Total Blood LossPhase 3NCT02393300
Comparison of Topical Versus Intravenous Tranexamic Acid in TKA
A Phase 3 study testing normal saline and Tranexamic Acid in people with Total Blood Loss, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Previous studies in both the cardiovascular and orthopedic study have shown tranexamic acid (TXA) reduces blood loss and post-operative blood transfusion rate largely without major complications . In addition, many meta-analyses have confirmed these results . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Blood Loss
- What is being tested?
- normal saline and Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Oct 2015
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consented to join in our project.
- Adult patients (greater than 18 years old)
- Patients scheduled for primary unilateral knee arthroplasty
Who cannot join
- Patients who refuse to sign the Inform Consent
- Had an allergy to TXA.
- Using anticoagulant drugs within a week.
- Coagulopathy (preoperative platelet count <150,000/mm3,International Sensitivity Index（INR）>1.4, prolonged Activated Partial Thromboplastin Time，Prothrombin Time ，or thrombin time >1.4 times longer than normal.
- Breastfeeding
- Major comorbidities: Severe ischemic heart disease(class III and IV of New York Heart Association); sleep apnea syndrome; renal dysfunction ( glomerular filtration rate<60); or hepatic disfunction(glutamic-pyruvic transaminase>80 or glutamic oxalacetic transaminase>80).Retinopathy (disturbances of color vision).
- 9.History of thromboembolic disease
Trial locations and contacts
1 site in 1 country.
China1 site
Orthopedic Department of Ruijin hospital
Shanghai, Shanghai Municipality, 200001
About this study
Official title: Comparison of Topical Versus Intravenous Tranexamic Acid in Primary Total Knee Arthroplasty：A Prospective Randomized Study
Previous studies in both the cardiovascular and orthopedic study have shown tranexamic acid (TXA) reduces blood loss and post-operative blood transfusion rate largely without major complications . In addition, many meta-analyses have confirmed these results . However, there is little information about comparison among the different routes of TXA administration in TKA. Therefore, this study has been designed to determine which administration route of TXA is more effective and safety.
Read the detailed description
Objectives:To assess the efficacy and safety between the two different applying routes.
Patients in this project will be randomly divided into three groups , one group is a blank group and the rest two receive either the topical or the intravenous form of tranexamic acid during unilateral TKA(total knee arthroplasty).The total blood loss(TBL) will be calculated as the primary outcome for efficacy while Deep Vein Thrombosis、Pulmonary Embolism、Acute Myocardial Infarction 、 Acute Kidney Infarction and Cerebral Infarction events will be recorded to assess the safety of the tranexamic acid during a six-week follow-up for each patient.
All surgery are under general anesthesia, through direct lateral approach with cementless prosthesis.For all patients, the drain tube will be clamped and closed completely for 2 hours; then the clamp will be fully opened.
- Conditions
- Total Blood Loss
- Being tested
- normal saline, Tranexamic Acid
- Keywords
- tranexamic acid, blood loss, topical administration, intravenous administration
- Medical subject headings
- Exsanguination, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal salineDrug
Also called 0.9% sodium chloride
The normal saline solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the scrub nurse. The contents (60 ml) will be emptied in a sterile surgical bowl and the nurse will ask the surgeon to apply the solution before wound closure.The dosage and applying route can also be looked up in doctor's order sheet.
Tranexamic AcidDrug
Also called Cyclokapron
The Tranexamic Acid solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the scrub nurse. The contents (60 ml) will be emptied in a sterile surgical bowl and the nurse will ask the surgeon to apply the solution before wound closure.The dosage and applying route can also be looked up in doctor's order sheet.
Tranexamic AcidDrug
Also called Cyclokapron
The Tranexamic Acid solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the circuit nurse and the circuit nurse will ask the anesthetist to apply the solution intravenously before tourniquet deflation. The dosage and applying route can also be looked up in doctor's order sheet.
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Placebo comparator | 60 Milliliters（ml）Normal saline (0.9% sodium chloride) will be applied by soaking the knee cavity for at least 3 minutes before wound closure and then sucked away. Receives: Drug: normal saline |
| Group2 | Experimental | two-dose intravenous tranexamic acid will be applied as follow: 10mg/kg of Tranexamic Acid in 100 Milliliters（ml) normal saline (0.9% sodium chloride),the first dose 15' before the tourniquet deflation and the second dose at 180' after the first dosage Receives: Drug: Tranexamic Acid |
| Group 3 | Experimental | 3g Tranexamic Acid diluted to 60 Milliliters（ml） with normal saline (0.9% sodium chloride) will be applied by soaking the knee cavity for at least 3 minutes before wound closure and then sucked away. Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Blood Loss（TBL）
Total Blood Loss（TBL） was calculated with equations described by Gross et al.
Measured: calculated by an equation at the fifth postoperative day
Secondary outcomes (1)
Transfusion rates
Include The number of units of perioperative blood transfusions, both intraoperative and postoperative, over the course of the patient's hospital stay
Measured: from the day of surgery to the day of discharge,an expected average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startJul 2014
- Primary completionMay 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Blood LossStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhoukaidi, Shanghai Jiao Tong University School of Medicine
- Investigators
- jianmin feng, master, Principal investigator, ruijin hospital，shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393300
- Sponsor's protocol ID
- JTU-GK-011
- Status last verified
- Nov 2015
- First submitted
- 15 Mar 2015
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Topical Versus Intravenous Tranexamic Acid in Primary Total Knee Arthroplasty：A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02393300
- Acronym / sponsor ID
- JTU-GK-011
- Conditions
- Total Blood Loss
- Keywords
- tranexamic acid, blood loss, topical administration, intravenous administration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 19 Mar 2015 (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.
Previous studies in both the cardiovascular and orthopedic study have shown tranexamic acid (TXA) reduces blood loss and post-operative blood transfusion rate largely without major complications . In addition, many meta-analyses have confirmed these results . However, there is little information about comparison among the different routes of TXA administration in TKA. Therefore, this study has been designed to determine which administration route of TXA is more effective and safety.
Detailed description
Objectives:To assess the efficacy and safety between the two different applying routes.
Patients in this project will be randomly divided into three groups , one group is a blank group and the rest two receive either the topical or the intravenous form of tranexamic acid during unilateral TKA(total knee arthroplasty).The total blood loss(TBL) will be calculated as the primary outcome for efficacy while Deep Vein Thrombosis、Pulmonary Embolism、Acute Myocardial Infarction 、 Acute Kidney Infarction and Cerebral Infarction events will be recorded to assess the safety of the tranexamic acid during a six-week follow-up for each patient.
All surgery are under general anesthesia, through direct lateral approach with cementless prosthesis.For all patients, the drain tube will be clamped and closed completely for 2 hours; then the clamp will be fully opened.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group1 | Placebo comparator | Drug: normal saline60 Milliliters（ml）Normal saline (0.9% sodium chloride) will be applied by soaking the knee cavity for at least 3 minutes before wound closure and then sucked away. |
| Group2 | Experimental | Drug: Tranexamic Acidtwo-dose intravenous tranexamic acid will be applied as follow: 10mg/kg of Tranexamic Acid in 100 Milliliters（ml) normal saline (0.9% sodium chloride),the first dose 15' before the tourniquet deflation and the second dose at 180' after the first dosage |
| Group 3 | Experimental | Drug: Tranexamic Acid3g Tranexamic Acid diluted to 60 Milliliters（ml） with normal saline (0.9% sodium chloride) will be applied by soaking the knee cavity for at least 3 minutes before wound closure and then sucked away. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consented to join in our project.
- Adult patients (greater than 18 years old)
- Patients scheduled for primary unilateral knee arthroplasty
Key exclusion criteria (7 listed)
- Patients who refuse to sign the Inform Consent
- Had an allergy to TXA.
- Using anticoagulant drugs within a week.
- Coagulopathy (preoperative platelet count <150,000/mm3,International Sensitivity Index（INR）>1.4, prolonged Activated Partial Thromboplastin Time，Prothrombin Time ，or thrombin time >1.4 times longer than normal.
- Breastfeeding
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 |
|---|---|---|
| normal salineAlso: 0.9% sodium chlorideThe normal saline solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the scrub nurse. The contents (60 ml) will be emptied in a sterile surgical bowl and the nurse will ask the surgeon to apply the solution before wound closure.The dosage and applying route can also be looked up in doctor's order sheet. | Drug | Group1 |
| Tranexamic AcidAlso: CyclokapronThe Tranexamic Acid solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the scrub nurse. The contents (60 ml) will be emptied in a sterile surgical bowl and the nurse will ask the surgeon to apply the solution before wound closure.The dosage and applying route can also be looked up in doctor's order sheet. | Drug | Group 3 |
| Tranexamic AcidAlso: CyclokapronThe Tranexamic Acid solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the circuit nurse and the circuit nurse will ask the anesthetist to apply the solution intravenously before tourniquet deflation. The dosage and applying route can also be looked up in doctor's order sheet. | Drug | Group2 |
Primary outcome
Total Blood Loss（TBL）
Time frame: calculated by an equation at the fifth postoperative day
Total Blood Loss（TBL） was calculated with equations described by Gross et al.
1 secondary outcome
Transfusion rates
Time frame: from the day of surgery to the day of discharge,an expected average of 7 days
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 2018.
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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.
jianmin feng, master principal investigator
ruijin hospital，shanghai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing normal saline and Tranexamic Acid in people with Total Blood Loss, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 7 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 2018. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Total Blood Loss（TBL） (time frame: calculated by an equation at the fifth postoperative day). 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 2018.