Spinal FusionPhase 4NCT01136590
Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery
A Phase 4 study testing Tranexamic Acid and fisiologic serum in people with Spinal Fusion and Antifibrinolytic Agents, run by Hospital Universitari Vall d'Hebron Research Institute at 4 sites in Spain.
Trial summary
Current evidence regarding the efficacy and safety of perioperative administration of tranexamic acid for antifibrinolysis does not suffice to support its use in major spinal surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Fusion, Antifibrinolytic Agents, Hemorrhage
- What is being tested?
- Tranexamic Acid and fisiologic serum
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 4 sitesSpain
- Study dates
- Sep 2010to May 2014
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years old of both sexes
- scheduled for complex spine surgery
- ASA I-III
- weighing more than 30 kg
- body mass index <30 kg/m2
- operated on in the participating hospitals
- major spinal surgery
- signed an informed consent form to be included in the study
Who cannot join
- a history of allergy or hypersensitivity to the agent used
- receiving medication that can interfere with coagulation (acetylsalicylic acid, oral anticoagulants, or antiplatelet agents)
- a history of frequent bleeding
- plasma creatinine values >1.5 mg/dL in the baseline analysis
- platelet count less than 150,000/mm3 in the follow-up analysis
- abnormal prothrombin time (INR >1.5) or partial thromboplastin time (INR >1.5)
Show all 11Show fewer
- a history of a thromboembolic episode before surgery
- family history of thromboembolism
- lack of consent to participate in the study
- infectious disease, tumor or trauma of the spine as the reason for surgery
- scheduled for surgery with an anterior and posterior surgical approach, whether sequential or on the same day
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Clinic de Barcelona
Barcelona, Barcelona, 08029
Hospital Vall d'Hebron de Barcelona
Barcelona, Barcelona, 08035
Hospital de Getafe
Getafe, Madrid
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona
About this study
Current evidence regarding the efficacy and safety of perioperative administration of tranexamic acid for antifibrinolysis does not suffice to support its use in major spinal surgery.
OBJECTIVES: To evaluate the effectiveness of tranexamic acid for decreasing transfusion requirements and bleeding in this patient population. To evaluate the safety of this antifibrinolytic agent in the intraoperative and mid-term postoperative period.
METHODS: Multicenter, randomized, double-blind, placebo-controlled clinical trial with parallel groups. The main outcome measure is intraoperative and postoperative transfusion requirements; blood loss and safety will also be evaluated. Previous results in other types of surgery suggest that tranexamic acid reduces transfusion requirements and blood loss. Hence, the hypothesis of this study is that tranexamic acid will significantly reduce blood loss in comparison to a placebo in major spine surgery.
- Conditions
- Spinal Fusion, Antifibrinolytic Agents, Hemorrhage, Blood Transfusion
- Being tested
- Tranexamic Acid, fisiologic serum
- Keywords
- Spinal deformity correction, Surgical bleeding, Transfusion practice, Spinal Fusion, Antifibrinolytic Agents, Hemorrhage, Blood Transfusion
- 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
A 10-mg/kg dose of tranexamic acid will be administered as a bolus or as a fast, 20-minute intravenous infusion before performing the incision at the start of surgery, followed by perfusion of 2 mg/kg/hour up to the time the surgical wound is closed at completion of surgery.
fisiologic serumDrug
The placebo will be administered according to the same regimen and infusion time as the medication in the study arm (bolus or 20-minute fast infusion before the incision at the beginning of surgery followed by perfusion of 2 mg/kg/hour until closure of the surgical wound at completion of surgery)
| Study group | Role | What they receive |
|---|---|---|
| tranexamic acid | Experimental | tranexamic acid will be administered as a bolus (10-mg/kg dose ) or as a fast, 20-minute intravenous infusion before performing the incision at the start of surgery, followed by perfusion of 2 mg/kg/hour up to the time the surgical wound is closed at completion of surgery Receives: Drug: Tranexamic Acid |
| placebo | Placebo comparator | The placebo will be administered according to the same regimen and infusion time as the medication in the study arm (bolus or 20-minute fast infusion before the incision at the beginning of surgery followed by perfusion of 2 mg/kg/hour until closure of the surgical wound at completion of surgery) Receives: Drug: fisiologic serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the number of transfused units required during the intraoperative and postoperative period
Measured: 7 days postoperative period
Secondary outcomes (2)
Total blood loss: intraoperative and postoperative values
Intraoperative blood loss is evaluated by measuring the volume of suction aspirate and weighing the swabs with a precision digital scale. Postoperative blood loss is determined by recording the volume of blood collected through the suction drains at 24 and 48 hours.
Measured: 48 hours postoperative
Adverse events in the perioperative period, immediate postoperative period, and at mid-term
Adverse events in the perioperative period, immediate postoperative period, and at mid-term (up to 6 weeks after the procedure) will be recorded, with special emphasis on follow-up of thrombotic events and clinically suspected deep venous thrombosis, renal function, and visual abnormalities reported by the patient
Measured: up to 6 weeks after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startSep 2010
- Primary completionMay 2014
- Study completionMay 2014
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 Spinal FusionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Vall d'Hebron, Hospital Clinic of Barcelona, Hospital Universitari de Bellvitge, Hospital Universitario Getafe
- Responsible party
- Sponsor
- Investigators
- Maria J Colomina, MD Ph, Study chair, Hospital Vall d'HebronMisericordia Basora, MD Ph, Principal investigator, Hospital Clinic of BarcelonaMaylin Koo, MD Ph, Principal investigator, Hospital Universitari de BellvitgeJavier Pizones, MD, Principal investigator, Hospital de Getafe.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136590
- Sponsor's protocol ID
- TRANEX2009
- Other IDs
- 2008-006938-94, 2008
- Status last verified
- Feb 2015
- First submitted
- 2 Jun 2010
- Last updated
- 24 Feb 2015
- Results posted
- No
Publications
Colomina MJ, Koo M, Basora M, Pizones J, Mora L, Bago J. Intraoperative tranexamic acid use in major spine surgery in adults: a multicentre, randomized, placebo-controlled trialdagger. Br J Anaesth. 2017 Mar 1;118(3):380-390. doi: 10.1093/bja/aew434.
PubMed 28203735
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery
- ClinicalTrials.gov ID
- NCT01136590
- Acronym / sponsor ID
- TRANEX2009
- Conditions
- Spinal Fusion, Antifibrinolytic Agents, Hemorrhage, Blood Transfusion
- Keywords
- Spinal deformity correction, Surgical bleeding, Transfusion practice, Spinal Fusion, Antifibrinolytic Agents, Hemorrhage, Blood Transfusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Hospital Vall d'Hebron, Hospital Clinic of Barcelona, Hospital Universitari de Bellvitge, Hospital Universitario Getafe
- Study start
- Sep 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 3 Jun 2010 (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.
Current evidence regarding the efficacy and safety of perioperative administration of tranexamic acid for antifibrinolysis does not suffice to support its use in major spinal surgery.
OBJECTIVES: To evaluate the effectiveness of tranexamic acid for decreasing transfusion requirements and bleeding in this patient population. To evaluate the safety of this antifibrinolytic agent in the intraoperative and mid-term postoperative period.
METHODS: Multicenter, randomized, double-blind, placebo-controlled clinical trial with parallel groups. The main outcome measure is intraoperative and postoperative transfusion requirements; blood loss and safety will also be evaluated. Previous results in other types of surgery suggest that tranexamic acid reduces transfusion requirements and blood loss. Hence, the hypothesis of this study is that tranexamic acid will significantly reduce blood loss in comparison to a placebo in major spine surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tranexamic acid | Experimental | Drug: Tranexamic Acidtranexamic acid will be administered as a bolus (10-mg/kg dose ) or as a fast, 20-minute intravenous infusion before performing the incision at the start of surgery, followed by perfusion of 2 mg/kg/hour up to the time the surgical wound is closed at completion of surgery |
| placebo | Placebo comparator | Drug: fisiologic serumThe placebo will be administered according to the same regimen and infusion time as the medication in the study arm (bolus or 20-minute fast infusion before the incision at the beginning of surgery followed by perfusion of 2 mg/kg/hour until closure of the surgical wound at completion of surgery) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients ≥18 years old of both sexes
- scheduled for complex spine surgery
- ASA I-III
- weighing more than 30 kg
- body mass index <30 kg/m2
Key exclusion criteria (11 listed)
- a history of allergy or hypersensitivity to the agent used
- receiving medication that can interfere with coagulation (acetylsalicylic acid, oral anticoagulants, or antiplatelet agents)
- a history of frequent bleeding
- plasma creatinine values >1.5 mg/dL in the baseline analysis
- platelet count less than 150,000/mm3 in the follow-up analysis
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 AcidA 10-mg/kg dose of tranexamic acid will be administered as a bolus or as a fast, 20-minute intravenous infusion before performing the incision at the start of surgery, followed by perfusion of 2 mg/kg/hour up to the time the surgical wound is closed at completion of surgery. | Drug | tranexamic acid |
| fisiologic serumThe placebo will be administered according to the same regimen and infusion time as the medication in the study arm (bolus or 20-minute fast infusion before the incision at the beginning of surgery followed by perfusion of 2 mg/kg/hour until closure of the surgical wound at completion of surgery) | Drug | placebo |
Primary outcome
The primary outcome measure is the number of transfused units required during the intraoperative and postoperative period
Time frame: 7 days postoperative period
2 secondary outcomes
Total blood loss: intraoperative and postoperative values
Time frame: 48 hours postoperative
Adverse events in the perioperative period, immediate postoperative period, and at mid-term
Time frame: up to 6 weeks after the procedure
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 24 Feb 2015.
- Derived from this study: PubMed 28203735Colomina MJ, Koo M, Basora M, Pizones J, Mora L, Bago J. Intraoperative tranexamic acid use in major spine surgery in adults: a multicentre, randomized, placebo-controlled trialdagger. Br J Anaesth. 2017 Mar 1;118(3):380-390. doi: 10.1093/bja/aew434.
Related trials for Spinal Fusion
RecruitingObservational study
OssDsign® Spine Registry Study ("Propel")
Degenerative Disc Disease, Spinal Stenosis
Enrolling by invitationPhase 4
Comparing Outcomes in Patients Who Have Spinal Surgery Who Have No-Ice Cold and Compression Therapy Using the NICE1 Device Versus Standard of Care
Spinal Surgery, Spinal Fusion
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
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.
Maria J Colomina, MD Ph study chair
Hospital Vall d'Hebron
Misericordia Basora, MD Ph principal investigator
Hospital Clinic of Barcelona
Maylin Koo, MD Ph principal investigator
Hospital Universitari de Bellvitge
4 sites 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 fisiologic serum in people with Spinal Fusion and Antifibrinolytic Agents, run by Hospital Universitari Vall d'Hebron Research Institute at 4 sites in Spain.
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 8 inclusion and 11 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 24 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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?
The primary outcome measure is the number of transfused units required during the intraoperative and postoperative period (time frame: 7 days postoperative period). 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 NCT01136590, 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 24 Feb 2015.