Orthopaedic surgeons are using tranexamic acid (TXA) fairly routinely to reduce blood loss in patients undergoing a variety of orthopaedic procedures, including hip and knee arthroplasty, spine surgery, shoulder arthroplasty, and lower-extremity fracture surgery. [1-5]
Derek J. Cuff, MD, from Suncoast Orthopaedic Surgery and Sports Medicine, in Venice, Florida, is one of the many surgeons in the US who has used TXA with elective anatomic and reverse shoulder arthroplasty patients, with good results. But TXA use in surgery for an increasingly common shoulder injury – proximal humerus fractures – has not been studied. So, Dr. Cuff wanted to know: Would TXA also reduce intraoperative and postoperative blood loss in these patients?
There’s good reason to ask the question: Proximal humerus fractures account for approximately 6% of fractures and are third most-common in adults age 65 and older, behind only wrist fractures and femoral neck fractures. [6,7] Yet the effectiveness of TXA in patients undergoing surgery for proximal humerus fractures is unknown.
Now, with a prospective, randomized study from Dr. Cuff and investigators from the Foundation for Orthopaedic Research and Education, we have some insight into this issue: In their study, TXA was found to be safe and effective in reducing total blood loss and preoperative-to-postoperative hemoglobin in patients undergoing either open reduction and internal fixation (ORIF) or reverse shoulder arthroplasty (RSA) for a proximal humerus fracture.
As a result, Dr. Cuff said he uses TXA not only with his elective shoulder arthroplasty patients, but also with his proximal humerus fracture patients who undergo surgery, unless contraindicated.
Between April 2015 and April 2019, the researchers enrolled and randomized 101 patients with proximal humerus fractures to receive either 1 gram of TXA intravenously (IV) or 20 mL of IV normal saline solution just before skin incision. Dr. Cuff acknowledged a lack of consensus on the optimum dose and route of administration of TXA. “There are many different dosing schedules that have been used, and many have shown no difference in using 1 versus 2 doses or topical versus IV,” he said. “The 1 gram IV dose prior to incision is the same dosing schedule we have used for elective shoulder arthroplasty, so we chose to use it for fracture surgery as well.”
In the treatment group (n=53), 30 patients underwent ORIF and 23 underwent RSA. Twenty-seven patients from the control group (n=48) underwent ORIF and 21 underwent RSA. The injury pattern and the patient’s age were the deciding factors for which procedure Dr. Cuff would recommend:
- ORIF was recommended to patients under age 65 who had a displaced 2-, 3-, or 4-part proximal humerus fracture and to patients age 65 and over who had a displaced 3-part fracture with no comminution of the greater tuberosity.
- RSA was recommended for patients age 65 and over who had a displaced 3-part fracture with comminution of the greater tuberosity or a 4-part fracture.
All patients underwent surgery 1 to 2 weeks after injury.
The researchers calculated total blood loss for each patient based on the amount of blood in the suction cannisters right after surgery (minus irrigation fluid used during the procedure) plus 24-hour output from the drain placed at wound closure. They also compared preoperative hemoglobin levels with POD1 hemoglobin levels, with the threshold for a blood transfusion being a hemoglobin level less than 8 g/dL.
In line with studies of TXA use in other orthopaedic patient populations, patients in this study who received TXA had less average intraoperative blood loss, less postoperative drain output, and less total blood loss than patients in the control group (P<0.0001 for all 3 measures of blood loss). In addition, patient in the ORIF TXA group and the RSA TXA group had less average total blood loss than patients in the control group (P<0.0001).
Patients in the TXA group also had a smaller average preoperative-to-postoperative change in hemoglobin level than patients in the control group (P<0.0001). That was also of the ORIF TXA and RSA TXA groups compared with controls as well. (P<0.0001).
None of the study patients needed a transfusion and none of the patients experienced a thromboembolic event during and after surgery.
The study findings were not surprising, Dr. Cuff said, based on the literature and his own experience with TXA in shoulder arthroplasty patients. “TXA has been shown to reduce blood loss in other orthopaedic conditions,” he said. “However, it had not been investigated in proximal humeral fractures in a randomized, prospective fashion as we did in this study.”
This study adds to the body of evidence on the use of TXA in orthopaedic surgery, with the results indicating that “it is a safe and effective treatment to help reduce blood loss when operating on proximal humeral fractures,” Dr. Cuff said.
Cuff DJ, Simon P, Gorman II RA. Randomized prospective evaluation of the use of tranexamic acid and effects on blood loss for proximal humeral fracture surgery. J Shoulder Elbow Surg. 2020 Aug;29(8):1627-1632. doi: 10.1016/j.jse.2020.04.016. Epub 2020 Jun 9.
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- Cheriyan T, Maier SP II, Bianco K, Slobodyanyuk K, Rattenni RN, Lafage V, et al. Efficacy of tranexamic acid on surgical bleeding in spine surgery: a meta-analysis. Spine J 2015;15:752-61.
- Georgiadis AG, Muh SJ, Silverton CD, Weir RM, Laker MW. A prospective double-blind placebo-controlled trial of topical tranexamic acid in total knee arthroplasty. J Arthroplasty 2013;28(Suppl):78-82.
- McCormack PL. Tranexamic acid: a review of its use in the treatment of hyperfibrinolysis. Drugs 2012;72:585-617.
- Xiao C, Zhang S, Long N, Yu W, Jiang Y. Is intravenous tranexamic acid effective and safe during hip fracture surgery? An updated meta-analysis of randomized controlled trials. Arch Orthop Trauma Surg 2019;139:893-902.
- Court-Brown, CM, Caesar, B. Epidemiology of adult fractures: a review. Injury. 2006;37(8):691–697. doi:10.1016/j.injury.2006.04.130.
- Calvo, E, Morcillo, D, Foruria, AM, Redondo-Santamaría, E, Osorio-Picorne, F, Caeiro, JR. Nondisplaced proximal humeral fractures: high incidence among outpatient-treated osteoporotic fractures and severe impact on upper extremity function and patient subjective health perception. J Shoulder Elbow Surg. 2011;20(5):795–801.