Spinal StenosisTARGETSNCT03011866
Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries
A study testing Wound topically irrigated with 500mg TXA and 1mg/kg/hr TXA intravenous infusion till the last suture in people with Spinal Stenosis and Intervertebral Disc Displacement, run by Peking Union Medical College Hospital.
Trial summary
Multilevel decompression and bone graft fusion is a most effective measure for treating degenerative lumbar spinal diseases. Yet, the surgery is commonly associated with large amount of perioperative blood loss and high demand for homologous blood transfusion. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Spinal Stenosis, Intervertebral Disc Displacement
- What is being tested?
- Wound topically irrigated with 500mg TXA and 1mg/kg/hr TXA intravenous infusion till the last suture
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to Dec 2018
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists(ASA)classification of physical status I-II.
- Aged over 50yrs.
- Patients suffering from spinal stenosis or intervertebral disc displacement and require multilevel decompression and bone graft fusion surgeries.
- Written informed consent.
Who cannot join
- ASA III-IV.
- Age≤ 50yrs.
- History of chronic renal dysfunction (preoperative blood creatinine> 120mmol/L), liver dysfunction (preoperative blood aspartate or alanine aminotransferase> 50 units/L) or history of coronary artery disease with stent placement.
- Abnormal preoperative coagulation profile (preoperative prothrombin time elongation> 3s, activated partial thromboplastin time elongation> 10s, platelet counts< 100*10^9/L or >400*10^9/L, or INR> 1.4).
- Pre-existing anemia (male< 12g/dL, female<11g/dL).
- Long-term medications of aspirin and/or other anticoagulants.
Show all 10Show fewer
- Patients known as allergic to TXA.
- Patients who have religious and/or other beliefs limiting blood transfusion.
- Dura mater laceration and/or unexpected massive bleeding during operation.
- Cell saver application during operation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Intravenous Versus Topical Use of Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries (TARGETS) : A Prospective, Randomized, Double Blind, Head-to-head Comparison Study
Multilevel decompression and bone graft fusion is a most effective measure for treating degenerative lumbar spinal diseases. Yet, the surgery is commonly associated with large amount of perioperative blood loss and high demand for homologous blood transfusion. Tranexamic acid (TXA) has been proved as efficient in reducing the gross blood loss in various kinds of surgeries. However, high quality evidence of its efficacy and safety is still lacking in lumbar spinal surgeries. Besides, systemic use of TXA carries the risks of thromboembolic complications such as deep venous thrombosis and pulmonary embolism, thus the optimal drug delivery route of TXA remains undetermined. The aim of this study is to test the non-inferiority of topical TXA application to its intravenous use in multilevel decompression and bone graft fusion surgeries. A prospective, randomized, double-blind, head-to-head comparison study design will be adopted.
- Conditions
- Spinal Stenosis, Intervertebral Disc Displacement
- Being tested
- Wound topically irrigated with 500mg TXA, 1mg/kg/hr TXA intravenous infusion till the last suture
- Medical subject headings
- Spinal Stenosis, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound topically irrigated with 500mg TXADrug
1mg/kg/hr TXA intravenous infusion till the last sutureDrug
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Loading dose: 100ml 0.9% normal saline(NS) intravenous infusion, 15-20min prior to operation initiation.
Maintenance dose: 5ml/hr 0.9% NS intravenous infusion till the last suture. Bolus dose: the wound topically irrigated with 500mg TXA in 250ml 0.9% NS for 5min. Waste fluid was then removed by suction, and the wound was closed. Receives: Drug: Wound topically irrigated with 500mg TXA |
| Control | Other | Loading dose: 10mg/kg tranexamic acid(TXA) in 100ml 0.9% NS intravenous infusion, 15-20min prior to operation initiation.
Maintenance dose: 1mg/kg/hr TXA intravenous infusion till the last suture. Bolus dose: the wound topically irrigated with 250ml 0.9% NS for 5min. Waste fluid was then removed by suction, and the wound was closed. Receives: Drug: 1mg/kg/hr TXA intravenous infusion till the last suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Total blood loss (TBL)
TBL= PBV*（hematocrit on postoperative day 3- preoperative hematocrit）/average hematocrit; Predicted blood volume(PBV)= k1* height^3(m)+ k2* weight(kg)+ k3 (female: k1=0.3561， k2=0.03308， k3=0.1833, male: k1=0.3669， k2=0.03219， k3=0.6041)
Measured: Since operation initiation till postoperative day 3 (POD3)
Secondary outcomes (19)
Visible intraoperative blood loss
Measured: Since operation initiation till operation completion, an average of 120min
Visible postoperative blood loss within 24hrs
Measured: 0- 24hrs postoperatively
Visible postoperative blood loss within 48hrs
Measured: 0- 48hrs postoperatively
Combined visible perioperative blood loss
Combined visible perioperative blood loss= visible intraoperative blood loss + visible postoperative blood loss within 24hrs + visible postoperative blood loss within 48hrs
Measured: Since operation initiation till postoperative 48hrs
Total postoperative blood loss
Total postoperative blood loss= drainage day1(ml)* drainage Hct day1(%)/blood Hct day1(%)+ drainage day2(ml)* drainage Hct day2(%)/blood Hct day2(%)
Measured: 0- 48hrs postoperatively
Postoperative hidden blood loss (HBL)
HBL=TBL- combined visible perioperative blood loss
Measured: 48hrs postoperatively
Postoperative prothrombin time(PT)
Measured: Tested at operation completion, postoperative 24hrs and postoperative 48hrs
Postoperative activated partial thromboplastin time(APTT)
Measured: Tested at operation completion, postoperative 24hrs and postoperative 48hrs
Postoperative fibrinogen level(Fbg)
Measured: Tested at operation completion, postoperative 24hrs and postoperative 48hrs
Postoperative international normalized ratio(INR)
Measured: Tested at operation completion, postoperative 24hrs and postoperative 48hrs
Postoperative R time
Measured: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
Postoperative K time
Measured: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
Postoperative maximum amplitude (MA)
Measured: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
Postoperative lysis after 30 minutes(LY 30)
Measured: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
Postoperative hemoglobin nadir
Measured: Since operation completion till postoperative 48hrs
Perioperative transfusion rates
Measured: Since operation initiation till postoperative 48hrs
Perioperative transfusion amounts
Measured: Since operation initiation till postoperative 48hrs
Length of hospital stay
Length of hospital stay is calculated by subtracting day of admission from day of discharge.
Measured: A single inpatient duration since the day of admission till the day of discharge, an average of 1 week
Adverse event rates
Adverse events include deep venous thrombosis, myocardial infarction, pulmonary embolism, cerebrovascular disease, impaired liver function, impaired renal function and incisional hematoma/ infection.
Measured: Since operation initiation till postoperative 48hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startFeb 2017
- Primary completionDec 2018 (estimated)
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 StenosisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shugang Li, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011866
- Sponsor's protocol ID
- PUMCH-000391
- Acronym
- TARGETS
- Status last verified
- Jan 2017
- First submitted
- 16 Dec 2016
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hui S, Tao L, Mahmood F, Xu D, Ren Z, Chen X, Sheng L, Zhuang Q, Li S, Huang Y. Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries (TARGETS): study protocol for a prospective, randomized, double-blind, non-inferiority trial. Trials. 2019 Feb 12;20(1):125. doi: 10.1186/s13063-019-3231-9.
PubMed 30755256
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Versus Topical Use of Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries (TARGETS) : A Prospective, Randomized, Double Blind, Head-to-head Comparison Study
- ClinicalTrials.gov ID
- NCT03011866
- Acronym / sponsor ID
- TARGETS / PUMCH-000391
- Conditions
- Spinal Stenosis, Intervertebral Disc Displacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Feb 2017
- Primary completion
- Dec 2018 (estimated)
- First posted
- 5 Jan 2017 (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.
Multilevel decompression and bone graft fusion is a most effective measure for treating degenerative lumbar spinal diseases. Yet, the surgery is commonly associated with large amount of perioperative blood loss and high demand for homologous blood transfusion. Tranexamic acid (TXA) has been proved as efficient in reducing the gross blood loss in various kinds of surgeries. However, high quality evidence of its efficacy and safety is still lacking in lumbar spinal surgeries. Besides, systemic use of TXA carries the risks of thromboembolic complications such as deep venous thrombosis and pulmonary embolism, thus the optimal drug delivery route of TXA remains undetermined. The aim of this study is to test the non-inferiority of topical TXA application to its intravenous use in multilevel decompression and bone graft fusion surgeries. A prospective, randomized, double-blind, head-to-head comparison study design will be adopted.
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 |
|---|---|---|
| Experimental | Experimental | Drug: Wound topically irrigated with 500mg TXALoading dose: 100ml 0.9% normal saline(NS) intravenous infusion, 15-20min prior to operation initiation. Maintenance dose: 5ml/hr 0.9% NS intravenous infusion till the last suture. Bolus dose: the wound topically irrigated with 500mg TXA in 250ml 0.9% NS for 5min. Waste fluid was then removed by suction, and the wound was closed. |
| Control | Other | Drug: 1mg/kg/hr TXA intravenous infusion till the last sutureLoading dose: 10mg/kg tranexamic acid(TXA) in 100ml 0.9% NS intravenous infusion, 15-20min prior to operation initiation. Maintenance dose: 1mg/kg/hr TXA intravenous infusion till the last suture. Bolus dose: the wound topically irrigated with 250ml 0.9% NS for 5min. Waste fluid was then removed by suction, and the wound was closed. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists(ASA)classification of physical status I-II.
- Aged over 50yrs.
- Patients suffering from spinal stenosis or intervertebral disc displacement and require multilevel decompression and bone graft fusion surgeries.
- Written informed consent.
Key exclusion criteria (10 listed)
- ASA III-IV.
- Age≤ 50yrs.
- History of chronic renal dysfunction (preoperative blood creatinine> 120mmol/L), liver dysfunction (preoperative blood aspartate or alanine aminotransferase> 50 units/L) or history of coronary artery disease with stent placement.
- Abnormal preoperative coagulation profile (preoperative prothrombin time elongation> 3s, activated partial thromboplastin time elongation> 10s, platelet counts< 100*10^9/L or >400*10^9/L, or INR> 1.4).
- Pre-existing anemia (male< 12g/dL, female<11g/dL).
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 |
|---|---|---|
| Wound topically irrigated with 500mg TXA | Drug | Experimental |
| 1mg/kg/hr TXA intravenous infusion till the last suture | Drug | Control |
Primary outcome
Perioperative Total blood loss (TBL)
Time frame: Since operation initiation till postoperative day 3 (POD3)
TBL= PBV*（hematocrit on postoperative day 3- preoperative hematocrit）/average hematocrit; Predicted blood volume(PBV)= k1* height^3(m)+ k2* weight(kg)+ k3 (female: k1=0.3561， k2=0.03308， k3=0.1833, male: k1=0.3669， k2=0.03219， k3=0.6041)
19 secondary outcomes
Visible intraoperative blood loss
Time frame: Since operation initiation till operation completion, an average of 120min
Visible postoperative blood loss within 24hrs
Time frame: 0- 24hrs postoperatively
Visible postoperative blood loss within 48hrs
Time frame: 0- 48hrs postoperatively
Combined visible perioperative blood loss
Time frame: Since operation initiation till postoperative 48hrs
Total postoperative blood loss
Time frame: 0- 48hrs postoperatively
Postoperative hidden blood loss (HBL)
Time frame: 48hrs postoperatively
Postoperative prothrombin time(PT)
Time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs
Postoperative activated partial thromboplastin time(APTT)
Time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs
Postoperative fibrinogen level(Fbg)
Time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs
Postoperative international normalized ratio(INR)
Time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs
Postoperative R time
Time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
Postoperative K time
Time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
Postoperative maximum amplitude (MA)
Time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
Postoperative lysis after 30 minutes(LY 30)
Time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
Postoperative hemoglobin nadir
Time frame: Since operation completion till postoperative 48hrs
Perioperative transfusion rates
Time frame: Since operation initiation till postoperative 48hrs
Perioperative transfusion amounts
Time frame: Since operation initiation till postoperative 48hrs
Length of hospital stay
Time frame: A single inpatient duration since the day of admission till the day of discharge, an average of 1 week
Adverse event rates
Time frame: Since operation initiation till postoperative 48hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
- Derived from this study: PubMed 30755256Hui S, Tao L, Mahmood F, Xu D, Ren Z, Chen X, Sheng L, Zhuang Q, Li S, Huang Y. Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries (TARGETS): study protocol for a prospective, randomized, double-blind, non-inferiority trial. Trials. 2019 Feb 12;20(1):125. doi: 10.1186/s13063-019-3231-9.
Related trials for Spinal Stenosis
Not yet recruitingObservational study
Foraminal Imaging and Symptoms in Single-Level Degenerative Lumbar Stenosis
Degenerative Lumbar Spinal Stenosis, Lumbar Foraminal Stenosis
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Lumbar Spinal Stenosis
Active, not recruitingPhase 3
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Melanoma, Ovarian Cancer
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
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.
Questions about this trial
What is this clinical trial studying?
A study testing Wound topically irrigated with 500mg TXA and 1mg/kg/hr TXA intravenous infusion till the last suture in people with Spinal Stenosis and Intervertebral Disc Displacement, run by Peking Union Medical College Hospital.
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: status not confirmed, as of the sponsor's last update on 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qianyu Zhuang, M.D. (86-13552869326, zhuangqianyu@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Total blood loss (TBL) (time frame: Since operation initiation till postoperative day 3 (POD3)). 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 NCT03011866, 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 5 Jan 2017.