Tranexamic acid in total hip arthoplasty: management of complications and use.
Pharmacologic Features of TA
TA is a synthetic lysine analog that is a competitive inhibitor of plasminogen and plasmin, inhibiting fibrinolysis by preventing conversion to plasmin (Haspl, Oremus, Sostaric, & Trkulja, 2014; Wei & Liu, 2015). In a patient with normal renal function, TA has a half-life of 2-11 hours. Commonly reported side effects include headache, numbness or weakness, confusion, dizziness, fatigue, and color vision disturbances (Epocrates, 2016). Hypotension can occur if TA is infused too rapidly. Thrombosis development also is possible as the drug promotes thickening and clotting to prevent bleeding. A provider must weigh risks and benefits before ordering TA, which thus may not be appropriate for a patient at risk for clotting/ thrombosis. Contraindications include renal impairment (TA excreted primarily through the urine), history of subarachnoid hemorrhage, history or current thrombosis or clotting issues, known allergy to TA, and color vision disturbances (Haspl et al., 2014).
Appropriate Dose and Routes for TA
Route of administration and dosing of TA depend on provider preference, although multiple studies have focused on different doses and routes with associated outcomes. For example, Clave, Dumser, Fazilleau, and Lacroix (2011) found a reduction in blood loss when TA was given lg intravenously (IV) at time of incision followed by 1g IV at 3, 7, and 12 hours postoperatively. A study by Copeland and colleagues (2013) retrospectively analyzed data comparing IV versus oral TA for THA, with IV dose of 15 mg/kg with a maximum of 1.2 g given at the time of anesthesia induction compared to oral dose 25 mg/kg with a maximum of 2 g 2 hours before surgery. Results indicated the odds of receiving a transfusion postoperatively were significantly higher in the IV group (7.9% in IV vs. 4.6% in oral, p=0.019), suggesting the need for a randomized controlled trial to validate these results.
Of note, Copeland and coauthors (2013) found decreased need for transfusions with oral TA while maintaining less postoperative blood drainage and equivalence in safety. Authors determined the level of plasma TA following IV administration decreased after 6 hours from about 45 mg/L to under 10 mg/L; in contrast, oral TA administration remained consistently above the hemostatic threshold over 6 hours. This could be beneficial, as oral TA will have a longer effect. If the patient's surgery were to last longer than expected, or if a postoperative complication (e.g., bleeding) occurred within the 6hour period, the oral dose of TA would have continued effect and could help reduce the amount of bleeding compared to IV dosing. While the route and dose for TA administration will be determined by the surgeon, nurses must be educated on available options.
Side Effects and Complications of TA
TA has been reported to cause serious complications, including increased risk of venous thromboembolism (VTE). Duncan and colleagues (2014) conducted a large, single-center, retrospective cohort study to examine the frequency of VTE and its relation to mortality up to 30 days after surgery in patients who received TA in THA or total knee arthroplasty (TKA). Authors reviewed the records of patients who underwent THA and TKA patients over a 5-year period to determine the incidence of VTE within 30 days after surgery. TA use in THA and TKA did not affect the frequency of VTE; however, researchers noted a major factor affecting results was candidate selection for TA administration. They expressed concern for patients who presented with significant vascular occlusion comorbidity. Of importance, although this study included patients with significant comorbidities, findings indicated overall frequency of clinically significant VTE was lower when TA was used.
A meta-analysis by Li and colleagues (2013) compared 19 trials. Of 539 patients who received TA, only 15 reported deep vein thrombosis (DVT); 19 of 535 patients who did not receive TA reported DVT, showing no statistical significance between the groups (p=0.39). Incidence of pulmonary embolus was less, with only three from the TA group and one from the non-TA group affected (p=0.45).
Healthcare providers must be aware of the potential for thromboembolic events (Wei & Liu, 2015). Patients undergoing THA are at a higher risk for VTE; if TA is given to persons already at high risk, increased monitoring is warranted. Patients with vascular occlusive disease, cardiovascular disease, prior immobilization, inflammatory bowel disease, and many forms of cancer experience increased risk for thromboembolic events but also may be among patients requiring THA. As a major surgery followed by decreased postoperative mobility, THA carries increased risk for VTE. Authors concluded monitoring for a thromboembolic event is imperative.
FIGURE 1. Overview: Patient Management for TA Use Preoperative * Is patient an appropriate candidate? * Baseline renal function * Baseline coagulation studies * Route/dose * Appropriate for the specific patient * Oral if history of SAH Intraoperative * No PCN with TA infusion * Monitor for hypotension * Monitor EBL--should be significantly less with TA * Monitor urinary output if renal disease--TA excreted through urine Post-operative * Proper chemical DVT/PE prophylaxis * ASA is preferred through research * Early mobilization * Hip precautions * Monitor CBC--look for steady hemoglobin * If a significant drop is noted, there is an increased risk of post-operative bleeding ASA = aspirin, CBC = completed blood count, DVT/PE = deep venous thrombosis/pulmonary embolus, EBL = estimated blood loss, PCN = penicillin, SAH = subarachnoid hemorrhage, TA = tranexamic acid
Management of the Preoperative Candidate
Understanding the safety profile and contraindications for TA is essential. TA should be given IV to patients with a history of subarachnoid hemorrhage because of increased chance of infarct and cerebral edema. Providers should remember TA is excreted through the urine; thus patients with renal insufficiency or failure must be dosed appropriately to compensate. Any patient with a history of VTE should receive an IV dose of TA. TA is not to be used for patients who currently are receiving hormonal/ contraceptive treatments because they already experience high risk for clotting. Nurses should verify the surgical candidate has stopped all nonsteroidal anti-inflammatory drugs, oral anticoagulants, aspirin, and any other anti-inflammatory drugs at least 5-7 before the surgical date; these medications increase bleeding risk and thus counteract the effectiveness of TA (Epocrates, 2016).
During the intraoperative phase of care, estimated blood loss (EBL) must be monitored to determine the effects of TA. TA infusion is compatible with many IV fluids, such as dextrose, Ringer's lactate, and saline, but not with penicillin. For patient safety, nurses must review ordered antibiotics to assure no penicillin or penicillinase drugs are administered (Lexicomp, 2015). Finally, monitoring for hypotension during and after IV TA infusion is necessary due to reports of hypotensive episodes; this is concerning for bleeding as well as increased risk for falling (Haspl et al., 2014). Haspel and colleagues found no significant impact on blood pressure when TA was administered as a slow IV bolus or 30-minute infusion.
Appropriate anticoagulation and early mobilization are key to decreasing risk for a thromboembolic postoperative complication, often related to orthopedic surgery. The clinical nurse must monitor drain output and daily laboratory results, especially the complete blood count. If the nurse notices increased drainage, a change in color and consistency (frank red, sanguineous) of drainage, or a notable drop in hemoglobin, he or she should notify the surgeon immediately. Bleeding still must be monitored carefully in the patient receiving TA, as the half-life of TA is 2-11 hours (Epocrates, 2016). After that period, risk of bleeding is the same as for patients not receiving TA. See Figure 1 for an overview of appropriate management in all three stages of surgery.
Multiple studies have demonstrated the effectiveness of TA in reducing EBL and decreasing the need for blood transfusions following THA (Copeland et al., 2013; Formby, Mack, Newman, Pickett, & Van Blarcum, 2015; Wei & Liu, 2015). Other benefits have been identified. For example, with a decreased need for blood transfusions, a corresponding decrease occurs in costs for transfusion products (Capps, Harris, & Moskal, 2014) as well as staff time administering and monitoring a transfusion.
A study by Capps and colleagues (2014) focused on cost reduction from use of TA in THA. Authors found TA reduced hospital costs and inpatient length of stay following THA. Cost of a transfusion at the study facility was $1,130/unit, with cost of a transfusion reaction after the first unit to be $1,197/reaction. These costs compared favorably to IV TA at $78.28 for the two doses administered in the study. Results also indicated 1,058 patients (19.87%) not receiving TA required a transfusion (cost $300,380). In contrast, only 238 patients (4.39%) receiving TA required transfusion (cost $58,977.95). Findings represented a decrease per patient in complications, costs, and length of stay.
THA can result in high intraoperative EBL and the need for one or more blood transfusions, thus increasing the cost of hospital stay as well as the risk for transfusion reactions and other complications (Haspl et al., 2014). Healthcare providers must be educated in appropriate management of patients who receive TA, including candidate selection, medication effects, and potential complications. Further research is warranted on the preferred and most effective VTE prophylaxis, efficacy of TA in THA, proper dosing, and benefit of oral versus IV routes. In the meantime, nurses must be informed about patient monitoring after TA administration. Patients also must have clear understanding of the rationale for TA use and its potential complications so they can participate actively in their care.
Diana R. Filipek, MSN, RN, APN, is Nurse Practitioner, Trauma Surgery, Cooper University Hospital, Camden, NJ.
Capps, S.G., Harris, R.N., & Moskal, J.T. (2014). Does tranexamic acid reduce blood transfusion cost for primary total hip arthroplasty? A case-control study. The Journal of Arthroplasty, 30(2), 192195.
Clave, A., Dumser, D., Fazilleau, F., & Lacroix, J. (2011). Efficacy of tranexamic acid on blood loss after primary cementless total hip replacement with rivaroxaban thromboprophylaxis: A case-control study in 70 patients. Orthopaedics & Traumatology Surgery & Research, 98(5), 585-590.
Copeland, C., Irwin, A., Jameson, S.S., Khan, S.K., Tate, R.C., & Reed, M.R. (2013). Oral versus intravenous tranexamic acid in enhanced-recovery primary total hip and knee replacement. The Bone & Joint Journal, 95-6(11), 1556-1561.
Duncan, C.M., Gillette, B.P., Jacob, A.K., Sanchez-Sotelo, J., Sierra, R.J., & Smith, H.M. (2014). Venous thromboembolism and mortality associated with tranexamic acid use during total hip and knee arthroplasty. The Journal of Arthroplasty, 30(2), 272-276.
Epocrates. (2016). Tranexamic acid. Retrieved from https://online.epocrates.com/drugs/ 3879/tranexamic-acid
Formby, P.M., Mack, A.W., Newman, M.T., Pickett, A.M., & Van Blarcum, G.S. (2015). The use of intravenous tranexamic acid in patients undergoing total hip or knee arthroplasty: A retrospective analysis at a single military institution. Military Medicine, 180(10), 10871090.
Haspl, M., Oremus, K., Sostaric, S., & Trkulja, V. (2014). Influence of tranexamic acid on postoperative autologous blood retransfusion in primary total hip and knee arthroplasty: A randomized controlled trial. Blood Management, 54(1), 31-41.
Lexicomp. (2015). Tranexamic acid. Retrieved from http://www.wolterskluwercdi.com/ lexicomp-online
Li, J., Tao, L., Wu, L., & Zhou, X. (2013). Do we really need tranexamic acid in total hip arthroplasty? A meta-analysis of nineteen randomized controlled trials. Archives of Orthopedic & Trauma Surgery, 133(7), 1017-1027.
Wei, Z., & Liu, M. (2015). The effectiveness and safety of tranexamic acid in total hip or knee arthroplasty: A meta-analysis of 2720 cases. Transfusion Medicine, 25(3), 151-162.
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|Title Annotation:||Expert Practice|
|Author:||Filipek, Diana R.|
|Date:||Mar 1, 2017|
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