Spine SurgeryPhase 4NCT04312880
Tranexamic Acid Infusion During Elective Spine Surgery
A Phase 4 study testing Tranexamic Acid in people with Spine Surgery, run by Albany Medical College at 1 site in United States.
Trial summary
Tranexamic acid (TXA) is an agent that has been shown to be safe and effective to reduce blood loss in surgical procedures. The purpose of the study is to assess the effect of transexamic on elective decompressive lumbar spine surgery with and without fusion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spine Surgery
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 1 Jan 2021
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Patients undergoing decompressive lumbar laminectomy with or without fusion
- Primary surgical procedure
- Competent adult able to give informed consent
- Age >18
Who cannot join
- h/o DVT or PE
- h/o seizure
- h/o coagulopathy
- Diagnosis of malignancy or infection as indication for surgical decompression
- Abnormal pre-operative PT/INR, aPTT, bleeding time
- Platelet count < 100
Show all 10Show fewer
- Patients requiring therapeutic heparin or lovenox bridges prior to and/or after surgery
- Allergy to TXA
- Pregnant women and prisoners
- Renal insufficiency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Tranexamic acid (TXA) is an agent that has been shown to be safe and effective to reduce blood loss in surgical procedures. The purpose of the study is to assess the effect of transexamic on elective decompressive lumbar spine surgery with and without fusion.
Read the detailed description
This will be a prospective randomized control, double-blinded investigation. The Investigators will recruit patients undergoing elective, primary, decompressive lumbar surgery via a posterior surgical approach of less than 3 levels. This includes patients undergoing decompressive lumbar laminectomies with or without fusion. Fusion may include posterior interbody and/or posterior lateral techniques with instrumentation.
There will be 3 treatment arms with the goal of 65 patients in each arm. Patients will be randomized pre-operatively and enrolled into the IV transexamic acid group (receiving intraoperative intravenous tranexamic acid infusion), or the topical transexamic acid group or the control/placebo group (receiving intraoperative intravenous saline). The Investigators expect the duration of each treatment group to be approximately 4-5 months. Therefore, the study should be completed within 1.5 years. The primary surgeon and anesthesia staff will not be blinded to the treatment arm due to the nature of the different administration routes, but post-operative nursing staff will be blinded to administration routes.
- Conditions
- Spine Surgery
- Being tested
- Tranexamic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
IV and topical form of TXA will be administered to patients in the respective groups.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patient will receive no transexemic acid of any kind |
| IV-transexemic acid | Experimental | weight adjusted standard dose of TXA will be administered to these subset of patients prior to incision in IV-form Receives: Drug: Tranexamic Acid |
| Topical-transexemic acid | Experimental | the wound site after the surgery is completed will be bathed in TXA for a standardized period of time prior to skin closure Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drain output
Drains will be placed during surgery, this will be recorded by nursing staff on a regular schedule and we will assess the results as a surrogate for blood loss post operatively
Measured: 48 hours postoperatively
Secondary outcomes (6)
Change in hematocrit
Labs will be recorded each morning after the surgery, this includes hematocrit
Measured: two days post operatively
Change in hemoglobin
Labs will be recorded each morning after the surgery, this includes hemoglobin
Measured: two days post operatively
Emergency department visits
We will assess which treatment arms, if any had increased rate of Emergency department visits for any reason
Measured: 30 days post operatively
number of hospital readmissions
We will assess which treatment arms, if any had increased rate of readmission to the hospital
Measured: 30 days post operatively
Incidence of PE
We will assess is any treatment arm had an increased risk of PE
Measured: 30 days post opertively
Incidence of DVT
We will assess is any treatment arm had an increased risk of DVT
Measured: 30 days post opertively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start1 Dec 2018
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (estimated)
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Lawrence, MD, Principal investigator, Attending Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312880
- Sponsor's protocol ID
- 5176
- Status last verified
- Aug 2020
- First submitted
- 9 Mar 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- 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 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid Infusion During Elective Spine Surgery
- ClinicalTrials.gov ID
- NCT04312880
- Acronym / sponsor ID
- 5176
- Conditions
- Spine Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 18 Mar 2020 (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.
Tranexamic acid (TXA) is an agent that has been shown to be safe and effective to reduce blood loss in surgical procedures. The purpose of the study is to assess the effect of transexamic on elective decompressive lumbar spine surgery with and without fusion.
Detailed description
This will be a prospective randomized control, double-blinded investigation. The Investigators will recruit patients undergoing elective, primary, decompressive lumbar surgery via a posterior surgical approach of less than 3 levels. This includes patients undergoing decompressive lumbar laminectomies with or without fusion. Fusion may include posterior interbody and/or posterior lateral techniques with instrumentation.
There will be 3 treatment arms with the goal of 65 patients in each arm. Patients will be randomized pre-operatively and enrolled into the IV transexamic acid group (receiving intraoperative intravenous tranexamic acid infusion), or the topical transexamic acid group or the control/placebo group (receiving intraoperative intravenous saline). The Investigators expect the duration of each treatment group to be approximately 4-5 months. Therefore, the study should be completed within 1.5 years. The primary surgeon and anesthesia staff will not be blinded to the treatment arm due to the nature of the different administration routes, but post-operative nursing staff will be blinded to administration routes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patient will receive no transexemic acid of any kind |
| IV-transexemic acid | Experimental | Drug: Tranexamic Acidweight adjusted standard dose of TXA will be administered to these subset of patients prior to incision in IV-form |
| Topical-transexemic acid | Experimental | Drug: Tranexamic Acidthe wound site after the surgery is completed will be bathed in TXA for a standardized period of time prior to skin closure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing decompressive lumbar laminectomy with or without fusion
- Primary surgical procedure
- Competent adult able to give informed consent
- Age >18
Key exclusion criteria (10 listed)
- h/o DVT or PE
- h/o seizure
- h/o coagulopathy
- Diagnosis of malignancy or infection as indication for surgical decompression
- Abnormal pre-operative PT/INR, aPTT, bleeding time
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 AcidIV and topical form of TXA will be administered to patients in the respective groups. | Drug | IV-transexemic acid, Topical-transexemic acid |
Primary outcome
Drain output
Time frame: 48 hours postoperatively
Drains will be placed during surgery, this will be recorded by nursing staff on a regular schedule and we will assess the results as a surrogate for blood loss post operatively
6 secondary outcomes
Change in hematocrit
Time frame: two days post operatively
Change in hemoglobin
Time frame: two days post operatively
Emergency department visits
Time frame: 30 days post operatively
number of hospital readmissions
Time frame: 30 days post operatively
Incidence of PE
Time frame: 30 days post opertively
Incidence of DVT
Time frame: 30 days post opertively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Individual participant dataSharing planned: No
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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.
James Lawrence, MD principal investigator
Attending Surgeon
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 Spine Surgery, run by Albany Medical College 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 4 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: enrolling by invitation, as of the sponsor's last update on 12 Aug 2020. 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?
This study is still under way. Results are not available in the source record yet.
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?
Drain output (time frame: 48 hours postoperatively). 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 12 Aug 2020.