Total Hip ArthroplastyNCT03157401
Two Different Administration Methods of Tranexamic Acid on Perioperative Blood Loss During Total Hip Arthroplasty
An observational study of Total Hip Arthroplasty, run by Tengzhou Central People's Hospital.
Trial summary
To compare the two administration methods of tranexamic acid for patients undergoing the first unilateral THA, to explore the effects of tranexamic acid on perioperative blood loss from the aspects of dominant blood loss, hidden blood loss, blood transfusion rate, mean blood transfusion volume and safety so as to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- intravenous infusion group and intra-articular injection group
- Type of treatment
- Injection or infusion
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Dec 2017
- Phase
- Observational
- 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
Study population: To recruit 90 patients undergoing the first unilateral THA at the Tengzhou Central People's Hospital from July 2015 to November 2016. The patients were equally and randomly assigned to three groups.
Who may be able to join
- Femoral head necrosis or femoral neck fracture patients undergoing the first unilateral THA
- Bilateral hips with indications for THA in patients with femoral head necrosis, but after arthroplasty on one side, the arthroplasty on the other side will be conducted when choosing a good time and physical condition allows.
- Average age: 62.52 years
- Sex ratio of males to females: 11:19
- Signed informed consent
Who cannot join
- Coagulation disorders and anemia
- History of infection on the affected extremity
- History of vascular embolization and long-term oral anticoagulant drugs
- Contraindications for tranexamic acid or anticoagulant drugs
About this study
Official title: Effects of Two Different Administration Methods of Tranexamic Acid on Perioperative Blood Loss During Total Hip Arthroplasty: a Prospective, Open-label, Randomized, Controlled Clinical Trial
To compare the two administration methods of tranexamic acid for patients undergoing the first unilateral THA, to explore the effects of tranexamic acid on perioperative blood loss from the aspects of dominant blood loss, hidden blood loss, blood transfusion rate, mean blood transfusion volume and safety so as to further clarify what kind of medication is more effective.
Read the detailed description
Background Total hip arthroplasty (THA) is extensively used in various hip diseases. Abundant blood supply at surgical area of bone tissue, intraoperative extensive cleaning, acetabular formation, femoral expansion, and medullary cavity and bone wound bleeding, will lead to extensive intraoperative and postoperative blood loss. The blood transfusion rate is high, which affects patients' rehabilitation. Previous studies have shown that 16%-69% patients required blood transfusion after first THA, which greatly affected patient's rehabilitation, and increased the risk of transfusion-related infection, hemolysis, immunosuppression, acute lung injury, and death. How to reduce perioperative blood loss in total hip arthroplasty has become a hot spot for joint surgeons.
Tranexamic acid as a synthetic antifibrinolytic drug is a synthetic analog of the amino acid lysine. Its mechanisms of action are the competitive inhibition of fibrinolytic zymogens, and noncompetitive inhibition of fibrinolytic enzymes. Tranexamic acid strongly inhibits plasmin-induced fibrin decomposition, reduces fibrinolytic system activity, to achieve local hemostasis and reduce bleeding (Appendix 1). However, the route of administration of tranexamic acid is diverse, and the best way to administer is not clear. A large number of studies have confirmed that during total knee arthroplasty and THA, intravenous application of tranexamic acid can significantly reduce postoperative blood loss, blood transfusion volume and blood transfusion rate. Intra-articular application of tranexamic acid can reduce the drainage volume of drainage tube, total blood loss, blood transfusion volume and blood transfusion rate after joint arthroplasty. Moreover, hemoglobin levels remarkably increase after surgery. More and more studies and meta-analysis have verified that tranexamic acid has a "target effect". Reasonable use of tranexamic acid does not increase the risk of deep venous thrombosis or pulmonary embolism after hip and knee arthroplasties. Simultaneously, tranexamic acid has a good potency ratio.
Adverse events
- To record adverse events during follow up, including incision pain, infection, hip pain, peripheral nerve injury, pulmonary embolism, lower extremity hematoma, deep vein thrombosis, and fixator falling off.
- If severe adverse events occur, investigators would report details, including the date of occurrence and measures taken to treat the adverse events, to the principle investigator and the institutional review board within 24 hours.
Data collection, management, analysis, open access
- Data collection: Case report forms were collected and processed using Epidata software (Epidata Association, Odense, Denmark). These data would be recorded electronically.
- Data management: Tengzhou Central People's Hospital, China would preserve all of the data regarding this trial. Only the project manager has the right to query the database file. This arrangement will not be altered.
- Data analysis: A professional statistician would statistically analyze the electronic database and create an outcome analysis report. An independent data monitoring committee would supervise and manage the trial data.
- Data open access: Anonymized trial data will be published at www.figshare.com.
Statistical analysis
- Statistical analysis would be performed using SPSS 19.0 software (IBM, Armonk, NY, USA) and would follow the intention-to-treat principle.
- Normally distributed measurement data would be expressed as means ± standard deviation and minimums and maximums. Non-normally distributed measurement data would be expressed as the lower quartile (q1) and median and upper quartiles (q3). Count data would be expressed as a percentage.
- The differences in hidden blood loss, dominant blood loss and mean blood loss in each group at intraoperative, postoperative 1 and 3 days would be compared using two-factor analysis of variance with repeated measures. Paired comparison of intergroup data would be conducted using least significant difference. Blood transfusion rate and incidence of adverse reactions in each group were compared using Pearson X2 test.
- The significance level would be α = 0.05.
- Conditions
- Total Hip Arthroplasty
- Being tested
- intravenous infusion group, intra-articular injection group, control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous infusion groupDrug
Also called tranexamic acid intravenous infusion group
In the tranexamic acid intravenous infusion group (n = 30), 15 mg/kg tranexamic acid diluted in 100 mL physiological saline was intravenously infused at the beginning of the surgery. After suturing deep fascia, 20 mL of physiological saline was intra-articularly injected.
intra-articular injection groupDrug
Also called tranexamic acid intra-articular injection group
In the tranexamic acid intra-articular injection group (n = 30), 100 mL of physiological saline was intravenously infused at the beginning of the surgery. After suturing deep fascia, the mixture of 1.5 g tranexamic acid and 20 mL physiological saline was intra-articularly injected.
control groupDrug
Also called physiological saline group
In the control group (n = 30), 100 mL of physiological saline was intravenously infused at the beginning of the surgery. After suturing deep fascia, 20 mL of physiological saline was intra-articularly injected.
| Study group | Role | What they receive |
|---|---|---|
| intravenous infusion group | In the tranexamic acid intravenous infusion group (n = 30), 15 mg/kg tranexamic acid diluted in 100 mL physiological saline was intravenously infused at the beginning of the surgery. After suturing deep fascia, 20 mL of physiological saline was intra-articularly injected. Receives: Drug: intravenous infusion group | |
| intra-articular injection group | In the tranexamic acid intra-articular injection group (n = 30), 100 mL of physiological saline was intravenously infused at the beginning of the surgery. After suturing deep fascia, the mixture of 1.5 g tranexamic acid and 20 mL physiological saline was intra-articularly injected. Receives: Drug: intra-articular injection group | |
| control group | In the control group (n = 30), 100 mL of physiological saline was intravenously infused at the beginning of the surgery. After suturing deep fascia, 20 mL of physiological saline was intra-articularly injected. Receives: Drug: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
hidden blood loss
Hidden blood loss was calculated by the circulation volume proposed by Gross, i.e., total erythrocyte loss is equal to preoperative total blood volume × (hematocrit preoperatively - hematocrit postoperatively 3 days).
Measured: at postoperative 1 and 3 days
Secondary outcomes (1)
Dominant blood loss
Dominant blood loss includes intraoperative blood loss and postoperative blood loss. Intraoperative blood loss was quantified by measuring irrigation fluid and weight measurement of surgical sponges. Postoperative blood loss was quantified by measuring wound drainage volume and weight measurement of surgical sponges.
Measured: at intraoperative, postoperative 1 and 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study startApr 2015
- Primary completionNov 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tengzhou Central People's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, neonatal intensive care unit, Tengzhou Central People's Hospital
- Investigators
- Zhenyang Hou, Master, Principal investigator, Tengzhou Central People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157401
- Sponsor's protocol ID
- TengzhouCPH_01
- Status last verified
- Feb 2018
- First submitted
- 15 May 2017
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Different Administration Methods of Tranexamic Acid on Perioperative Blood Loss During Total Hip Arthroplasty: a Prospective, Open-label, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03157401
- Acronym / sponsor ID
- TengzhouCPH_01
- Conditions
- Total Hip Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tengzhou Central People's HospitalOther government
- Study start
- Apr 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 17 May 2017 (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.
To compare the two administration methods of tranexamic acid for patients undergoing the first unilateral THA, to explore the effects of tranexamic acid on perioperative blood loss from the aspects of dominant blood loss, hidden blood loss, blood transfusion rate, mean blood transfusion volume and safety so as to further clarify what kind of medication is more effective.
Detailed description
Background Total hip arthroplasty (THA) is extensively used in various hip diseases. Abundant blood supply at surgical area of bone tissue, intraoperative extensive cleaning, acetabular formation, femoral expansion, and medullary cavity and bone wound bleeding, will lead to extensive intraoperative and postoperative blood loss. The blood transfusion rate is high, which affects patients' rehabilitation. Previous studies have shown that 16%-69% patients required blood transfusion after first THA, which greatly affected patient's rehabilitation, and increased the risk of transfusion-related infection, hemolysis, immunosuppression, acute lung injury, and death. How to reduce perioperative blood loss in total hip arthroplasty has become a hot spot for joint surgeons.
Tranexamic acid as a synthetic antifibrinolytic drug is a synthetic analog of the amino acid lysine. Its mechanisms of action are the competitive inhibition of fibrinolytic zymogens, and noncompetitive inhibition of fibrinolytic enzymes. Tranexamic acid strongly inhibits plasmin-induced fibrin decomposition, reduces fibrinolytic system activity, to achieve local hemostasis and reduce bleeding (Appendix 1). However, the route of administration of tranexamic acid is diverse, and the best way to administer is not clear. A large number of studies have confirmed that during total knee arthroplasty and THA, intravenous application of tranexamic acid can significantly reduce postoperative blood loss, blood transfusion volume and blood transfusion rate. Intra-articular application of tranexamic acid can reduce the drainage volume of drainage tube, total blood loss, blood transfusion volume and blood transfusion rate after joint arthroplasty. Moreover, hemoglobin levels remarkably increase after surgery. More and more studies and meta-analysis have verified that tranexamic acid has a "target effect". Reasonable use of tranexamic acid does not increase the risk of deep venous thrombosis or pulmonary embolism after hip and knee arthroplasties. Simultaneously, tranexamic acid has a good potency ratio.
Adverse events
- To record adverse events during follow up, including incision pain, infection, hip pain, peripheral nerve injury, pulmonary embolism, lower extremity hematoma, deep vein thrombosis, and fixator falling off.
- If severe adverse events occur, investigators would report details, including the date of occurrence and measures taken to treat the adverse events, to the principle investigator and the institutional review board within 24 hours.
Data collection, management, analysis, open access
- Data collection: Case report forms were collected and processed using Epidata software (Epidata Association, Odense, Denmark). These data would be recorded electronically.
- Data management: Tengzhou Central People's Hospital, China would preserve all of the data regarding this trial. Only the project manager has the right to query the database file. This arrangement will not be altered.
- Data analysis: A professional statistician would statistically analyze the electronic database and create an outcome analysis report. An independent data monitoring committee would supervise and manage the trial data.
- Data open access: Anonymized trial data will be published at www.figshare.com.
Statistical analysis
- Statistical analysis would be performed using SPSS 19.0 software (IBM, Armonk, NY, USA) and would follow the intention-to-treat principle.
- Normally distributed measurement data would be expressed as means ± standard deviation and minimums and maximums. Non-normally distributed measurement data would be expressed as the lower quartile (q1) and median and upper quartiles (q3). Count data would be expressed as a percentage.
- The differences in hidden blood loss, dominant blood loss and mean blood loss in each group at intraoperative, postoperative 1 and 3 days would be compared using two-factor analysis of variance with repeated measures. Paired comparison of intergroup data would be conducted using least significant difference. Blood transfusion rate and incidence of adverse reactions in each group were compared using Pearson X2 test.
- The significance level would be α = 0.05.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intravenous infusion group | – | Drug: intravenous infusion groupIn the tranexamic acid intravenous infusion group (n = 30), 15 mg/kg tranexamic acid diluted in 100 mL physiological saline was intravenously infused at the beginning of the surgery. After suturing deep fascia, 20 mL of physiological saline was intra-articularly injected. |
| intra-articular injection group | – | Drug: intra-articular injection groupIn the tranexamic acid intra-articular injection group (n = 30), 100 mL of physiological saline was intravenously infused at the beginning of the surgery. After suturing deep fascia, the mixture of 1.5 g tranexamic acid and 20 mL physiological saline was intra-articularly injected. |
| control group | – | Drug: control groupIn the control group (n = 30), 100 mL of physiological saline was intravenously infused at the beginning of the surgery. After suturing deep fascia, 20 mL of physiological saline was intra-articularly injected. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- To recruit 90 patients undergoing the first unilateral THA at the Tengzhou Central People's Hospital from July 2015 to November 2016. The patients were equally and randomly assigned to three groups.
Key inclusion criteria (5 listed)
- Femoral head necrosis or femoral neck fracture patients undergoing the first unilateral THA
- Bilateral hips with indications for THA in patients with femoral head necrosis, but after arthroplasty on one side, the arthroplasty on the other side will be conducted when choosing a good time and physical condition allows.
- Average age: 62.52 years
- Sex ratio of males to females: 11:19
- Signed informed consent
Key exclusion criteria (4 listed)
- Coagulation disorders and anemia
- History of infection on the affected extremity
- History of vascular embolization and long-term oral anticoagulant drugs
- Contraindications for tranexamic acid or anticoagulant drugs
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 |
|---|---|---|
| intravenous infusion groupAlso: tranexamic acid intravenous infusion groupIn the tranexamic acid intravenous infusion group (n = 30), 15 mg/kg tranexamic acid diluted in 100 mL physiological saline was intravenously infused at the beginning of the surgery. After suturing deep fascia, 20 mL of physiological saline was intra-articularly injected. | Drug | intravenous infusion group |
| intra-articular injection groupAlso: tranexamic acid intra-articular injection groupIn the tranexamic acid intra-articular injection group (n = 30), 100 mL of physiological saline was intravenously infused at the beginning of the surgery. After suturing deep fascia, the mixture of 1.5 g tranexamic acid and 20 mL physiological saline was intra-articularly injected. | Drug | intra-articular injection group |
| control groupAlso: physiological saline groupIn the control group (n = 30), 100 mL of physiological saline was intravenously infused at the beginning of the surgery. After suturing deep fascia, 20 mL of physiological saline was intra-articularly injected. | Drug | control group |
Primary outcome
hidden blood loss
Time frame: at postoperative 1 and 3 days
Hidden blood loss was calculated by the circulation volume proposed by Gross, i.e., total erythrocyte loss is equal to preoperative total blood volume × (hematocrit preoperatively - hematocrit postoperatively 3 days).
1 secondary outcome
Dominant blood loss
Time frame: at intraoperative, postoperative 1 and 3 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 9 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
Zhenyang Hou, Master principal investigator
Tengzhou Central People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Arthroplasty, run by Tengzhou Central People's 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 5 inclusion and 4 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 9 Feb 2018. 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?
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?
hidden blood loss (time frame: at postoperative 1 and 3 days). 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 9 Feb 2018.