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Total hip arthroplasty (THA) is associated with blood loss ranging from 300 to 2000 mL. Tranexamic acid (TXA) is frequently administered prophylactically during this procedure to reduce blood loss by inhibiting fibrinolysis or by stopping naturally occurring clot resolution. TXA is employed currently based on a surgeon's preference. The objective of this study is to quantitate the degree of fibrinolysis using rotational thromboelastometry (ROTEM) and investigate the role of TXA prophylaxis on blood loss in patients undergoing THA in a double-blind fashion. Our hypothesis is that fibrinolysis is minimal at most and TXA prophylaxis is not necessary during THA. All patients, whether they receive TXA or normal saline, will not be at risk, as at this time no data exists to determine which approach is safer or more effective. This is the first study to compare TXA vs. placebo in a double-blinded, randomized controlled trial.
Total hip arthroplasty (THA) is associated with moderate blood loss ranging from 300 to 2000 mL. Tranexamic acid (TXA) is frequently administered prophylactically during this procedure to reduce blood loss by inhibiting fibrinolysis. Most clinical studies reported potential benefit of the treatment demonstrated by less estimated blood loss (EBL), reduced hemoglobin/hematocrit (HH) change, and reduced transfused packed red blood cells (PRBC). However, bleeding complication may be affected more significantly by the degree of surgical trauma and comorbidity of patients than coagulation abnormality. Further, the frequency and severity of fibrinolysis during these procedures have not been well studied. Additionally, TXA administration may increase the tendency of postoperative venous thrombosis by inhibiting fibrinolysis in already prothrombotic patients. The objective of this study is to quantitate the degree of fibrinolysis using rotational thromboelastometry (ROTEM) and investigate the role of TXA prophylaxis on clinical outcome in patients undergoing THA in a double-blind fashion. Our hypothesis is that fibrinolysis is minimal at most and TXA prophylaxis is not necessary during primary THA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tranexamic acid | Experimental | Patients undergoing unilateral, primary, total hip arthroplasty with English as their native language |
|
| Normal saline | Placebo Comparator | Patients undergoing unilateral, primary, total hip arthroplasty with English as their native language |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | tranexamic acid will be administered intravenously after induction of anesthesia (a bolus of 10 mg/kg or maximal dose of 1g). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fibrinolysis | Fibrinolysis based on ROTEM parameter, defined as ML (maxium lysis) >15% | after induction of anesthesia (baseline), |
| Fibrinolysis | Fibrinolysis based on ROTEM parameter, defined as ML (maxium lysis) >15% | 45 min after drug administration, |
| Fibrinolysis | Fibrinolysis based on ROTEM parameter, defined as ML (maxium lysis) >15% | one hour after the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss | amount of blood loss in milliliter during surgery | during surgery (intraoperative) |
| blood transfusion | Amount of Packed Red Blood Cells (PRBC) transfused |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uzung Yoon | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28448319 | Result | Wu Y, Yang T, Zeng Y, Si H, Cao F, Shen B. Tranexamic acid reduces blood loss and transfusion requirements in primary simultaneous bilateral total knee arthroplasty: a meta-analysis of randomized controlled trials. Blood Coagul Fibrinolysis. 2017 Oct;28(7):501-508. doi: 10.1097/MBC.0000000000000637. | |
| 28505683 | Result |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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double-blinded randomized controlled trial
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| Placebo | Drug | Patients in the placebo group will receive normal saline (a bolus of sodium chloride 0.9%, 0.1 mL/kg or maximal dose of 10 mL). |
|
| Intraoperative and up to 72-hour after surgery |
| pre- and postoperative hemoglobin level | Pre and postoperative hemoglobin level in grams per deciliter | up to 72-hour after surgery |
| Wound infection | Incidence of wound infection | up to 72-hour after surgery |
| Hematoma | Incidence of hematoma | up to72-hour after surgery |
| Thrombotic events (PE, DVT). | Incidence of thrombotic events (pulmonary embolism, deep vein thrombosis) | up to 72-hour after surgery |
| Prieto HA, Vincent HK, Deen JT, Iams DA, Parvataneni HK. Tranexamic Acid Effectively Reduces Blood Loss and Transfusion Rates during Simultaneous Bilateral Total Knee Arthroplasty. J Knee Surg. 2018 Mar;31(3):270-276. doi: 10.1055/s-0037-1603333. Epub 2017 May 15. |
| 26559015 | Result | Na HS, Shin HJ, Lee YJ, Kim JH, Koo KH, Do SH. The effect of tranexamic acid on blood coagulation in total hip replacement arthroplasty: rotational thromboelastographic (ROTEM(R)) analysis. Anaesthesia. 2016 Jan;71(1):67-75. doi: 10.1111/anae.13270. Epub 2015 Nov 12. |
| 28633147 | Result | Watts CD, Houdek MT, Sems SA, Cross WW, Pagnano MW. Tranexamic Acid Safely Reduced Blood Loss in Hemi- and Total Hip Arthroplasty for Acute Femoral Neck Fracture: A Randomized Clinical Trial. J Orthop Trauma. 2017 Jul;31(7):345-351. doi: 10.1097/BOT.0000000000000837. |
| 28692467 | Result | Zufferey PJ, Lanoiselee J, Chapelle C, Borisov DB, Bien JY, Lambert P, Philippot R, Molliex S, Delavenne X; investigators of the PeriOpeRative Tranexamic acid in hip arthrOplasty (PORTO) Study. Intravenous Tranexamic Acid Bolus plus Infusion Is Not More Effective than a Single Bolus in Primary Hip Arthroplasty: A Randomized Controlled Trial. Anesthesiology. 2017 Sep;127(3):413-422. doi: 10.1097/ALN.0000000000001787. |
| 18042876 | Result | Toledo P, McCarthy RJ, Hewlett BJ, Fitzgerald PC, Wong CA. The accuracy of blood loss estimation after simulated vaginal delivery. Anesth Analg. 2007 Dec;105(6):1736-40, table of contents. doi: 10.1213/01.ane.0000286233.48111.d8. |
| 9354828 | Result | Brecher ME, Monk T, Goodnough LT. A standardized method for calculating blood loss. Transfusion. 1997 Oct;37(10):1070-4. doi: 10.1046/j.1537-2995.1997.371098016448.x. |
| 21918164 | Result | Theusinger OM, Wanner GA, Emmert MY, Billeter A, Eismon J, Seifert B, Simmen HP, Spahn DR, Baulig W. Hyperfibrinolysis diagnosed by rotational thromboelastometry (ROTEM) is associated with higher mortality in patients with severe trauma. Anesth Analg. 2011 Nov;113(5):1003-12. doi: 10.1213/ANE.0b013e31822e183f. Epub 2011 Sep 14. |
| 25098850 | Result | Ram GG, Suresh P, Vijayaraghavan PV. Surgeons often underestimate the amount of blood loss in replacement surgeries. Chin J Traumatol. 2014;17(4):225-8. |
| 18440953 | Result | Levrat A, Gros A, Rugeri L, Inaba K, Floccard B, Negrier C, David JS. Evaluation of rotation thrombelastography for the diagnosis of hyperfibrinolysis in trauma patients. Br J Anaesth. 2008 Jun;100(6):792-7. doi: 10.1093/bja/aen083. Epub 2008 Apr 24. |
| 40735345 | Derived | Yoon U, Beausang D, Elia E, Torjman M, Mojica J, Purtill J, Nazarian D, Courtney PM, Kang Y. The effect of tranexamic acid on blood coagulation in primary total hip arthroplasty using rotational thromboelastometry: a randomized controlled trial. EClinicalMedicine. 2025 Jul 21;86:103374. doi: 10.1016/j.eclinm.2025.103374. eCollection 2025 Aug. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |