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1.
Intravenous tranexamic acid reduce postoperative drainage and pain after open elbow arthrolysis: A randomized controlled trial
Cui H, Yu S, Ruan J, Sun Z, Li J, Chen S, Fan C
Journal of shoulder and elbow surgery. 2021
Abstract
BACKGROUND Open elbow arthrolysis (OEA), which has become an established treatment for post-traumatic elbow stiffness (PTES), requires complete release of contracture tissue and wide excision of ectopic bone, which results in extensive bleeding. The aim of the present study is to evaluate the efficacy of intravenous tranexamic acid (TXA) on postoperative drainage, calculated blood loss and early clinical outcomes in patients undergoing OEA. METHODS A double-blind, randomized, placebo-controlled trial including 96 patients undergoing OEA was undertaken. Patients received intravenously either 100 mL saline (placebo group, n = 48), or 100 mL saline plus 1 g TXA (TXA group, n = 48) before skin incision. The primary outcome was the drainage volume on postoperative day (POD) 1 to 3. Secondary outcomes included the calculated blood loss, elbow pain score measured by Visual Analog Scale (VAS), elbow function valued by Mayo Elbow Performance Score (MEPS), and rate of complications after OEA. RESULTS Mean total postoperative drainage volume (TXA group: 182 mL vs. placebo group: 214 mL, p = 0.003) and mean calculated total blood loss (TXA group: 582 mL vs. placebo group: 657 mL, p = 0.004) were significantly lower in the TXA group. No transfusions were necessary in either group. Mean VAS pain scores in elbow motion showed marked differences between both groups on POD 1 (TXA: 5 vs. placebo: 6, p = 0.003) and POD 2 (TXA: 4 vs. placebo: 5, p = 0.023), but not in other postoperative time points. No differences were detected in complications, such as pin-related infection, hematoma, new or exacerbation of ulnar nerve symptoms, and recurrent heterotopic ossification. At the 6-month follow-up, no statistical differences were found between the two groups with respect to the elbow functions including range of motion, VAS score and MEPS. CONCLUSION Intravenous administration of TXA significantly decreased the postoperative drainage volume and the total estimated blood loss, and alleviated the elbow pain with motion during early postoperative days in patients undergoing OEA. LEVEL OF EVIDENCE Level I; Randomized Controlled Trial; Treatment Study.
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2.
A novel autologous bone graft substitute comprised of rhBMP6 blood coagulum as carrier tested in a randomized and controlled Phase I trial in patients with distal radial fractures
Durdevic D, Vlahovic T, Pehar S, Miklic D, Oppermann H, Bordukalo-Niksic T, Gavrankapetanovic I, Jamakosmanovic M, Milosevic M, Martinovic S, et al
Bone. 2020;:115551
Abstract
Bone morphogenetic proteins (BMPs) are known to induce new bone formation in vivo but treating trabecular bone defects with a BMP based therapeutic remains controversial. Here, we evaluated the safety and efficacy of a novel Autologous Bone Graft Substitute (ABGS) comprised of recombinant human BMP6 (rhBMP6) dispersed within an autologous blood coagulum (ABC) as a physiological natural carrier in patients with a closed distal radial fracture (DRF). We enrolled 32 patients in a randomized, standard of care (SoC) and placebo (PBO) controlled, double-blinded Phase I First in Human (FiH) clinical trial. ABGS was prepared from peripheral blood as 250 μg rhBMP6/mL ABC or PBO (1 mL ABC containing excipients only) and was administered dorsally via a syringe injection into the fracture site following closed fracture fixation with 3 Kirschner wires. Patients carried an immobilization for 5 weeks and were followed-up for 0 to 26 weeks by clinical examination, safety, serial radiographic analyses and CT. During the 13 weeks follow-up and at 26 weeks post study there were no serious adverse reactions recorded. The results showed that there were no detectable anti-rhBMP6 antibodies in the blood of any of the 32 patients at 13- and 26-weeks following treatment. Pharmacokinetic analyses of plasma from patients treated with ABGS showed no detectable rhBMP6 at any time point within the first 24 hours following administration. The CT image and radiographic analyses score from patients treated with AGBS showed significantly accelerated bone healing as compared to PBO and SoC at 5 and 9 weeks (with high effect sizes and P=0.027), while at week 13 all patients had similar healing outcomes. In conclusion, we show that intraosseous administration of ABGS (250 μg rhBMP6/mL ABC) into the distal radial fracture site demonstrated a good tolerability with no serious adverse reactions as well as early accelerated trabecular bone healing as compared to control PBO and SoC patients.
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3.
The effect of intravenous iron on erythropoiesis in older people with hip fracture
Moppett IK, Rowlands M, Mannings AM, Marufu TC, Sahota O, Yeung J
Age and ageing. 2019
Abstract
BACKGROUND anaemia following hip fracture is common and associated with worse outcomes. Intravenous iron is a potential non-transfusion treatment for this anaemia and has been found to reduce transfusion rates in previous observational studies. There is good evidence for its use in elective surgical populations. OBJECTIVE to examine the impact of intravenous iron on erythropoiesis following hip fracture. DESIGN two-centre, assessor-blinded, randomised, controlled trial of patients with primary hip fracture and no contra-indications to intravenous iron. METHOD the intervention group received three doses of 200 mg iron sucrose over 30 min (Venofer, Vifor Pharma, Bagshot Park, UK) on three separate days. Primary outcome was reticulocyte count at day 7 after randomisation. Secondary outcomes included haemoglobin concentration, complications and discharge destination. Eighty participants were randomised. RESULTS there was a statistically significantly greater absolute final reticulocyte count in the iron group (89.4 (78.9-101.3) x 109 cells l-1 (n = 39) vs. the control (72.2 (63.9-86.4)) x 109 cells l-1 (n = 41); P = 0.019; (mean (95% confidence intervals) of log-transformed data). There were no differences in final haemoglobin concentration (99.9 (95.7-104.2) vs. 102.0 (98.7-105.3) P = 0.454) or transfusion requirements in the first week (11 (28%) vs. 12 (29%); P = 0.899). Functional and safety outcomes were not different between the groups. CONCLUSIONS although intravenous iron does stimulate erythropoiesis following hip fracture in older people, the effect is too small and too late to affect transfusion rates. Trial Registry Numbers: ISRCTN76424792; EuDRACT 2011-003233-34.
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4.
The efficacy and safety of multiple-dose oral tranexamic acid on blood loss following total hip arthroplasty: a randomized controlled trial
Cao G, Huang Q, Huang Z, Zhang S, Luo Z, Lei Y, Zhou Z, Pei F
International Orthopaedics. 2018
Abstract
PURPOSES To explore the efficacy and safety of multiple-dose oral tranexamic acid (TXA) on blood loss following primary total hip arthroplasty (THA). METHODS A total of 152 patients were randomized into three groups to receive 2 g of oral TXA two hours pre-operatively (group A), or another bolus of 2 g of oral TXA four hours post-operatively (group B), or another three boluses of 2 g of oral TXA four, ten, and 16 hours post-operatively (group C). The primary outcomes were total blood loss (TBL), hidden blood loss (HBL), and transfusion rate. The secondary outcomes were haemoglobin (Hb) and haematocrit (Hct) drop, the level of fibrinolysis parameters (fibrin degradation products, D-dimer), and complications (thrombotic diseases, stroke, cardiac infarction, and infection). RESULTS The mean TBL and HBL in group C were lower than those in group A (p < 0.001 and p < 0.001) and group B (p = 0.012 and p = 0.029). The Hb drop on post-operative day one (POD1) and POD3 in group C was lower than those in group A (p < 0.001 and p = 0.029) and group B (p < 0.001 and p = 0.004). The difference was similar regarding Hct drop on POD3 (p < 0.001 and p = 0.014). Moreover, fibrin degradation products and D-dimer in group C were lower than in groups A and B on POD1 and POD3 (p < 0.001 and p < 0.001). The incidence of complications such as venous thromboembolism did not differ significantly among the three groups (p > 0.05). CONCLUSIONS Multiple boluses of oral TXA could further reduce blood loss, Hb and Hct drop, and restrain post-operative fibrinolysis in primary THA without increasing the risk of complications. LEVEL OF EVIDENCE I Therapeutic study.
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5.
Efficacy and safety of topical tranexamic acid in knee arthroplasty
Lopez-Hualda A, Dauder-Gallego C, Ferreno-Marquez D, Martinez-Martin J
Medicina Clinica. 2018;151((11):):431-434
Abstract
INTRODUCTION AND OBJECTIVE Tranexamic acid (TXA) is commonly used to control postoperative blood loss in total knee arthroplasty. In order to avoid adverse effects associated with intravenous administration, topical use has been proposed as an alternative. Our aim was to evaluate the efficacy and safety of topical TXA in total knee arthroplasty. MATERIAL AND METHODS A total of 90 patients scheduled for unilateral total knee arthroplasty were included in a prospective randomised study. All surgeries were performed under spinal anaesthesia, tourniquet and the same postoperative protocol. Patients were allocated to one of the 3 groups according to the application of TXA: group A (n=30) 1g of topical TXA; group B (n=30) 1g of TXA intravenous and in group C or the control group (n=30) no drug was administrated. Parameters related to blood loss and drain outputs were compared between the 3 groups. RESULTS The results revealed that post-operative decrease in haemoglobin level was significantly lower in group A (1.95g/dL) than group B (2.25g/dL) and group C (2.96g/dL), P<.01. Total postoperative blood loss was lower in group A (195mL) than group B (466mL) and group C (718mL), P<.01. There was no significant difference in complications and allogenic blood transfusion rate between the 3 groups. CONCLUSIONS According to the results, topical application of 1g TXA significantly reduced blood loss in patients undergoing total knee arthroplasty more than intravenous or no administration of TXA.
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6.
Tranexamic acid reduces blood loss after primary shoulder arthroplasty: a double-blind, placebo-controlled, prospective, randomized controlled trial
Cvetanovich GL, Fillingham YA, O'Brien M, Forsythe B, Cole BJ, Verma NN, Romeo AA, Nicholson GP
JSES open access. 2018;2(1):23-27
Abstract
Background: Tranexamic acid (TXA) is an antifibrinolytic that has been shown to decrease blood loss and transfusion rates after hip and knee arthroplasty, with only limited evidence to support its use in shoulder arthroplasty. This study was conducted to determine whether intravenous (IV) TXA is more effective than placebo in reducing blood loss after primary total shoulder arthroplasty (TSA). Methods: In this prospective, double-blind, placebo-controlled, randomized clinical trial, patients undergoing primary anatomic and reverse TSA were randomized to receive 1 g of intravenous TXA or a placebo of an equivalent volume of intravenous normal saline administered 10 minutes before the incision. The primary outcome measurement was calculated postoperative blood loss. Secondary outcomes included transfusion rates, weight of hemoglobin loss, hospital length of stay, and thromboembolic events. Results: The study enrolled 110 patients, 2 of whom were excluded because they did not have a postoperative hemoglobin measurement, and the remaining 108 patients (52 for TXA, 56 for placebo) were analyzed. There were no significant differences between TXA and placebo groups in preoperative characteristics. For the primary outcome, the TXA group had significantly lower postoperative blood loss of 1100.9 +/- 367.4 mL compared with 1274.5 +/- 460.0 mL for the placebo group (P = .03). For secondary outcomes, TXA had lower weight of hemoglobin loss compared with placebo (152.2 +/- 57.3 g vs. 178.0 +/- 65.8 g; P = .03). No patients in the TXA or placebo groups required a transfusion. Conclusions: Intravenous TXA reduced blood loss after primary TSA compared with placebo.
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7.
A prospective assessment of outcomes following the use of autologous blood for the management of recurrent temporomandibular joint dislocation
Machon V, Levorova J, Hirjak D, Wisniewski M, Drahos M, Sidebottom A, Foltan R
Oral and Maxillofacial Surgery. 2017;22((1):):53-57
Abstract
PURPOSE The objective of the study was to compare results of treatment for chronic recurrent temporomandibular joint dislocation (CRTMD) by autologous blood injection (ABI) using two different methods of administration (combination intra- and peri-articular, and peri-articular alone). MATERIALS AND METHODS Forty patients diagnosed with CRTMD were randomly divided into two groups of 20 each (A and B). Group A were treated by intra- and peri-articular blood injection, group B were treated by peri-articular injection alone. The follow-up was done at 1, 3, 6, and 12 months. The study assessed presence of dislocations, pain (VAS, 0-10), interincisal mouth opening (IMO), and the presence of sound phenomena. The treatment was considered successful in patients without the persistence of CRTMD symptoms, as well as with a VAS of 0-1. RESULT After 12 months, a beneficial therapeutic effect in group B was seen in 11 patients, while 16 patients from group A had a therapeutic effect. CONCLUSION Intra- and peri-articular ABI is more effective than peri-articular blood application alone in the treatment of CRTMD, although the difference was not statistically significant.
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8.
Double-blind randomized controlled trial: injection of autologous blood in the treatment of chronic patella tendinopathy - a pilot study
Resteghini P, Khanbhai TA, Mughal S, Sivardeen Z
Clinical Journal of Sport Medicine : Official Journal of the Canadian Academy of Sport Medicine. 2016;26((1)):17-23.
Abstract
OBJECTIVE To assess the efficacy of autologous blood injections (ABIs) against saline in patients with chronic recalcitrant patella tendinopathy (PT). DESIGN Double-blind randomized controlled study. SETTING Homerton Hospital Sports Medicine department. PATIENTS Those with a diagnosis of refractory patellar tendinopathy were recruited between March 2010 and March 2012. INTERVENTIONS Using 2 practitioners, patients were randomized to either receive ABIs or saline injections. MAIN OUTCOME MEASURES All patients completed the Short-Form McGill Pain Questionnaire (MPQ), a visual analog scale (VAS), and a Victoria Institute of Sport Assessment for Patella Tendinopathy scale over a 12-month period. RESULTS Twenty-two patients completed the final review at 12 months and were included in the study. Subjects ranged in age from 22 and 61 years and were randomized to 11 in each ABI and saline groups. Autologous blood injection group had a mean duration of symptoms of 16.7 months, whereas that of the saline group was 19.2 months. The saline group mean VAS score was reduced from 7.9 to 4.5 at 1 month (P = 0.003) and 3.3 (P = 0.005) at 1 year. With ABI, the score was reduced from 7.5 to 4.5 (P = 0.005) at 1 month and 3.1 (P = 0.003) at 1 year. Victoria Institute of Sport Assessment for Patella Tendinopathy, MPQ, and VAS scores improved significantly in both groups. CONCLUSIONS This study demonstrated that both the ABI and saline groups experienced a significant improvement in symptoms. However, when the results were compared, there was no statistical difference between the 2 groups. CLINICAL RELEVANCE This research showed that tendon fenestration is an alternative cost-effective treatment for recalcitrant PT.
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9.
Comparison of corticosteroid, autologous blood or sclerosant injections for chronic tennis elbow
Branson R, Naidu K, du Toit C, Rotstein AH, Kiss R, McMillan D, Fooks L, Coombes BK, Vicenzino B
Journal of Science and Medicine in Sport. 2016;20((6):):528-533
Abstract
OBJECTIVES To compare three different ultrasound-guided injections for chronic tennis elbow. DESIGN Assessor-blinded, randomized controlled comparative trial. METHODS 44 patients with clinically diagnosed tennis elbow, confirmed by Doppler ultrasound, received under ultrasound guidance, a single corticosteroid injection (n=14), or two injections (separated by 4 weeks) of either autologous blood (n=14) or polidocanol (n=16). Clinical and ultrasound examination was performed at baseline, 4, 12 and 26 weeks. RESULTS Complete recovery or much improvement was greater for corticosteroid injection than autologous blood and polidocanol at 4 weeks (p<0.001, number needed to treat 1 (95% CI 1-2)). In contrast, at 26 weeks corticosteroid was significantly worse than polidocanol (p=0.004, number needed to harm 2 (1-6)). Recurrence after corticosteroid injection was significantly higher than autologous blood or polidocanol (p=0.007, number needed to harm 2 (1-4)). Corticosteroid injection produced greater reduction in tendon thickness and vascularity than autologous blood at 4 weeks only. Compared to autologous blood, polidocanol reduced tendon thickness at 4 and 12 weeks and reduced echogenicity and hyperaemia after 12 or 26 weeks respectively. CONCLUSIONS Injections of corticosteroid cannot be recommended over polidocanol or autologous blood, because despite beneficial short-term effect there were inferior long-term effects. Whether polidocanol or autologous blood injections are effective is unknown, especially as their global effect profiles are not unlike previously reported for wait-and-see.
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10.
Autologous blood injection to treat achilles tendinopathy? A randomized controlled trial
Pearson J, Rowlands D, Highet R
Journal of Sport Rehabilitation. 2012;21((3):):218-24.
Abstract
CONTEXT Achilles tendinopathy is a common and often debilitating condition, and autologous blood injection is a promising treatment option. OBJECTIVE To determine whether autologous blood injection added to standard management was effective in alleviating symptoms of Achilles tendinopathy. DESIGN A prospective randomized controlled trial. SETTING Private sports medicine clinic. PATIENTS 33 patients (18 women, 15 men) of mean age 50 y (SD 9) with 40 cases of Achilles tendinopathy of mean duration of 11 mo (SD 7). INTERVENTION Participants were randomized to blind peritendinous autologous blood injection added to standard treatment (eccentric-loading exercises) or standard treatment alone for 12 wk. MAIN OUTCOME MEASURE Victorian Institute of Sport Assessment for Achilles (VISA-A) score and ratings of discomfort during and after the injection were measured at baseline and 6 and 12 wk. Analytically derived effect-size thresholds of 5 (small) and 15 (moderate) VISA-A units were used as the reference values for clinical inference. RESULTS Improvements in VISA-A of 7.7 units (95%CL: +/- 6.7) and 8.7 units (+/- 8.8) were observed in the treatment and control groups, respectively, at 6 wk relative to baseline, with no clear effect of blood injection. At 12 wk VISA-A score improved to 18.9 units (+/- 7.4) in the treatment group, revealing a blood-injection effect of 9.6 units (+/- 11.5), relative to a comparatively unchanged condition in control (9.4 units; +/- 9.0). Predictors of response to treatment were unremarkable, and a 21% rate of postinjection flare was the only noteworthy side effect. CONCLUSIONS There is some evidence for small short-term symptomatic improvements with the addition of autologous blood injection to standard treatment for Achilles tendinopathy, although double-blinded studies with longer follow-up and larger sample size are required.