Spine SurgeryEarly Phase 1NCT04797156
Combined IV and Topical TXA in Major Spine Surgery
A Early Phase 1 study testing High Dose Tranexamic acid, Low Dose Tranexamic acid and Tranexamic acid Topical in people with Spine Surgery and Back Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This is a randomized study. The purpose of this study is to evaluate the effect of tranexamic acid in patients undergoing multilevel spine surgery. 75 patients undergoing multi-level spine surgery will be enrolled at Mount Sinai West. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spine Surgery, Back Pain
- What is being tested?
- High Dose Tranexamic acid, Low Dose Tranexamic acid and Tranexamic acid Topical
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2021to 15 Aug 2024
- Phase
- Early Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18-80 years old
- Undergo major multilevel spine surgery (2-8 levels)
- Male or female
Who cannot join
- ASA class V
- Urgent or emergent surgery,
- Morbid obesity
- Patients with known coagulopathy disorder, hx of thromboembolic event <1 year, renal insufficiency, hepatic dysfunction, serious cardiac disease
- Patients with known allergy to TXA or receiving antiplatelet and/or anticoagulant drugs
- Religious or other belief that limit blood transfusion,
- Surgery duration more than 6 hours
- Patient refusal or inability to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Combined Intravenous and Topical TXA in Major Multilevel Spine Surgery: A Prospective Randomized Trial
This is a randomized study. The purpose of this study is to evaluate the effect of tranexamic acid in patients undergoing multilevel spine surgery. 75 patients undergoing multi-level spine surgery will be enrolled at Mount Sinai West. Study participation will last from the time of pre-operative evaluation to the time of discharge from hospital. Specifically, the study team will compare tranexamic acid given only intravenously vs. given both topically and intravenously vs. given only intravenously but at a higher dosage. The study team hypothesizes that patient who received combined topical and intravenous TXA (low dose) have similar or decreased overall blood loss postoperatively compared to patient who received high or low dose intravenous TXA alone.
Read the detailed description
Prospective triple-blinded randomized control trial. The surgeon will provide study information (protocol, consent, general information) to patients in the surgeon's office. Recruitment will be done through a coordination of the operating schedule and the surgeon's office. Patients presenting for preoperative visits at the surgeon's office or the preoperative joint clinic will be approached. On the day of the surgery, the subject will meet the research team in the holding area. The team will finalize participation and ask the subject about the signed consent forms and answer any additional questions. All patients will be provided with copies of the IRB protocol and consent if they wish to have it. Copy of the consent form will be sent in a secured email to the potential subject. The email will be secured by entering in [SECURE] in the e-mail subject line. Once recruited blinding assessments will be done by the study team.
Patients will be assigned randomly using a computer-generated table of numbers to one of the three groups: 1) High Dose Intravenous TXA (hTXA group), 2) Low Dose Intravenous TXA (lTXA group), or 3) Combined Intravenous and Topical TXA group (cTXA group). Surgical team will perform the required spine procedure. Study personnel will make the medication which will be labelled as study drug for surgical and anesthesia team to give during the procedure. Patients assigned to hTXA group will receive 50mg/kg IV TXA loading dose with a 5mg/kg/hr maintenance dose, and normal saline poured over 5 minutes at the wound prior to closure. Patients assigned to lTXA group will receive 20mg/kg IV TXA loading dose with a 5mg/kg/hr maintenance dose, and normal saline poured over 5 minutes at the wound prior to closure. Patients assigned to cTXA group will received 20mg/kg V TXA loading dose with a 5mg/kg/hr maintenance dose, and 2g topical TXA poured over 5 minutes at the would prior to closure. Otherwise, the patient, surgeon, and anesthesiologist in the case will be blinded.
- Conditions
- Spine Surgery, Back Pain
- Being tested
- High Dose Tranexamic acid, Low Dose Tranexamic acid, Tranexamic acid Topical, Normal saline
- Keywords
- tranexamic acid, Spine surgery
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Dose Tranexamic acidDrug
Also called hTXA
50mg/kg IV TXA
Low Dose Tranexamic acidDrug
Also called lTXA
20mg/kg IV TXA
Tranexamic acid TopicalDrug
Also called TXA
2g topical TXA
Normal salineDrug
Also called NS
Normal saline poured on wound
| Study group | Role | What they receive |
|---|---|---|
| High Dose Intravenous TXA (hTXA group) | Experimental | Patients assigned to hTXA group will receive 50mg/kg IV TXA loading dose with a 5mg/kg/hr maintenance dose, and normal saline poured over 5 minutes at the wound prior to closure. Receives: Drug: High Dose Tranexamic acid; Drug: Normal saline |
| Low Dose Intravenous TXA (lTXA group) | Experimental | Patients assigned to lTXA group will receive 20mg/kg IV TXA loading dose with a 5mg/kg/hr maintenance dose, and normal saline poured over 5 minutes at the wound prior to closure. Receives: Drug: Low Dose Tranexamic acid; Drug: Normal saline |
| Combined Intravenous and Topical TXA group (cTXA group) | Placebo comparator | Patients assigned to cTXA group will received 20mg/kg V TXA loading dose with a 5mg/kg/hr maintenance dose, and 2g topical TXA poured over 5 minutes at the would prior to closure Receives: Drug: Low Dose Tranexamic acid; Drug: Tranexamic acid Topical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hematocrit level
The amount of post-operative blood loss during the first 24, 48 and 72 hours in patients undergoing multilevel spine surgery. Specifically, the hematocrit number difference between baseline and post-operative day 1, 2 and 3.
Measured: Baseline and Post-operative day 1, 2 and 3
Secondary outcomes (1)
Post-operative drain output
The amount of post-operative drain output (ml) during the first 24, 48 and 72 hours in patients undergoing multilevel spine surgery.
Measured: Post-operative day 1, 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start3 Mar 2021
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Patients will be assigned randomly using a computer-generated table of numbers to one of the three groups: 1. High Dose Intravenous TXA (hTXA group) 2. Low Dose Intravenous TXA (lTXA group) 3. Combined Intravenous and Topical TXA group (cTXA group).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Lai, Icahn School of Medicine at Mount Sinai
- Investigators
- Yan Lai, M.D., Principal investigator, Mount Sinai West and Morningside Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797156
- Sponsor's protocol ID
- GCO 19-1137
- Status last verified
- Apr 2025
- First submitted
- 10 Mar 2021
- Last updated
- 4 Apr 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combined Intravenous and Topical TXA in Major Multilevel Spine Surgery: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04797156
- Acronym / sponsor ID
- GCO 19-1137
- Conditions
- Spine Surgery, Back Pain
- Keywords
- tranexamic acid, Spine surgery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 15 Mar 2021 (actual)
- 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.
This is a randomized study. The purpose of this study is to evaluate the effect of tranexamic acid in patients undergoing multilevel spine surgery. 75 patients undergoing multi-level spine surgery will be enrolled at Mount Sinai West. Study participation will last from the time of pre-operative evaluation to the time of discharge from hospital. Specifically, the study team will compare tranexamic acid given only intravenously vs. given both topically and intravenously vs. given only intravenously but at a higher dosage. The study team hypothesizes that patient who received combined topical and intravenous TXA (low dose) have similar or decreased overall blood loss postoperatively compared to patient who received high or low dose intravenous TXA alone.
Detailed description
Prospective triple-blinded randomized control trial. The surgeon will provide study information (protocol, consent, general information) to patients in the surgeon's office. Recruitment will be done through a coordination of the operating schedule and the surgeon's office. Patients presenting for preoperative visits at the surgeon's office or the preoperative joint clinic will be approached. On the day of the surgery, the subject will meet the research team in the holding area. The team will finalize participation and ask the subject about the signed consent forms and answer any additional questions. All patients will be provided with copies of the IRB protocol and consent if they wish to have it. Copy of the consent form will be sent in a secured email to the potential subject. The email will be secured by entering in [SECURE] in the e-mail subject line. Once recruited blinding assessments will be done by the study team.
Patients will be assigned randomly using a computer-generated table of numbers to one of the three groups: 1) High Dose Intravenous TXA (hTXA group), 2) Low Dose Intravenous TXA (lTXA group), or 3) Combined Intravenous and Topical TXA group (cTXA group). Surgical team will perform the required spine procedure. Study personnel will make the medication which will be labelled as study drug for surgical and anesthesia team to give during the procedure. Patients assigned to hTXA group will receive 50mg/kg IV TXA loading dose with a 5mg/kg/hr maintenance dose, and normal saline poured over 5 minutes at the wound prior to closure. Patients assigned to lTXA group will receive 20mg/kg IV TXA loading dose with a 5mg/kg/hr maintenance dose, and normal saline poured over 5 minutes at the wound prior to closure. Patients assigned to cTXA group will received 20mg/kg V TXA loading dose with a 5mg/kg/hr maintenance dose, and 2g topical TXA poured over 5 minutes at the would prior to closure. Otherwise, the patient, surgeon, and anesthesiologist in the case will be blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be assigned randomly using a computer-generated table of numbers to one of the three groups: 1. High Dose Intravenous TXA (hTXA group) 2. Low Dose Intravenous TXA (lTXA group) 3. Combined Intravenous and Topical TXA group (cTXA group).
| Arm | Type | Receives |
|---|---|---|
| High Dose Intravenous TXA (hTXA group) | Experimental | Drug: High Dose Tranexamic acid, Drug: Normal salinePatients assigned to hTXA group will receive 50mg/kg IV TXA loading dose with a 5mg/kg/hr maintenance dose, and normal saline poured over 5 minutes at the wound prior to closure. |
| Low Dose Intravenous TXA (lTXA group) | Experimental | Drug: Low Dose Tranexamic acid, Drug: Normal salinePatients assigned to lTXA group will receive 20mg/kg IV TXA loading dose with a 5mg/kg/hr maintenance dose, and normal saline poured over 5 minutes at the wound prior to closure. |
| Combined Intravenous and Topical TXA group (cTXA group) | Placebo comparator | Drug: Low Dose Tranexamic acid, Drug: Tranexamic acid TopicalPatients assigned to cTXA group will received 20mg/kg V TXA loading dose with a 5mg/kg/hr maintenance dose, and 2g topical TXA poured over 5 minutes at the would prior to closure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18-80 years old
- Undergo major multilevel spine surgery (2-8 levels)
- Male or female
Key exclusion criteria (8 listed)
- ASA class V
- Urgent or emergent surgery,
- Morbid obesity
- Patients with known coagulopathy disorder, hx of thromboembolic event <1 year, renal insufficiency, hepatic dysfunction, serious cardiac disease
- Patients with known allergy to TXA or receiving antiplatelet and/or anticoagulant drugs
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 |
|---|---|---|
| High Dose Tranexamic acidAlso: hTXA50mg/kg IV TXA | Drug | High Dose Intravenous TXA (hTXA group) |
| Low Dose Tranexamic acidAlso: lTXA20mg/kg IV TXA | Drug | Combined Intravenous and Topical TXA group (cTXA group), Low Dose Intravenous TXA (lTXA group) |
| Tranexamic acid TopicalAlso: TXA2g topical TXA | Drug | Combined Intravenous and Topical TXA group (cTXA group) |
| Normal salineAlso: NSNormal saline poured on wound | Drug | High Dose Intravenous TXA (hTXA group), Low Dose Intravenous TXA (lTXA group) |
Primary outcome
Change in Hematocrit level
Time frame: Baseline and Post-operative day 1, 2 and 3
The amount of post-operative blood loss during the first 24, 48 and 72 hours in patients undergoing multilevel spine surgery. Specifically, the hematocrit number difference between baseline and post-operative day 1, 2 and 3.
1 secondary outcome
Post-operative drain output
Time frame: Post-operative day 1, 2 and 3
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 4 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Spine Surgery
Not yet recruiting
Adding Different Doses of Dexmedetomidine to Bupivecaine in Erector Spinae Plane Block
Postoperative Pain in Lumbar Spine Surgery
Recruiting
Lumbar Paravertebral Block vs Erector Spinae Plane Block in Elderly Patients Undergoing Lumbar Spine Surgery
Spine Disease
Recruiting
FIBERGRAFT Aeridyan Posterolateral Fusion Study
Degenerative Spine Disease
RecruitingPhase 4
Perioperative Rectal Methadone in Spine Surgery
Spinal Surgery, Post-operative Care
Not yet recruiting
MALMOS Technique for Selected Subaxial Cervical Spine Fractures
Cervical Spine Fractures
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.
Yan Lai, M.D. principal investigator
Mount Sinai West and Morningside Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing High Dose Tranexamic acid, Low Dose Tranexamic acid and Tranexamic acid Topical in people with Spine Surgery and Back Pain, run by Icahn School of Medicine at Mount Sinai 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 8 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 4 Apr 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in Hematocrit level (time frame: Baseline and Post-operative day 1, 2 and 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2025.