for topical TXA in spinal surgery.
| Ongoing clinical trial | Study design | Condition | Inclusion criteria | Key exclusion criteria | Intervention | Outcome measures |
|---|---|---|---|---|---|---|
| Miyanji and Kilb95; University of British Columbia | RCT, double-blind; target sample size: 80 | Major pediatric spine deformity surgery | 8–21 y old; spinal deformity surgery with OP time > 3 h | Dural tear; coagulopathy; history of thromboembolic events; therapeutic anticoagulation requirement; renal impairment | Topical TXA (dose not mentioned in protocol) versus intravenous TXA (15 mg/kg loading dose at time of incision and continuous infusion of 2 mg/kg/h) | 1. Intra-OP blood loss 2. TXA-related complications (reporting at 6-wk visit) |
| Wood94; Massachusetts General Hospital | RCT, double-blind; target sample size: 80 | Posterior approach thoracolumbar spinal surgery | 18–85 y old; elective multilevel spinal surgery with posterior approach to thoracolumbar spine | Dural tear; coagulopathy; history of thromboembolic events; revision procedure where only instrumentation is removed; renal impairment | Topical TXA (single application of 3 g in 100 mL saline) versus placebo (single application of 100 mL saline) | 1. Change in hemoglobin level (first measurement at pre-OP appointment (1 wk before surgery); patient then followed for hospital stay duration (5 d average) 2. Hospital length of stay in days; no. of transfusions during hospitalization |
| Lehman93; Washington University School of Medicine | RCT, double-blind; target sample size: 252 | Complex combat-related spine trauma surgery | 18–75 y old; thoracic/lumbar spinal column trauma requiring surgical fixation (within 21 d postinjury); elective long segment (>5 fusion levels) posterior spinal fusions | Dural tear; coagulopathy; history of thromboembolic events; therapeutic anticoagulation requirement; use of intravenous TXA during prestudy period; trauma penetrating spinal cord/physiological instability; history of seizure; traumatic brain injury; color vision disturbances; renal impairment | Topical TXA (3 g in solution poured in the surgical field and left in contact for 5 min, before removal of excess solution) versus placebo (saline) | 1. Hemoglobin concentration post-OP; blood transfusion requirements 2. Cost analysis using patient cost info during hospital stay; patient QoL (2-y follow-up); surgical site infection (2-wk follow-up); systemic absorption of locally applied drug; complications (up to 4 d post-OP) |
| Xianming and Jun96; The Military General Hospital of Chengdu, China | Prospective cohort study; target sample size: 150 (50 per group) | Posterior thoracolumbar spinal internal fixation operation | 18–70 y old; elective posterior thoracolumbar spinal internal fixation operation | Coagulopathy; history of thromboembolic events; therapeutic anticoagulation requirement; renal impairment | 3 groups: topical TXA (10 mg/kg) versus intravenous TXA (10 mg/kg) versus placebo (saline) | 1. Intra-OP and post-OP (drainage) blood loss; volume of blood transfusion; hemoglobin; fibrinogen; D-dimer; INR; PT; aPTT |
Abbreviations: aPTT, activated partial thromboplastin time; INR, international normalized ratio; OP, operation; PT, prothrombin time; QoL, quality of life; RCT, randomized controlled trial; TXA, tranexamic acid.