Blood Loss, SurgicalPhase 4NCT03037515
Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery
A Phase 4 study testing Tranexamic Acid in people with Blood Loss, Surgical and Blood Loss Anemia, run by Henry Ford Health System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Loss, Surgical, Blood Loss Anemia
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2017to 16 Jul 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients over age 18 and scheduled for open lumbar spine surgery (primary or revision)
- Must be able to swallow tablets
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery
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 detailed 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.
- Conditions
- Blood Loss, Surgical, Blood Loss Anemia
- Being tested
- Tranexamic Acid
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Lysteda
To identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion in lumbar spine surgery.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Tranexamic Acid | Active comparator | 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. Receives: Drug: Tranexamic Acid |
| Oral Tranexamic Acid | Active comparator | The oral TXA group will receive 1950 mg TXA (3 tablets of 650 mg) approximately 2 hours before incision. Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-operative blood loss between the two groups
For males: BV = 0.3669*(Height in meters)^3 + 0.03219*(Weight in kilograms) + 0.6041 For females: BV = 0.3561*(Height in meters)^3 + 0.03308*(Weight in kilograms) + 0.1833 Hbloss = BV*(Hbi-Hbe )*0.001 + Hbt Blood loss = 1000*(Hbloss/Hbi) Hbloss = Hemoglobin loss; BV = Blood Volume; Hbi = initial Hgb; Hbe = ending Hgb; Hbt = transfused Hgb = about 52g (SD 5.4g) per 1u pRBC (320mL)
Measured: Day of surgery to 1 day after surgery, up to 7 days
Secondary outcomes (5)
Post-operative drop in hemoglobin between the two groups
Measured: 1 day after surgery until patient is discharged, up to 7 days
Post-operative blood loss between the two groups
Measured: 1 day after surgery until patient is discharged, up to 7 days
Number of units transfused between the two groups
Measured: 1 day after surgery until patient is discharged, up to 7 days
Post-operative drain output between the two groups
Measured: 1 day after surgery until patient is discharged, up to 7 days
Incidence of thromboembolic events between the two groups
Measured: 1 day after surgery until patient returns for first postoperative visit (through study completion, an average of 4 weeks after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start15 Feb 2017
- Primary completion15 Jun 2018
- Study completion16 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles S Day, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037515
- Sponsor's protocol ID
- 10608
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2017
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
PubMed 21936146Good L, Peterson E, Lisander B. Tranexamic acid decreases external blood loss but not hidden blood loss in total knee replacement. Br J Anaesth. 2003 May;90(5):596-9. doi: 10.1093/bja/aeg111.
PubMed 12697586
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery
- ClinicalTrials.gov ID
- NCT03037515
- Acronym / sponsor ID
- 10608
- Conditions
- Blood Loss, Surgical, Blood Loss Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 16 Jul 2018 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Tranexamic Acid | Active comparator | Drug: Tranexamic AcidThe 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. |
| Oral Tranexamic Acid | Active comparator | Drug: Tranexamic AcidThe oral TXA group will receive 1950 mg TXA (3 tablets of 650 mg) approximately 2 hours before incision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients over age 18 and scheduled for open lumbar spine surgery (primary or revision)
- Must be able to swallow tablets
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic AcidAlso: LystedaTo identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion in lumbar spine surgery. | Drug | Intravenous Tranexamic Acid, Oral Tranexamic Acid |
Primary outcome
Intra-operative blood loss between the two groups
Time frame: Day of surgery to 1 day after surgery, up to 7 days
For males: BV = 0.3669*(Height in meters)^3 + 0.03219*(Weight in kilograms) + 0.6041 For females: BV = 0.3561*(Height in meters)^3 + 0.03308*(Weight in kilograms) + 0.1833 Hbloss = BV*(Hbi-Hbe )*0.001 + Hbt Blood loss = 1000*(Hbloss/Hbi) Hbloss = Hemoglobin loss; BV = Blood Volume; Hbi = initial Hgb; Hbe = ending Hgb; Hbt = transfused Hgb = about 52g (SD 5.4g) per 1u pRBC (320mL)
5 secondary outcomes
Post-operative drop in hemoglobin between the two groups
Time frame: 1 day after surgery until patient is discharged, up to 7 days
Post-operative blood loss between the two groups
Time frame: 1 day after surgery until patient is discharged, up to 7 days
Number of units transfused between the two groups
Time frame: 1 day after surgery until patient is discharged, up to 7 days
Post-operative drain output between the two groups
Time frame: 1 day after surgery until patient is discharged, up to 7 days
Incidence of thromboembolic events between the two groups
Time frame: 1 day after surgery until patient returns for first postoperative visit (through study completion, an average of 4 weeks after surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 21936146Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
- Background: PubMed 12697586Good L, Peterson E, Lisander B. Tranexamic acid decreases external blood loss but not hidden blood loss in total knee replacement. Br J Anaesth. 2003 May;90(5):596-9. doi: 10.1093/bja/aeg111.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid in people with Blood Loss, Surgical and Blood Loss Anemia, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-operative blood loss between the two groups (time frame: Day of surgery to 1 day after surgery, up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03037515, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.