Total Hip ArthroplastyNCT07610863
Combined Tranexamic Acid Use in Total Hip Replacement Surgery
A study testing Intravenous Tranexamic Acid and Combined Intravenous and Intraarticular Tranexamic Acid in people with Total Hip Arthroplasty and Tranexamic Acid Administration, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
Trial summary
This prospective study evaluates whether combined intravenous and topical administration of tranexamic acid (TXA) can safely reduce blood loss in patients undergoing primary total hip replacement surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Hip Arthroplasty, Tranexamic Acid Administration, Perioperative Blood Loss
- What is being tested?
- Intravenous Tranexamic Acid and Combined Intravenous and Intraarticular Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2024to 31 Jul 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults undergoing elective primary cementless total hip arthroplasty for primary hip osteoarthritis
- Preoperative hemoglobin level ≥130 g/L
- Ability to provide written informed consent
Who cannot join
- Post-traumatic or secondary hip arthritis
- Known allergy or hypersensitivity to tranexamic acid
- History of deep vein thrombosis or pulmonary embolism
- Current anticoagulant therapy
- Known coagulation disorder
- Body mass index (BMI) >40 kg/m²
Show all 10Show fewer
- Significant hepatic or renal dysfunction
- Type 1 diabetes mellitus
- Significant cardiovascular disease
- Traumatic indication for total hip arthroplasty
Trial locations and contacts
1 site in 1 country.
Czechia1 site
First Department of Orthopaedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia
Brno, Czechia, 60200
About this study
Official title: Combined Intravenous and Topical Tranexamic Acid in Total Hip Arthroplasty: A Prospective Comparative Study With Rotational Thromboelastometry Monitoring
This prospective study evaluates whether combined intravenous and topical administration of tranexamic acid (TXA) can safely reduce blood loss in patients undergoing primary total hip replacement surgery. Tranexamic acid is commonly used during orthopedic surgery to decrease bleeding and reduce the need for blood transfusions.
Participants undergoing elective primary total hip arthroplasty are assigned to receive either intravenous TXA alone or a combination of intravenous and topical TXA applied directly around the hip joint during surgery. The study compares postoperative blood loss, changes in hemoglobin levels, transfusion requirements, length of hospital stay, and postoperative complications between the treatment groups.
The study also uses rotational thromboelastometry (ROTEM), a specialized blood coagulation monitoring method, to evaluate whether combined TXA administration affects blood clotting or increases the risk of thromboembolic complications such as deep vein thrombosis or pulmonary embolism.
Read the detailed description
Total hip arthroplasty (THA) is frequently associated with substantial perioperative blood loss, which may increase the need for blood transfusions and prolong hospitalization. Tranexamic acid (TXA), an antifibrinolytic agent, is widely used in orthopedic surgery to reduce bleeding; however, the optimal route of administration and its effects on coagulation remain subjects of ongoing investigation.
This prospective comparative study evaluates the efficacy and safety of combined intravenous and topical TXA administration compared with intravenous TXA alone in patients undergoing elective primary cementless THA for primary osteoarthritis. Patients are randomized into two treatment groups. The intravenous group receives 1 g TXA before surgical incision, while the combined group receives 1 g intravenous TXA preoperatively together with an additional 2 g topical TXA applied locally around the prosthesis during wound closure.
The primary objective is to determine whether combined administration reduces postoperative blood loss and transfusion requirements. Secondary objectives include assessment of perioperative hemoglobin changes, wound complications, length of hospital stay, and the incidence of thromboembolic complications.
To further evaluate coagulation safety, serial rotational thromboelastometry (ROTEM) measurements are performed before surgery, during surgery, and after surgery. ROTEM analysis is used to assess clot formation, clot strength, fibrinolysis, and potential hypercoagulability associated with TXA administration. The study aims to determine whether dual-route TXA administration improves perioperative blood management without increasing thromboembolic risk in patients undergoing primary THA.
- Conditions
- Total Hip Arthroplasty, Tranexamic Acid Administration, Perioperative Blood Loss, Coagulation Monitoring Using ROTEM
- Being tested
- Intravenous Tranexamic Acid, Combined Intravenous and Intraarticular Tranexamic Acid
- Keywords
- hip arthroplasty, rotational thromboelastometry, tranexamic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Tranexamic AcidDrug
Participants receive a single 1 g intravenous dose of tranexamic acid administered before surgical incision during primary total hip arthroplasty without additional topical application.
Combined Intravenous and Intraarticular Tranexamic AcidDrug
Participants receive tranexamic acid administered through two routes during primary total hip arthroplasty. A 1 g intravenous dose is administered before surgical incision, followed by an additional 2 g topical dose applied locally around the hip prosthesis during wound closure after implantation of the components and achievement of hemostasis.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants receive 1 g intravenous tranexamic acid before surgical incision and an additional 2 g topical tranexamic acid applied locally around the prosthesis during wound closure in primary total hip arthroplasty. Receives: Drug: Combined Intravenous and Intraarticular Tranexamic Acid |
| Intravenous TXA Only | Active comparator | Participants receive 1 g intravenous tranexamic acid before surgical incision during primary total hip arthroplasty without additional topical tranexamic acid administration. Receives: Drug: Intravenous Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Postoperative Blood Loss Measured by Surgical Drain Output and Hemoglobin Change
Total postoperative blood loss measured in milliliters during the first 48 hours after primary total hip arthroplasty, calculated using surgical drain output and perioperative hemoglobin level changes.
Measured: Up to 48 hours after surgery
Secondary outcomes (3)
Clotting Time (CT) Measured by ROTEM EXTEM Assay
Clotting time measured in seconds using rotational thromboelastometry (ROTEM EXTEM assay) to evaluate initiation of coagulation after tranexamic acid administration.
Measured: Baseline (15-20 minutes before intravenous TXA administration), 30 minutes after intravenous TXA administration, and 1 hour after surgery
Maximum Clot Firmness (MCF) Measured by ROTEM EXTEM Assay
Maximum clot firmness measured in millimeters using rotational thromboelastometry (ROTEM EXTEM assay) to evaluate clot strength and potential hypercoagulability.
Measured: Baseline (15-20 minutes before intravenous TXA administration), 30 minutes after intravenous TXA administration, and 1 hour after surgery
Maximum Lysis (ML) Measured by ROTEM EXTEM Assay
Maximum lysis percentage measured using rotational thromboelastometry (ROTEM EXTEM assay) to assess fibrinolytic activity following tranexamic acid administration.
Measured: Baseline (15-20 minutes before intravenous TXA administration), 30 minutes after intravenous TXA administration, and 1 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start1 Jun 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Anne's University Hospital Brno, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pavel Brančík, Principal investigator, First Department of Orthopedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610863
- Sponsor's protocol ID
- IIT/2022/BR
- Other IDs
- Identification Number: 2212020
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Intravenous and Topical Tranexamic Acid in Total Hip Arthroplasty: A Prospective Comparative Study With Rotational Thromboelastometry Monitoring
- ClinicalTrials.gov ID
- NCT07610863
- Acronym / sponsor ID
- IIT/2022/BR
- Conditions
- Total Hip Arthroplasty, Tranexamic Acid Administration, Perioperative Blood Loss, Coagulation Monitoring Using ROTEM
- Keywords
- hip arthroplasty, rotational thromboelastometry, tranexamic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- St. Anne's University Hospital Brno, Czech RepublicUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 28 May 2026 (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.
This prospective study evaluates whether combined intravenous and topical administration of tranexamic acid (TXA) can safely reduce blood loss in patients undergoing primary total hip replacement surgery. Tranexamic acid is commonly used during orthopedic surgery to decrease bleeding and reduce the need for blood transfusions.
Participants undergoing elective primary total hip arthroplasty are assigned to receive either intravenous TXA alone or a combination of intravenous and topical TXA applied directly around the hip joint during surgery. The study compares postoperative blood loss, changes in hemoglobin levels, transfusion requirements, length of hospital stay, and postoperative complications between the treatment groups.
The study also uses rotational thromboelastometry (ROTEM), a specialized blood coagulation monitoring method, to evaluate whether combined TXA administration affects blood clotting or increases the risk of thromboembolic complications such as deep vein thrombosis or pulmonary embolism.
Detailed description
Total hip arthroplasty (THA) is frequently associated with substantial perioperative blood loss, which may increase the need for blood transfusions and prolong hospitalization. Tranexamic acid (TXA), an antifibrinolytic agent, is widely used in orthopedic surgery to reduce bleeding; however, the optimal route of administration and its effects on coagulation remain subjects of ongoing investigation.
This prospective comparative study evaluates the efficacy and safety of combined intravenous and topical TXA administration compared with intravenous TXA alone in patients undergoing elective primary cementless THA for primary osteoarthritis. Patients are randomized into two treatment groups. The intravenous group receives 1 g TXA before surgical incision, while the combined group receives 1 g intravenous TXA preoperatively together with an additional 2 g topical TXA applied locally around the prosthesis during wound closure.
The primary objective is to determine whether combined administration reduces postoperative blood loss and transfusion requirements. Secondary objectives include assessment of perioperative hemoglobin changes, wound complications, length of hospital stay, and the incidence of thromboembolic complications.
To further evaluate coagulation safety, serial rotational thromboelastometry (ROTEM) measurements are performed before surgery, during surgery, and after surgery. ROTEM analysis is used to assess clot formation, clot strength, fibrinolysis, and potential hypercoagulability associated with TXA administration. The study aims to determine whether dual-route TXA administration improves perioperative blood management without increasing thromboembolic risk in patients undergoing primary THA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Combined Intravenous and Intraarticular Tranexamic AcidParticipants receive 1 g intravenous tranexamic acid before surgical incision and an additional 2 g topical tranexamic acid applied locally around the prosthesis during wound closure in primary total hip arthroplasty. |
| Intravenous TXA Only | Active comparator | Drug: Intravenous Tranexamic AcidParticipants receive 1 g intravenous tranexamic acid before surgical incision during primary total hip arthroplasty without additional topical tranexamic acid administration. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adults undergoing elective primary cementless total hip arthroplasty for primary hip osteoarthritis
- Preoperative hemoglobin level ≥130 g/L
- Ability to provide written informed consent
Key exclusion criteria (10 listed)
- Post-traumatic or secondary hip arthritis
- Known allergy or hypersensitivity to tranexamic acid
- History of deep vein thrombosis or pulmonary embolism
- Current anticoagulant therapy
- Known coagulation disorder
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 Tranexamic AcidParticipants receive a single 1 g intravenous dose of tranexamic acid administered before surgical incision during primary total hip arthroplasty without additional topical application. | Drug | Intravenous TXA Only |
| Combined Intravenous and Intraarticular Tranexamic AcidParticipants receive tranexamic acid administered through two routes during primary total hip arthroplasty. A 1 g intravenous dose is administered before surgical incision, followed by an additional 2 g topical dose applied locally around the hip prosthesis during wound closure after implantation of the components and achievement of hemostasis. | Drug | Intervention Group |
Primary outcome
Total Postoperative Blood Loss Measured by Surgical Drain Output and Hemoglobin Change
Time frame: Up to 48 hours after surgery
Total postoperative blood loss measured in milliliters during the first 48 hours after primary total hip arthroplasty, calculated using surgical drain output and perioperative hemoglobin level changes.
3 secondary outcomes
Clotting Time (CT) Measured by ROTEM EXTEM Assay
Time frame: Baseline (15-20 minutes before intravenous TXA administration), 30 minutes after intravenous TXA administration, and 1 hour after surgery
Maximum Clot Firmness (MCF) Measured by ROTEM EXTEM Assay
Time frame: Baseline (15-20 minutes before intravenous TXA administration), 30 minutes after intravenous TXA administration, and 1 hour after surgery
Maximum Lysis (ML) Measured by ROTEM EXTEM Assay
Time frame: Baseline (15-20 minutes before intravenous TXA administration), 30 minutes after intravenous TXA administration, and 1 hour 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 28 May 2026.
- Individual participant dataSharing planned: Undecided
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
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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.
Pavel Brančík principal investigator
First Department of Orthopedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous Tranexamic Acid and Combined Intravenous and Intraarticular Tranexamic Acid in people with Total Hip Arthroplasty and Tranexamic Acid Administration, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
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 28 May 2026. 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 Czechia. 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. 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?
Total Postoperative Blood Loss Measured by Surgical Drain Output and Hemoglobin Change (time frame: Up to 48 hours after surgery). 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 28 May 2026.