Blood LossPhase 3NCT02312440
Comparison of Topical and Intravenous Tranexamic Acid in Total Hip Arthroplasty
A Phase 3 study testing 0.9% sodium chloride and tranexamic acid in people with Blood Loss, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Recently, there has been interest in applying tranexamic acid topically before the closure of surgical wounds in total hip replacement. It has the advantages of ease of application, maximum concentration at the site of bleeding, minimising its systematic absorption and, potentially , decline the risks for systematic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss
- What is being tested?
- 0.9% sodium chloride and tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 173 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Sep 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 hip arthroplasty Patients for Ruijin hospital, Shanghai, China
Who cannot join
- Patients who refuse to sign the Inform Consent
- Had an allergy to TXA.
- long-term bed >=3 weeks.
- Using anticoagulant drugs within a week.
- Coagulopathy (preoperative platelet count <150,000/mm3, INR>1.4, prolonged Activated Partial Thromboplastin Time，Prothrombin Time ，or thrombin time (>1.4 times longer than normal)
- Pregnancy
Show all 10Show fewer
- 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).
- History of thromboembolic disease: .
- Been participating or been participated within a year in another clinical trial
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 and Intravenous Tranexamic Acid on Blood Loss and Transfusion Rates in Total Hip Arthroplasty
Recently, there has been interest in applying tranexamic acid topically before the closure of surgical wounds in total hip replacement. It has the advantages of ease of application, maximum concentration at the site of bleeding, minimising its systematic absorption and, potentially , decline the risks for systematic side-effects 。
Read the detailed description
Objectives:To assess the efficacy and safety between the two different applying routes.
Patients in this project are randomly divided into three groups , one group is a blank group and the rest two groups receive either the topical or the intravenous form of tranexamic acid during unilateral THA(total hip arthroplasty).The total blood loss(TBL) will be calculated as the primary outcome for efficacy while the events of Deep Vein Thrombosis、Pulmonary Embolism、Acute Myocardial Infarction 、 Acute Kidney Infarction and Cerebral Infarction 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 is clamped and closed completely for 2 hours; then the clamp is fully opened.
- Conditions
- Blood Loss
- Being tested
- 0.9% sodium chloride, tranexamic acid
- Keywords
- tranexamic acid, blood loss, topical administration, intravenous administration
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% sodium chlorideDrug
Also called normal saline
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.
60 Milliliters（ml） by irrigation for 3 minutes before wound closure.
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Placebo comparator | 60 Milliliters（ml）Normal saline (0.9% sodium chloride) will be applied by soaking the hip cavity for at least 3 minutes before wound closure and then sucked away. Receives: Drug: 0.9% sodium chloride |
| 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' prior to skin incision 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 hip 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 estimated with equations described by Gross et al.
Measured: estimated by an equation at the fifth postoperative day
Secondary outcomes (4)
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
Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary embolism)
Clinically proven symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE)
Measured: twelve weeks after surgery
other thromboembolic event
Clinically proven Acute Myocardial Infarction 、 acute kidney infarction or cerebral infarction
Measured: twelve weeks after surgery
drainage output
The amount of blood collected by a drain attached to the hip is measured 48 hours after surgery
Measured: ti will be recorded at the first day and the second day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 173 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
- NCT02312440
- Sponsor's protocol ID
- JTU-GK-010
- Status last verified
- May 2015
- First submitted
- 10 Nov 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Topical and Intravenous Tranexamic Acid on Blood Loss and Transfusion Rates in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02312440
- Acronym / sponsor ID
- JTU-GK-010
- Conditions
- Blood Loss
- Keywords
- tranexamic acid, blood loss, topical administration, intravenous administration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 9 Dec 2014 (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.
Recently, there has been interest in applying tranexamic acid topically before the closure of surgical wounds in total hip replacement. It has the advantages of ease of application, maximum concentration at the site of bleeding, minimising its systematic absorption and, potentially , decline the risks for systematic side-effects 。
Detailed description
Objectives:To assess the efficacy and safety between the two different applying routes.
Patients in this project are randomly divided into three groups , one group is a blank group and the rest two groups receive either the topical or the intravenous form of tranexamic acid during unilateral THA(total hip arthroplasty).The total blood loss(TBL) will be calculated as the primary outcome for efficacy while the events of Deep Vein Thrombosis、Pulmonary Embolism、Acute Myocardial Infarction 、 Acute Kidney Infarction and Cerebral Infarction 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 is clamped and closed completely for 2 hours; then the clamp is fully opened.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group1 | Placebo comparator | Drug: 0.9% sodium chloride60 Milliliters（ml）Normal saline (0.9% sodium chloride) will be applied by soaking the hip 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' prior to skin incision 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 hip 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 hip arthroplasty Patients for Ruijin hospital, Shanghai, China
Key exclusion criteria (10 listed)
- Patients who refuse to sign the Inform Consent
- Had an allergy to TXA.
- long-term bed >=3 weeks.
- Using anticoagulant drugs within a week.
- Coagulopathy (preoperative platelet count <150,000/mm3, INR>1.4, prolonged Activated Partial Thromboplastin Time，Prothrombin Time ，or thrombin time (>1.4 times longer than normal)
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 |
|---|---|---|
| 0.9% sodium chlorideAlso: normal salineThe 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 | Group2 |
| 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. 60 Milliliters（ml） by irrigation for 3 minutes before wound closure. | Drug | Group 3 |
Primary outcome
Total Blood Loss（TBL）
Time frame: estimated by an equation at the fifth postoperative day
Total Blood Loss（TBL） was estimated with equations described by Gross et al.
4 secondary outcomes
Transfusion rates
Time frame: from the day of surgery to the day of discharge,an expected average of 7 days
Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary embolism)
Time frame: twelve weeks after surgery
other thromboembolic event
Time frame: twelve weeks after surgery
drainage output
Time frame: ti will be recorded at the first day and the second day after surgery
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 2 Dec 2015.
Related trials for Blood Loss
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
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 0.9% sodium chloride and tranexamic acid in people with 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 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: finished, as of the sponsor's last update on 2 Dec 2015. 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: estimated 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 2 Dec 2015.