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| ID | Type | Description | Link |
|---|---|---|---|
| Identification Number: 2212020 | Other Identifier | State Institute for Drug Control - Czechia |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Tranexamic Acid | Drug | Participants receive a single 1 g intravenous dose of tranexamic acid administered before surgical incision during primary total hip arthroplasty without additional topical application. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (15-20 minutes before intravenous TXA administration), 30 minutes after intravenous TXA administration, and 1 hour after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pavel Brančík | First Department of Orthopedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Department of Orthopaedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia | Brno | Czechia | 60200 | Czechia |
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| Combined Intravenous and Intraarticular Tranexamic Acid | Drug | 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. |
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| 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. | 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. | Baseline (15-20 minutes before intravenous TXA administration), 30 minutes after intravenous TXA administration, and 1 hour after surgery |