Coagulation Monitoring Using ROTEM, Perioperative Blood Loss, Total Hip Arthroplasty, Tranexamic Acid Administration
Conditions
Keywords
hip arthroplasty, rotational thromboelastometry, tranexamic acid
Brief 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. 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.
Interventions
DRUGIntravenous Tranexamic Acid
Participants receive a single 1 g intravenous dose of tranexamic acid administered before surgical incision during primary total hip arthroplasty without additional topical application.
DRUGCombined Intravenous and Intraarticular Tranexamic Acid
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.
Sponsors
St. Anne's University Hospital Brno, Czech Republic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Adults undergoing elective primary cementless total hip arthroplasty for primary hip osteoarthritis * Preoperative hemoglobin level ≥130 g/L * Ability to provide written informed consent
Exclusion criteria
* 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 * Significant hepatic or renal dysfunction * Type 1 diabetes mellitus * Significant cardiovascular disease * Traumatic indication for total hip arthroplasty
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Postoperative Blood Loss Measured by Surgical Drain Output and Hemoglobin Change | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clotting Time (CT) Measured by ROTEM EXTEM Assay | Baseline (15-20 minutes before intravenous TXA administration), 30 minutes after intravenous TXA administration, and 1 hour after surgery | Clotting time measured in seconds using rotational thromboelastometry (ROTEM EXTEM assay) to evaluate initiation of coagulation after tranexamic acid administration. |
| Maximum Clot Firmness (MCF) Measured by ROTEM EXTEM Assay | Baseline (15-20 minutes before intravenous TXA administration), 30 minutes after intravenous TXA administration, and 1 hour after surgery | Maximum clot firmness measured in millimeters using rotational thromboelastometry (ROTEM EXTEM assay) to evaluate clot strength and potential hypercoagulability. |
| Maximum Lysis (ML) Measured by ROTEM EXTEM Assay | Baseline (15-20 minutes before intravenous TXA administration), 30 minutes after intravenous TXA administration, and 1 hour after surgery | Maximum lysis percentage measured using rotational thromboelastometry (ROTEM EXTEM assay) to assess fibrinolytic activity following tranexamic acid administration. |
Countries
Czechia
Contacts
PRINCIPAL_INVESTIGATORPavel Brančík
First Department of Orthopedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia
Outcome results
None listed