Blood LossNCT06903299
Prospective Investigation of Intra-Articular Tranexamic Acid Use in Elective Hip Arthroplasty
An observational study of Blood Loss and Hemoglobin Change, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
Trial summary
Tranexamic acid (trans-4-aminomethyl cyclohexane carboxylic acid) is an antifibrinolytic substance that chemically belongs to the group of e-carboxylic acids. TXA is a synthetic amino acid derivative of lysine that competitively inhibits the activation of plasminogen to the serine protease, plasmin. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blood Loss, Hemoglobin Change, Blood Transfusion
- What is being tested?
- Intra-articular Tranexamic acid application
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Child, Adult, Older adult
Study population: Patients undergoing elective hip replacement in the First Department of Orthopaedic Surgery, St. Anne's University Hospital, Brno, Czechia from 2023 to 2026.
Who may be able to join
- Elective hip replacement
Who cannot join
- Traumatic hip replacement indication
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, 62700
About this study
Official title: Utilisation of Tranexamic Acid in Elective Hip Arthroplasty
Tranexamic acid (trans-4-aminomethyl cyclohexane carboxylic acid) is an antifibrinolytic substance that chemically belongs to the group of e-carboxylic acids. TXA is a synthetic amino acid derivative of lysine that competitively inhibits the activation of plasminogen to the serine protease, plasmin. TXA is a competitive inhibitor of tissue plasminogen activator, blocking the lysine-binding sites of plasminogen, resulting in inhibition of plasminogen activation and fibrin binding to plasminogen and therefore impairment of fibrinolysis.
Due to its antifibrinolytic effect (reduction of bleeding), TXA has been recently an increasing interest in orthopaedics, especially in elective major joint replacements.
Read more
The total hip arthroplasties (ΤΗΑ) are associated with perioperative blood losses exceeding 500 mL. Blood loss volumes are dependent on the chosen surgical approach and technique. Some patients that undergo elective hip replacement receive at least one blood unit in postoperative care. Heterotopic ossification is also a common complication after THA, presented as bone in soft tissue where bone normally does not appear. TXA reduces postoperative blood losses and consequently leads to less frequent blood transfusions. This has an impact on the economic burden for the health care system. Increased blood loss could lead to longer length of stay at the hospital and the connected economic consequences. TXA further reduces the incidence of heterotopic ossification after elective THA.
Objectives:
The aim of this study is to prospectively evaluate postoperative blood losses, hemoglobin decline and associated blood transfusion, heterotopic ossification and other parameters in patients with intraarticular application of Tranexamic acid during THA.
Read the detailed description
This prospective, parallel-group clinical study was conducted at the First Department of Orthopaedic Surgery, St. Anne's University Hospital and the Faculty of Medicine, Masaryk University, Brno, Czech Republic. Patient recruitment and prospective data collection were performed from January 1, 2023, to December 31, 2025.
The study was designed to evaluate whether the addition of intra-articular tranexamic acid (TXA) to standard intravenous TXA administration improves perioperative blood-management outcomes in patients undergoing elective primary total hip arthroplasty (THA). Eligible patients undergoing elective THA were allocated before surgery to one of two parallel treatment groups. Patients undergoing arthroplasty for traumatic indications were excluded.
All procedures were performed under spinal anesthesia using an anterolateral Watson-Jones approach. All patients received 1 g of intravenous TXA before skin incision. In the intravenous-only group, no additional local TXA was administered. In the combined-treatment group, patients received an additional 2 g of TXA diluted in 10 mL of saline, applied intra-articularly around the implanted prosthesis after definitive component implantation, completion of surgical haemostasis, and drying of the operative field, immediately before closure of the fascia lata.
Standardized perioperative management was used in both groups. Meticulous electrocautery haemostasis was performed, and a single Redon suction drain was placed in the operated hip and removed 24 hours after surgery. Patients received perioperative thromboprophylaxis with low-molecular-weight heparin according to the institutional protocol.
The principal objective of the study was to assess the effect of additional intra-articular TXA on perioperative blood loss and transfusion requirements. Perioperative outcomes included postoperative drainage volume, changes in haemoglobin concentration, red blood cell transfusion requirements, and length of hospital stay. Haemoglobin concentration was recorded preoperatively, on the day of surgery, and on postoperative day 1. Changes in haemoglobin concentration were evaluated from the preoperative value to the day of surgery and from the preoperative value to postoperative day 1. Red blood cell transfusion requirements were assessed both as the proportion of patients requiring transfusion and according to the number of transfused units.
Postoperative wound-related and medical complications were also prospectively evaluated. These included persistent wound leakage, requirement for single-use negative-pressure wound therapy, debridement with antibiotics and implant retention (DAIR), implant explantation, and clinically diagnosed thromboembolic complications. Surgical wounds were routinely assessed during the postoperative period, and persistent or progressive wound complications were treated according to the institutional protocol.
The study was intended to determine whether combined intravenous and intra-articular administration of TXA provides additional haemostatic benefit compared with intravenous TXA alone while maintaining an acceptable postoperative safety profile in patients undergoing elective primary THA.
- Being tested
- Intra-articular Tranexamic acid application
- Medical subject headings
- Hemorrhage, Ossification, Heterotopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular Tranexamic acid applicationDrug
Intra-articular Tranexamic acid application during THA and evaluation of postoperative blood losses, hemoglobin decline and associated blood transfusion, heterotopic ossification and other parameters.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group - COMB | Combined intravenous and intra-articular TXA Receives: Drug: Intra-articular Tranexamic acid application | |
| Control Group - IV group | Treatment allocation to intravenous TXA alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Blood Loss
Total measured blood loss (in mL) within the first 24 to 48 hours after total hip arthroplasty (THA), calculated from surgical drains and hemoglobin change.
Measured: 48 hours postoperatively
Secondary outcomes (3)
Hemoglobin Change
Change in hemoglobin levels (g/dL) from preoperative baseline to 24 and 48 hours postoperatively. Change from baseline.
Measured: Baseline, 24 hours, and 48 hours postoperatively
Incidence of Heterotopic Ossification
Number of patients developing heterotopic ossification, assessed using radiographs at 6 weeks and 3 months postoperatively.
Measured: 1 year postoperatively
Incidence of Postoperative Complications
Number of patients experiencing complications such as deep vein thrombosis (DVT), pulmonary embolism (PE), wound infections, and other adverse events.
Measured: Up to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Anne's University Hospital Brno, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903299
- Sponsor's protocol ID
- 83V/2022 - AM
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilisation of Tranexamic Acid in Elective Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06903299
- Acronym / sponsor ID
- 83V/2022 - AM
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- St. Anne's University Hospital Brno, Czech RepublicUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Mar 2025 (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.
Tranexamic acid (trans-4-aminomethyl cyclohexane carboxylic acid) is an antifibrinolytic substance that chemically belongs to the group of e-carboxylic acids. TXA is a synthetic amino acid derivative of lysine that competitively inhibits the activation of plasminogen to the serine protease, plasmin. TXA is a competitive inhibitor of tissue plasminogen activator, blocking the lysine-binding sites of plasminogen, resulting in inhibition of plasminogen activation and fibrin binding to plasminogen and therefore impairment of fibrinolysis.
Due to its antifibrinolytic effect (reduction of bleeding), TXA has been recently an increasing interest in orthopaedics, especially in elective major joint replacements.
The total hip arthroplasties (ΤΗΑ) are associated with perioperative blood losses exceeding 500 mL. Blood loss volumes are dependent on the chosen surgical approach and technique. Some patients that undergo elective hip replacement receive at least one blood unit in postoperative care. Heterotopic ossification is also a common complication after THA, presented as bone in soft tissue where bone normally does not appear. TXA reduces postoperative blood losses and consequently leads to less frequent blood transfusions. This has an impact on the economic burden for the health care system. Increased blood loss could lead to longer length of stay at the hospital and the connected economic consequences. TXA further reduces the incidence of heterotopic ossification after elective THA.
Objectives:
The aim of this study is to prospectively evaluate postoperative blood losses, hemoglobin decline and associated blood transfusion, heterotopic ossification and other parameters in patients with intraarticular application of Tranexamic acid during THA.
Detailed description
This prospective, parallel-group clinical study was conducted at the First Department of Orthopaedic Surgery, St. Anne's University Hospital and the Faculty of Medicine, Masaryk University, Brno, Czech Republic. Patient recruitment and prospective data collection were performed from January 1, 2023, to December 31, 2025.
The study was designed to evaluate whether the addition of intra-articular tranexamic acid (TXA) to standard intravenous TXA administration improves perioperative blood-management outcomes in patients undergoing elective primary total hip arthroplasty (THA). Eligible patients undergoing elective THA were allocated before surgery to one of two parallel treatment groups. Patients undergoing arthroplasty for traumatic indications were excluded.
All procedures were performed under spinal anesthesia using an anterolateral Watson-Jones approach. All patients received 1 g of intravenous TXA before skin incision. In the intravenous-only group, no additional local TXA was administered. In the combined-treatment group, patients received an additional 2 g of TXA diluted in 10 mL of saline, applied intra-articularly around the implanted prosthesis after definitive component implantation, completion of surgical haemostasis, and drying of the operative field, immediately before closure of the fascia lata.
Standardized perioperative management was used in both groups. Meticulous electrocautery haemostasis was performed, and a single Redon suction drain was placed in the operated hip and removed 24 hours after surgery. Patients received perioperative thromboprophylaxis with low-molecular-weight heparin according to the institutional protocol.
The principal objective of the study was to assess the effect of additional intra-articular TXA on perioperative blood loss and transfusion requirements. Perioperative outcomes included postoperative drainage volume, changes in haemoglobin concentration, red blood cell transfusion requirements, and length of hospital stay. Haemoglobin concentration was recorded preoperatively, on the day of surgery, and on postoperative day 1. Changes in haemoglobin concentration were evaluated from the preoperative value to the day of surgery and from the preoperative value to postoperative day 1. Red blood cell transfusion requirements were assessed both as the proportion of patients requiring transfusion and according to the number of transfused units.
Postoperative wound-related and medical complications were also prospectively evaluated. These included persistent wound leakage, requirement for single-use negative-pressure wound therapy, debridement with antibiotics and implant retention (DAIR), implant explantation, and clinically diagnosed thromboembolic complications. Surgical wounds were routinely assessed during the postoperative period, and persistent or progressive wound complications were treated according to the institutional protocol.
The study was intended to determine whether combined intravenous and intra-articular administration of TXA provides additional haemostatic benefit compared with intravenous TXA alone while maintaining an acceptable postoperative safety profile in patients undergoing elective primary THA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - COMB | – | Drug: Intra-articular Tranexamic acid applicationCombined intravenous and intra-articular TXA |
| Control Group - IV group | – | –Treatment allocation to intravenous TXA alone |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing elective hip replacement in the First Department of Orthopaedic Surgery, St. Anne's University Hospital, Brno, Czechia from 2023 to 2026.
Key inclusion criteria (1 listed)
- Elective hip replacement
Key exclusion criteria (1 listed)
- Traumatic hip replacement indication
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 |
|---|---|---|
| Intra-articular Tranexamic acid applicationIntra-articular Tranexamic acid application during THA and evaluation of postoperative blood losses, hemoglobin decline and associated blood transfusion, heterotopic ossification and other parameters. | Drug | Intervention Group - COMB |
Primary outcome
Postoperative Blood Loss
Time frame: 48 hours postoperatively
Total measured blood loss (in mL) within the first 24 to 48 hours after total hip arthroplasty (THA), calculated from surgical drains and hemoglobin change.
3 secondary outcomes
Hemoglobin Change
Time frame: Baseline, 24 hours, and 48 hours postoperatively
Incidence of Heterotopic Ossification
Time frame: 1 year postoperatively
Incidence of Postoperative Complications
Time frame: Up to 30 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Loss and Hemoglobin Change, 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 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?
This study is still under way. Results are not available in the source record yet.
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?
Postoperative Blood Loss (time frame: 48 hours postoperatively). 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 17 Sep 2026.