Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery
Blood Loss, Surgical · Blood Loss Anemia
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 4
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Accepted
- Participants
- 83 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
The purpose of this project is to compare the effectiveness of two different but well accepted routes of administration of tranexamic acid in order to reduce blood loss and need for transfusion in patients undergoing lumbar spine surgery. Specifically, this study seeks to identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion.
Read the full description
Spine surgery is associated with large amount of perioperative blood loss. Factors influencing blood loss include surgical technique, operative time, number of vertebral levels arthrodesed, and others. Significant blood loss is associated with complications such as hypotension, end organ damage, or coagulopathy. Blood transfusions can increase risks of infection, blood incompatibility, and allergic reactions. Due to the significant risks and complications associated with blood loss and allogenic transfusions, efforts to identify safe and effective ways of lowering blood loss during spine surgery are crucial. Many methods have been utilized to reduce allogenic blood transfusions, such as autologous blood predonation, antifibrinolytic drugs, acute normovolemic hemodilution, intraoperative blood salvage, and others. Furthermore, the administration of antifibrinolytics, such as tranexamic acid (TXA) and epsilon-aminocaproic acid (EACA), has been shown to reduce bleeding in cardiac, gynecological, urologic and total joint replacement surgeries. There have been many published studies investigating various antifibrinolytic agents such as TXA, EACA, and aprotinin. While aprotinin was shown to increase mortality rate in patients following cardiac surgery, TXA and EACA have not been shown to cause any substantial morbidity or to increase rate of thromboembolic events. Although IV TXA has been shown to be effective in reducing blood loss and transfusions in patients undergoing spine surgery, no studies in the literature have investigated the efficacy of PO TXA in decreasing blood loss and transfusions. The investigators believe that PO TXA will be just as efficacious and more cost-effective in reducing blood loss and transfusion needs in patients undergoing lumbar spine surgery.
The ultimate goal is identifying the most cost-effective protocol to decrease blood loss and need for transfusion. If oral TXA is found to be as efficacious as IV TXA in reducing blood loss and need for transfusion, significant cost savings can be achieved for the patient and the health care system in general.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Adult patients over age 18 and scheduled for open lumbar spine surgery (primary or revision)
- Must be able to swallow tablets
Exclusion Criteria
- Known allergy to TXA
- History of renal failure or kidney transplant
- History of arterial thromboembolic event (eg. myocardial infarction, stroke) within the past year
- Placement of an arterial stent within the past year
- History of blood clots (DVT, PE) within the past year
- Refusal to receive blood products
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
Intravenous Tranexamic Acid
The IV TXA group will receive the standard dosing for our institution of 1 g TXA (diluted in 100 mL normal saline) given as an IV bolus immediately before incision and another 1 g TXA given before closure.
Drug: Tranexamic Acid
Oral Tranexamic Acid
The oral TXA group will receive 1950 mg TXA (3 tablets of 650 mg) approximately 2 hours before incision.
Drug: Tranexamic Acid
Tranexamic Acid DRUG
To identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion in lumbar spine surgery.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Post-operative Change in Hemoglobin Level Between the Two Groups
Time frame: Day of surgery up to 24 hours day after surgery
Not reported in this registry record.
Secondary measures
Post-operative Change of Blood Volume in Milliliters Between the Two Groups
Time frame: 1 day after surgery until 7 days after surgery
The total blood volume change is calculated in milliliters
Number of Participants Transfused Between the Two Groups
Time frame: 1 day after surgery until patient is discharged, up to 7 days
Not reported in this registry record.
Number of Participants Experiencing a Thromboembolic Event Between the Two Groups
Time frame: 1 day after surgery until post operative visit 4 weeks after surgery
Not reported in this registry record.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Henry Ford Health SystemDetroit, Michigan, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- Henry Ford Health System
- Study start
- Feb 15, 2017 Actual
- Primary completion
- Jun 15, 2018 Actual
- Study completion
- Jul 16, 2018 Actual
- First posted
- Jan 31, 2017 Estimated
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
A Randomized Controlled Trial of Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026