Pharmacological ActionPhase 4NCT03714360
The Effect of Tranexamic Acid. A Randomised Study of Patients Undergoing Elective Lumbar Spine Surgery.
A Phase 4 study testing Tranexamic Acid and Sodium Chloride 0,9% in people with Pharmacological Action, run by Mikkel Østerheden Andersen at 1 site in Denmark.
Trial summary
In this randomized double blind placebo controlled study of tranexamic acid during minor spinal surgery, mean postoperative blood loss in the patients who received TXA was statistically significantly lower compared to placebo. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pharmacological Action
- What is being tested?
- Tranexamic Acid and Sodium Chloride 0,9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Oct 2015to 16 Aug 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients referred to the Centre for Spine Surgery and Research in the Region of Southern Denmark with symptomatic, MRI-verified lumbar spinal stenosis or disc herniations
- low risk (American Society of Anesthesiologists, ASA, score 1-2) adult patients scheduled for elective primary decompression or/and discectomy over one to two vertebral levels (without fusion or instrumentation), willing to give informed consent.
Who cannot join
- Not able to understand verbal and/or written Danish ASA score more than 2 Malignant disease Pregnancy Breast feeding
- Contraindications to TXA:
- Active thromboembolic disease Coagulopathy History of venous or arterial thrombosis Hypersensitivity to the active substance Disseminated intravascular coagulation Severe renal impairment History of convulsions ASA - American Society of Anesthesiologists score, TXA - Tranexamic acid.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Tranexamic Acid on Duration of Surgery, Bleeding and Complications. A Double Blind, Placebo-controlled, Randomised Study of Patients Undergoing Elective Lumbar Spine Surgery.
In this randomized double blind placebo controlled study of tranexamic acid during minor spinal surgery, mean postoperative blood loss in the patients who received TXA was statistically significantly lower compared to placebo.
Read the detailed description
Study Design: Double-blind, randomized, placebo-controlled, parallel-group study.
Objective: To investigate the effect of tranexamic acid (TXA) compared to placebo in low-risk adult patients undergoing elective minor lumbar spine surgery on operative time, estimated blood loss and complications.
Summary of Background Data: Studies have shown that TXA reduces blood loss during major spine surgery. There are no studies on the effect of TXA in minor lumbar spine surgery on operative time, intraoperative and postoperative blood loss and complications.
Methods: We enrolled patients with ASA grades 1 to 2, scheduled to undergo lumbar decompressive surgery at Middelfart Hospital. Patients with thromboembolic disease, coagulopathy, hypersensitivity to TXA or history of convulsion were excluded. Patients were randomized, in blocks of 10, to two groups: TXA or placebo. Anticoagulation therapy was discontinued 2-7 days preoperatively. Prior to the incision, patients received either a bolus of TXA (10mg/kg), or an equivalent volume of saline solution (placebo).
- Conditions
- Pharmacological Action
- Being tested
- Tranexamic Acid, Sodium Chloride 0,9%
- Keywords
- TXA;decompression; discectomy; operative time; blood loss
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called TXA
patients with ASA(American Society of Anesthesiologists grades) 1 to 2, scheduled to undergo lumbar decompressive surgery at Middelfart Hospital. Patients were randomized, in blocks of 10, to two groups: TXA or placebo. Anticoagulation therapy was discontinued 2-7 days preoperatively. Prior to the incision, patients received either a bolus of TXA (10mg/kg), or an equivalent volume of saline solution (placebo).
Sodium Chloride 0,9%Drug
Sodium Chloride 0,9%
| Study group | Role | What they receive |
|---|---|---|
| TXA tranexamic acid | Experimental | a single dose of 10 mg/kg of TXA, with a maximum dose of 1g. Administered as IV injection and marked as 'project-drug' and amount (mL) in the medical record. Receives: Drug: Tranexamic Acid |
| Sodium Chloride 0,9% | Placebo comparator | an equivalent volume 0.9 % Sodium Chloride. Receives: Drug: Sodium Chloride 0,9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Defined as the time in minutes from incision to closure (last stitch)
Measured: Intraoperative (The time in minutes from incision to closure (last stitch) was measured)
Secondary outcomes (1)
Perioperative bleeding and occurrence of dural tear, Deep venous thrombosis T.
Intra-operative blood loss was estimated by adding the weight (1g=1mL) of swabs and blood in the suction bottle and subtracting all fluids added to the surgical field. Surgical drain volume was estimated visually at two and 18 hours post-operatively. Total volume of peri-operative blood loss was calculated as the volume of intraoperative blood loss plus the post-operative volume measured from the drain output.
Measured: Surgical drain volume was estimated visually at two and 18 hours post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start19 Oct 2015
- Primary completion16 Aug 2016
- Study completion16 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pharmacological ActionStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mikkel Østerheden Andersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mikkel Østerheden Andersen, Spine Centre of Southern Denmark
- Investigators
- Mikkel Andersen, MD, Study chair, Sygehus Lillebaelt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714360
- Sponsor's protocol ID
- S-20150072
- Status last verified
- Jan 2025
- First submitted
- 15 Oct 2018
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet, so no plan except publishing the result in a scientific paper.
Publications
Elmose S, Andersen MO, Andresen EB, Carreon LY. Double-blind, randomized controlled trial of tranexamic acid in minor lumbar spine surgery: no effect on operative time, intraoperative blood loss, or complications. J Neurosurg Spine. 2019 Apr 12;31(2):194-200. doi: 10.3171/2019.1.SPINE1814. Print 2019 Aug 1.
PubMed 30978683
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tranexamic Acid on Duration of Surgery, Bleeding and Complications. A Double Blind, Placebo-controlled, Randomised Study of Patients Undergoing Elective Lumbar Spine Surgery.
- ClinicalTrials.gov ID
- NCT03714360
- Acronym / sponsor ID
- S-20150072
- Conditions
- Pharmacological Action
- Keywords
- TXA;decompression; discectomy; operative time; blood loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Mikkel Østerheden AndersenUniversity, hospital or other
- Study start
- 19 Oct 2015 (actual)
- Primary completion
- 16 Aug 2016 (actual)
- Study completion
- 16 Aug 2016 (actual)
- First posted
- 22 Oct 2018 (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.
In this randomized double blind placebo controlled study of tranexamic acid during minor spinal surgery, mean postoperative blood loss in the patients who received TXA was statistically significantly lower compared to placebo.
Detailed description
Study Design: Double-blind, randomized, placebo-controlled, parallel-group study.
Objective: To investigate the effect of tranexamic acid (TXA) compared to placebo in low-risk adult patients undergoing elective minor lumbar spine surgery on operative time, estimated blood loss and complications.
Summary of Background Data: Studies have shown that TXA reduces blood loss during major spine surgery. There are no studies on the effect of TXA in minor lumbar spine surgery on operative time, intraoperative and postoperative blood loss and complications.
Methods: We enrolled patients with ASA grades 1 to 2, scheduled to undergo lumbar decompressive surgery at Middelfart Hospital. Patients with thromboembolic disease, coagulopathy, hypersensitivity to TXA or history of convulsion were excluded. Patients were randomized, in blocks of 10, to two groups: TXA or placebo. Anticoagulation therapy was discontinued 2-7 days preoperatively. Prior to the incision, patients received either a bolus of TXA (10mg/kg), or an equivalent volume of saline solution (placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TXA tranexamic acid | Experimental | Drug: Tranexamic Acida single dose of 10 mg/kg of TXA, with a maximum dose of 1g. Administered as IV injection and marked as 'project-drug' and amount (mL) in the medical record. |
| Sodium Chloride 0,9% | Placebo comparator | Drug: Sodium Chloride 0,9%an equivalent volume 0.9 % Sodium Chloride. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients referred to the Centre for Spine Surgery and Research in the Region of Southern Denmark with symptomatic, MRI-verified lumbar spinal stenosis or disc herniations
- low risk (American Society of Anesthesiologists, ASA, score 1-2) adult patients scheduled for elective primary decompression or/and discectomy over one to two vertebral levels (without fusion or instrumentation), willing to give informed consent.
Key exclusion criteria (3 listed)
- Not able to understand verbal and/or written Danish ASA score more than 2 Malignant disease Pregnancy Breast feeding
- Active thromboembolic disease Coagulopathy History of venous or arterial thrombosis Hypersensitivity to the active substance Disseminated intravascular coagulation Severe renal impairment History of convulsions ASA - American Society of Anesthesiologists score, TXA - Tranexamic acid.
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: TXApatients with ASA(American Society of Anesthesiologists grades) 1 to 2, scheduled to undergo lumbar decompressive surgery at Middelfart Hospital. Patients were randomized, in blocks of 10, to two groups: TXA or placebo. Anticoagulation therapy was discontinued 2-7 days preoperatively. Prior to the incision, patients received either a bolus of TXA (10mg/kg), or an equivalent volume of saline solution (placebo). | Drug | TXA tranexamic acid |
| Sodium Chloride 0,9%Sodium Chloride 0,9% | Drug | Sodium Chloride 0,9% |
Primary outcome
Operative time
Time frame: Intraoperative (The time in minutes from incision to closure (last stitch) was measured)
Defined as the time in minutes from incision to closure (last stitch)
1 secondary outcome
Perioperative bleeding and occurrence of dural tear, Deep venous thrombosis T.
Time frame: Surgical drain volume was estimated visually at two and 18 hours post-operatively.
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 31 Jan 2025.
- Derived from this study: PubMed 30978683Elmose S, Andersen MO, Andresen EB, Carreon LY. Double-blind, randomized controlled trial of tranexamic acid in minor lumbar spine surgery: no effect on operative time, intraoperative blood loss, or complications. J Neurosurg Spine. 2019 Apr 12;31(2):194-200. doi: 10.3171/2019.1.SPINE1814. Print 2019 Aug 1.
- Individual participant dataSharing planned: Undecided. Not decided yet, so no plan except publishing the result in a scientific paper.
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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.
Mikkel Andersen, MD study chair
Sygehus Lillebaelt
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 and Sodium Chloride 0,9% in people with Pharmacological Action, run by Mikkel Østerheden Andersen at 1 site in Denmark.
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 3 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 31 Jan 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 Denmark. 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?
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?
Operative time (time frame: Intraoperative (The time in minutes from incision to closure (last stitch) was measured)). 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 NCT03714360, which also lists 1 linked publication.
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 31 Jan 2025.