Total Hip Arthroplasty Clinical Trial
Official title:
The Effect of Tranexamic Acid on Blood Coagulation in Total Hip Arthroplasty Surgery Based on Rotational Thromboelastometry (ROTEM®).
NCT number | NCT03897621 |
Other study ID # | 18D.581 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 20, 2019 |
Est. completion date | December 20, 2022 |
Verified date | April 2023 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 20, 2022 |
Est. primary completion date | December 20, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - The study population will include total of 200 adults (age range of 18 - 85 years) who are in the American Society of Anesthesiologists (ASA) Physical Status (PS) 1-3. Inclusion criteria are patients undergoing unilateral, primary, total hip arthroplasty. Exclusion Criteria: - Exclusion criteria include patient's refusal, patients with history of significant coagulopathy or on anticoagulation therapy. Female patients who are pregnant or nursing will be excluded. In addition, patients with anemia (Hb < 8 g/dL) or who received blood transfusion within one week before surgery will be excluded. Patient receiving subcutaneous heparin on the same day prior to surgery will be also excluded. |
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Thomas Jefferson University |
United States,
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. — View Citation
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. — View Citation
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 — View Citation
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 201 — View Citation
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. — View Citation
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. 201 — View Citation
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. — View Citation
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.00000 — View Citation
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 — View Citation
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 E — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fibrinolysis | Fibrinolysis based on ROTEM parameter, defined as ML (maxium lysis) >15% | after induction of anesthesia (baseline), | |
Primary | Fibrinolysis | Fibrinolysis based on ROTEM parameter, defined as ML (maxium lysis) >15% | 45 min after drug administration, | |
Primary | Fibrinolysis | Fibrinolysis based on ROTEM parameter, defined as ML (maxium lysis) >15% | one hour after the end of surgery | |
Secondary | Blood loss | amount of blood loss in milliliter during surgery | during surgery (intraoperative) | |
Secondary | blood transfusion | Amount of Packed Red Blood Cells (PRBC) transfused | Intraoperative and up to 72-hour after surgery | |
Secondary | pre- and postoperative hemoglobin level | Pre and postoperative hemoglobin level in grams per deciliter | up to 72-hour after surgery | |
Secondary | Wound infection | Incidence of wound infection | up to 72-hour after surgery | |
Secondary | Hematoma | Incidence of hematoma | up to72-hour after surgery | |
Secondary | Thrombotic events (PE, DVT). | Incidence of thrombotic events (pulmonary embolism, deep vein thrombosis) | up to 72-hour after surgery |
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