Lumbar Spinal StenosisPhase 4NCT02063035
Effectiveness Study of the Drug Tranexamic Acid to Reduce Post-surgery Blood Loss in Spinal Surgery
A Phase 4 study testing Tranexamic Acid in people with Lumbar Spinal Stenosis and Thoracic Spinal Stenosis, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lumbar Spinal Stenosis, Thoracic Spinal Stenosis
- What is being tested?
- Tranexamic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to 22 Apr 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-85 years, both male and female
- Undergoing elective multi-level spinal surgery with a posterior approach to the thoracolumbar spine.
- Negative pregnancy test
Who cannot join
- Allergy to tranexamic acid
- Preoperative anemia (Hemoglobin <11 grams per deciliter [g/dL] )
- Coagulopathy (preoperative platelet count <150,000, International Normalized Ratio >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)
Show all 10Show fewer
- Infection
- Revision procedure in which the only procedure is removing instrumentation
- Renal impairment
- Dural tear
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Orthopedic Spine
Boston, Massachusetts, 02114
About this study
Official title: Topical Application of Tranexamic Acid to Reduce Postoperative Blood Loss in Posterior Approach Spinal Surgery
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.
Read the detailed description
Tranexamic acid, an antifibrinolytic agent, has been studied at great length across a myriad of medical specialties to reduce blood lost during these surgeries. Topical tranexamic acid administration reduces postoperative blood loss and proved safe in multiple types of surgeries -e.g. cardiothoracic, oral and maxillofacial, eye, ear and throat.(References: Fawzy and others [et al], Wong et al, Zufferey et al, Wang et al, Ipema et al).
Intravenous tranexamic acid administration has been shown to reduce postoperative blood loss and transfusion need in patients undergoing spinal surgery (Reference: Elwatidy et al). Some advocates have suggested that topical (i.e. local) administration might be preferred over intravenous application. Topical administration of tranexamic acid has some potential advantages as it leads to lower systemic absorption, and offers less concern over the risk of thromboembolic complications (References: Wong et al, Raveendran et al).
While systemic (intravenous) use of tranexamic acid has been studied in spine surgery, there has been little studied to show its effectiveness at reducing blood loss when used topically.
This study proposes to determine if the topical application of tranexamic acid into the surgical wound of posterior multi-level lumbar spine surgery will decrease postoperative blood loss, thus decreasing the need for potential transfusions. Tranexamic acid has been well documented for its safety and efficacy, the investigators believe that this agent will become an important tool to reduce the blood loss in spinal surgeries. It offers a reduction in blood loss and, ultimately, a decrease in the transfusion rates which pose risks to the subject and significant cost.
- Conditions
- Lumbar Spinal Stenosis, Thoracic Spinal Stenosis
- Being tested
- Tranexamic Acid, Placebo
- Keywords
- lumbar spine surgery, thoracic spine surgery
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Cyklokapron®
A single topical application of 3 grams (g) of Tranexamic acid in 100 milliliter (mL) saline.
PlaceboDrug
A single topical application of matching placebo, which is 100 mL of normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | Participants undergoing spinal surgery will receive a single, topical dose of tranexamic acid. The surgeon will irrigate the study medication in the wound prior to closure, and aspirate it after five minutes. Drains will be placed after the study drug has been aspirated. Receives: Drug: Tranexamic Acid |
| Placebo | Placebo comparator | Participants undergoing spinal surgery will receive a single, topical dose of matching placebo. The surgeon will irrigate the study medication in the wound prior to closure, and aspirate it after five minutes. Drains will be placed after the study drug has been aspirated. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin Level From Preoperative Appointment to Postoperative Hospital Discharge
Blood loss was calculated from the difference between the level of hemoglobin at the preoperative appointment and the lowest level during the postoperative hospitalization period. Reported here is the change in hemoglobin level after surgery. A negative number indicates a reduction in hemoglobin level.
Measured: From preoperative appointment approximately one week before surgery to end of hospital stay up to approximately 5 days after surgery
Secondary outcomes (3)
Blood Loss Volume Following Surgery
Blood loss following surgery was defined as the total amount of fluid collected from the drain in the wound site during the hospital stay.
Measured: From end of surgery on Day 1 to end of hospital stay up to approximately 5 days
Hospital Length of Stay in Days
The number of days the participants stayed in the hospital after surgery was recorded.
Measured: From end of surgery on Day 1 to end of hospital stay up to approximately 2 weeks
Post-operative Blood Transfusions During Hospitalization
All units of blood transfused during the hospital stay after surgery were recorded. One red blood cell unit contains 300 to 360 mL of whole blood.
Measured: From end of surgery on Day 1 to end of hospital stay up to approximately 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startAug 2012
- Primary completion22 Apr 2015
- Study completion22 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirkham Wood, Massachusetts General Hospital
- Investigators
- Kirkham B Wood, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063035
- Sponsor's protocol ID
- 2012P000266
- Other IDs
- 2012P000266
- Status last verified
- Jun 2017
- First submitted
- 19 Dec 2013
- Last updated
- 8 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fawzy H, Elmistekawy E, Bonneau D, Latter D, Errett L. Can local application of Tranexamic acid reduce post-coronary bypass surgery blood loss? A randomized controlled trial. J Cardiothorac Surg. 2009 Jun 18;4:25. doi: 10.1186/1749-8090-4-25.
PubMed 19538741Gill JB, Chin Y, Levin A, Feng D. The use of antifibrinolytic agents in spine surgery. A meta-analysis. J Bone Joint Surg Am. 2008 Nov;90(11):2399-407. doi: 10.2106/JBJS.G.01179.
PubMed 18978408Thompson GH, Florentino-Pineda I, Poe-Kochert C. The role of amicar in decreasing perioperative blood loss in idiopathic scoliosis. Spine (Phila Pa 1976). 2005 Sep 1;30(17 Suppl):S94-9. doi: 10.1097/01.brs.0000175188.05542.a9.
PubMed 16138073Hynes MC, Calder P, Rosenfeld P, Scott G. The use of tranexamic acid to reduce blood loss during total hip arthroplasty: an observational study. Ann R Coll Surg Engl. 2005 Mar;87(2):99-101. doi: 10.1308/147870805X28118.
PubMed 15826417Elwatidy S, Jamjoom Z, Elgamal E, Zakaria A, Turkistani A, El-Dawlatly A. Efficacy and safety of prophylactic large dose of tranexamic acid in spine surgery: a prospective, randomized, double-blind, placebo-controlled study. Spine (Phila Pa 1976). 2008 Nov 15;33(24):2577-80. doi: 10.1097/BRS.0b013e318188b9c5.
PubMed 19011538Wong J, Abrishami A, El Beheiry H, Mahomed NN, Roderick Davey J, Gandhi R, Syed KA, Muhammad Ovais Hasan S, De Silva Y, Chung F. Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. J Bone Joint Surg Am. 2010 Nov 3;92(15):2503-13. doi: 10.2106/JBJS.I.01518.
PubMed 21048170Raveendran R, Wong J. Tranexamic acid reduces blood transfusion in surgical patients while its effects on thromboembolic events and mortality are uncertain. Evid Based Med. 2013 Apr;18(2):65-6. doi: 10.1136/eb-2012-100872. Epub 2012 Aug 4. No abstract available.
PubMed 22864370Zufferey P, Merquiol F, Laporte S, Decousus H, Mismetti P, Auboyer C, Samama CM, Molliex S. Do antifibrinolytics reduce allogeneic blood transfusion in orthopedic surgery? Anesthesiology. 2006 Nov;105(5):1034-46. doi: 10.1097/00000542-200611000-00026.
PubMed 17065899Wang H, Shen B, Zeng Y. Comparison of topical versus intravenous tranexamic acid in primary total knee arthroplasty: a meta-analysis of randomized controlled and prospective cohort trials. Knee. 2014 Dec;21(6):987-93. doi: 10.1016/j.knee.2014.09.010. Epub 2014 Oct 23.
PubMed 25450009Ipema HJ, Tanzi MG. Use of topical tranexamic acid or aminocaproic acid to prevent bleeding after major surgical procedures. Ann Pharmacother. 2012 Jan;46(1):97-107. doi: 10.1345/aph.1Q383. Epub 2011 Dec 27.
PubMed 22202494
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Application of Tranexamic Acid to Reduce Postoperative Blood Loss in Posterior Approach Spinal Surgery
- ClinicalTrials.gov ID
- NCT02063035
- Acronym / sponsor ID
- 2012P000266
- Conditions
- Lumbar Spinal Stenosis, Thoracic Spinal Stenosis
- Keywords
- lumbar spine surgery, thoracic spine surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- 22 Apr 2015 (actual)
- Study completion
- 22 Apr 2015 (actual)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Posted 8 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Tranexamic acid, an antifibrinolytic agent, has been studied at great length across a myriad of medical specialties to reduce blood lost during these surgeries. Topical tranexamic acid administration reduces postoperative blood loss and proved safe in multiple types of surgeries -e.g. cardiothoracic, oral and maxillofacial, eye, ear and throat.(References: Fawzy and others [et al], Wong et al, Zufferey et al, Wang et al, Ipema et al).
Intravenous tranexamic acid administration has been shown to reduce postoperative blood loss and transfusion need in patients undergoing spinal surgery (Reference: Elwatidy et al). Some advocates have suggested that topical (i.e. local) administration might be preferred over intravenous application. Topical administration of tranexamic acid has some potential advantages as it leads to lower systemic absorption, and offers less concern over the risk of thromboembolic complications (References: Wong et al, Raveendran et al).
While systemic (intravenous) use of tranexamic acid has been studied in spine surgery, there has been little studied to show its effectiveness at reducing blood loss when used topically.
This study proposes to determine if the topical application of tranexamic acid into the surgical wound of posterior multi-level lumbar spine surgery will decrease postoperative blood loss, thus decreasing the need for potential transfusions. Tranexamic acid has been well documented for its safety and efficacy, the investigators believe that this agent will become an important tool to reduce the blood loss in spinal surgeries. It offers a reduction in blood loss and, ultimately, a decrease in the transfusion rates which pose risks to the subject and significant cost.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic AcidParticipants undergoing spinal surgery will receive a single, topical dose of tranexamic acid. The surgeon will irrigate the study medication in the wound prior to closure, and aspirate it after five minutes. Drains will be placed after the study drug has been aspirated. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants undergoing spinal surgery will receive a single, topical dose of matching placebo. The surgeon will irrigate the study medication in the wound prior to closure, and aspirate it after five minutes. Drains will be placed after the study drug has been aspirated. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-85 years, both male and female
- Undergoing elective multi-level spinal surgery with a posterior approach to the thoracolumbar spine.
- Negative pregnancy test
Key exclusion criteria (10 listed)
- Allergy to tranexamic acid
- Preoperative anemia (Hemoglobin <11 grams per deciliter [g/dL] )
- Coagulopathy (preoperative platelet count <150,000, International Normalized Ratio >1.4, or Partial Thromboplastin Time > 1.5 times normal)
- History of deep vein thrombosis, stroke, or pulmonary embolism
- Pregnant or breast feeding
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: Cyklokapron®A single topical application of 3 grams (g) of Tranexamic acid in 100 milliliter (mL) saline. | Drug | Tranexamic acid |
| PlaceboA single topical application of matching placebo, which is 100 mL of normal saline. | Drug | Placebo |
Primary outcome
Change in Hemoglobin Level From Preoperative Appointment to Postoperative Hospital Discharge
Time frame: From preoperative appointment approximately one week before surgery to end of hospital stay up to approximately 5 days after surgery
Blood loss was calculated from the difference between the level of hemoglobin at the preoperative appointment and the lowest level during the postoperative hospitalization period. Reported here is the change in hemoglobin level after surgery. A negative number indicates a reduction in hemoglobin level.
3 secondary outcomes
Blood Loss Volume Following Surgery
Time frame: From end of surgery on Day 1 to end of hospital stay up to approximately 5 days
Hospital Length of Stay in Days
Time frame: From end of surgery on Day 1 to end of hospital stay up to approximately 2 weeks
Post-operative Blood Transfusions During Hospitalization
Time frame: From end of surgery on Day 1 to end of hospital stay up to approximately 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19538741Fawzy H, Elmistekawy E, Bonneau D, Latter D, Errett L. Can local application of Tranexamic acid reduce post-coronary bypass surgery blood loss? A randomized controlled trial. J Cardiothorac Surg. 2009 Jun 18;4:25. doi: 10.1186/1749-8090-4-25.
- Background: PubMed 18978408Gill JB, Chin Y, Levin A, Feng D. The use of antifibrinolytic agents in spine surgery. A meta-analysis. J Bone Joint Surg Am. 2008 Nov;90(11):2399-407. doi: 10.2106/JBJS.G.01179.
- Background: PubMed 16138073Thompson GH, Florentino-Pineda I, Poe-Kochert C. The role of amicar in decreasing perioperative blood loss in idiopathic scoliosis. Spine (Phila Pa 1976). 2005 Sep 1;30(17 Suppl):S94-9. doi: 10.1097/01.brs.0000175188.05542.a9.
- Background: PubMed 15826417Hynes MC, Calder P, Rosenfeld P, Scott G. The use of tranexamic acid to reduce blood loss during total hip arthroplasty: an observational study. Ann R Coll Surg Engl. 2005 Mar;87(2):99-101. doi: 10.1308/147870805X28118.
- Background: PubMed 19011538Elwatidy S, Jamjoom Z, Elgamal E, Zakaria A, Turkistani A, El-Dawlatly A. Efficacy and safety of prophylactic large dose of tranexamic acid in spine surgery: a prospective, randomized, double-blind, placebo-controlled study. Spine (Phila Pa 1976). 2008 Nov 15;33(24):2577-80. doi: 10.1097/BRS.0b013e318188b9c5.
- Background: PubMed 21048170Wong J, Abrishami A, El Beheiry H, Mahomed NN, Roderick Davey J, Gandhi R, Syed KA, Muhammad Ovais Hasan S, De Silva Y, Chung F. Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. J Bone Joint Surg Am. 2010 Nov 3;92(15):2503-13. doi: 10.2106/JBJS.I.01518.
- Background: PubMed 22864370Raveendran R, Wong J. Tranexamic acid reduces blood transfusion in surgical patients while its effects on thromboembolic events and mortality are uncertain. Evid Based Med. 2013 Apr;18(2):65-6. doi: 10.1136/eb-2012-100872. Epub 2012 Aug 4. No abstract available.
- Background: PubMed 17065899Zufferey P, Merquiol F, Laporte S, Decousus H, Mismetti P, Auboyer C, Samama CM, Molliex S. Do antifibrinolytics reduce allogeneic blood transfusion in orthopedic surgery? Anesthesiology. 2006 Nov;105(5):1034-46. doi: 10.1097/00000542-200611000-00026.
- Background: PubMed 25450009Wang H, Shen B, Zeng Y. Comparison of topical versus intravenous tranexamic acid in primary total knee arthroplasty: a meta-analysis of randomized controlled and prospective cohort trials. Knee. 2014 Dec;21(6):987-93. doi: 10.1016/j.knee.2014.09.010. Epub 2014 Oct 23.
- Background: PubMed 22202494Ipema HJ, Tanzi MG. Use of topical tranexamic acid or aminocaproic acid to prevent bleeding after major surgical procedures. Ann Pharmacother. 2012 Jan;46(1):97-107. doi: 10.1345/aph.1Q383. Epub 2011 Dec 27.
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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.
Kirkham B Wood, MD principal investigator
Massachusetts General Hospital
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 Lumbar Spinal Stenosis and Thoracic Spinal Stenosis, run by Massachusetts General Hospital 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 3 inclusion and 10 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 8 Jun 2017. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 8 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Hemoglobin Level From Preoperative Appointment to Postoperative Hospital Discharge (time frame: From preoperative appointment approximately one week before surgery to end of hospital stay up to approximately 5 days after surgery). 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 NCT02063035, which also lists 10 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 8 Jun 2017.