Phase 4
Completed N=29
Effectiveness Study of the Drug Tranexamic Acid to Reduce Post-surgery Blood Loss in Spinal Surgery
Lumbar Spinal Stenosis · Thoracic Spinal Stenosis
Source: ClinicalTrials.gov NCT02063035 ↗
Enrolled (actual)
29
Serious AEs
13.8%
Results posted
Jun 2017
Primary outcomePrimary: Change in Hemoglobin Level From Preoperative Appointment to Postoperative Hospital Discharge — -3.2; -4.6 grams per deciliter (g/dL) — p=0.1318
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Hypothesis: Topical application of Tranexamic acid into the surgical wound during spine surgery will decrease the overall blood loss post-operatively. This reduction in blood loss will reduce the need for transfusion. In addition it will also significantly reduce the cost of the surgical procedure.
Specific Aim 1: The goal of this study is to quantitatively assess whether topical application of tranexamic acid placed into the surgical wound during lumbar spine surgery will decrease post-operative blood loss, thus lowering the need for blood transfusions. By reducing the number of transfusions participants can avoid the well-known complications associated with them. The investigators do not plan on measuring serum tranexamic acid levels.
Several meta-analyses and level I studies have shown that intravenous (IV) administration of tranexamic acid is effective in reducing postoperative blood loss and the need for transfusion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin Level From Preoperative Appointment to Postoperative Hospital Discharge |
-3.2; -4.6 | 0.1318 |
| SECONDARY Blood Loss Volume Following Surgery |
534; 530 | — |
| SECONDARY Hospital Length of Stay in Days |
5; 6 | — |
| SECONDARY Post-operative Blood Transfusions During Hospitalization |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 18-85 years, both male and female
- Undergoing elective multi-level spinal surgery with a posterior approach to the thoracolumbar spine.
- Negative pregnancy test
Exclusion Criteria
- Allergy to tranexamic acid
- Preoperative anemia (Hemoglobin 1.4, or Partial Thromboplastin Time > 1.5 times normal)
- History of deep vein thrombosis, stroke, or pulmonary embolism
- Pregnant or breast feeding
- Liver function tests 2 times the upper limit of normal, and those with creatine greater than 1.6 milligrams per deciliter (mg/dL)
- Infection
- Revision procedure in which the only procedure is removing instrumentation
- Renal impairment
- Dural tear
Data sourced from ClinicalTrials.gov (NCT02063035). 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.