scholarly journals Study protocol for a multicentre, 2×2 factorial, randomised, controlled trial evaluating the interest of intravenous iron and tranexamic acid to reduce blood transfusion in hip fracture patients (the HiFIT study)

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e040273
Author(s):  
Sigismond Lasocki ◽  
Thibault Loupec ◽  
Elsa Parot-Schinkel ◽  
Bruno Vielle ◽  
Marc Danguy des Déserts ◽  
...  
Keyword(s):  
Hip Fracture ◽  
Blood Transfusion ◽  
Tranexamic Acid ◽  
Controlled Trial ◽  
Intravenous Iron ◽  
Good Clinical Practice ◽  
Allogenic Blood Transfusion ◽  
Transfusion Rate ◽  
Packed Red Blood Cells ◽  
Allogenic Blood

IntroductionBlood transfusion and anaemia are frequent and are associated with poor outcomes in patients with hip fracture (HF). We hypothesised that preoperative intravenous iron and tranexamic acid (TXA) may reduce the transfusion rate in these patients.Methods and analysisThe HiFIT study is a multicentre, 2×2 factorial, randomised, double-blinded, controlled trial evaluating the effect of iron isomaltoside (IIM) (20 mg/kg) vs placebo and of TXA (intravenously at inclusion and topically during surgery) versus placebo on transfusion rate during hospitalisation, in patients undergoing emergency surgery for HF and having a preoperative haemoglobin between 95 and 130 g/L. 780 patients are expected. The primary endpoint is the proportion of patients receiving an allogenic blood transfusion of packed red blood cells from the day of surgery until hospital discharge (or until D30 if patient is still hospitalised). Enrolment started on March 2017 in 11 French hospitals. The study was stopped between July 2017 and August 2018 (because of investigation of serious AEs with IIM in Spain) and slowed down since March 2020 (COVID-19 crisis). The expected date of final follow-up is May 2022. Analyses of the intent-to-treat and per-protocol populations are planned.Ethics and disseminationThe HiFIT trial protocol has been approved by the Ethics Committee of Comité de Protection des Personnes Ouest II and the French authorities (ANSM). It will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals. The HiFIT trial will be the largest study evaluating iron and TXA in patients with HF.Trial registration numberclinicalTrials.gov identifier: NCT02972294; EudraCT Number 2016-003087-40.

scholarly journals Low blood transfusion rate after implementation of tranexamic acid for fast- track hip- and knee arthroplasty. An observational study of 5205 patients

2021 ◽  
Vol 87 (1) ◽  
pp. 9-16
Author(s):  
Yoeri Bemelmans ◽  
Emil Van Haaren ◽  
Bert Boonen ◽  
Roel Hendrickx ◽  
Martijn Schotanus
Keyword(s):  
Blood Transfusion ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Knee Arthroplasty ◽  
Allogenic Blood Transfusion ◽  
Transfusion Rate ◽  
Allogenic Blood ◽  
Estimated Blood Loss ◽  
Duration Of Surgery ◽  
Hip And Knee Arthroplasty

The purpose of this study was to retrospectively evaluate the efficacy of a tranexamic acid (TXA) perioperative protocol for primary hip- and knee arthroplasty, in terms of allogenic blood transfusion rates. A retrospective cohort study was conducted and included all primary hip and knee arthroplasty procedures in the period of 2014-2019. Patients who underwent surgery due to trauma or revision were excluded. A total amount of 5205 patients were eligible for inclusion. Two equal and weight depending doses of TXA were given, preoperative as an oral dose and intravenously at wound closure. The primary outcome was blood transfusion rate. Further analysis on patient characteristics (e.g. age, gender), blood loss, perioperative haemoglobin (Hb) levels and complication/readmission rate was performed. A total of 49 (0.9%) patients received perioperative allogenic blood transfusions. Mean age, distribution of gender, body-mass index, American Society of Anaesthesiologists score, duration of surgery, type of arthroplasty, estimated blood loss, perioperative Hb levels and length of stay were statistically significant different between transfused and not-transfused patients. The incidence of thromboembolic adverse events (e.g. deep vein thrombosis/lung embolism) was 0.5%. Low blood transfusion rate was found after implementation of a standardized perioperative TXA protocol for primary hip and knee arthroplasty.

scholarly journals Efficacy and Cost Effectiveness of Universal Preoperative Iron Studies in Total Hip and Knee Arthroplasty

2021 ◽  
Author(s):  
Viju Daniel Varghese ◽  
David Liu ◽  
Donald Ngo ◽  
Suzanne Edwards
Keyword(s):  
Blood Transfusion ◽  
Knee Arthroplasty ◽  
Universal Screening ◽  
Intravenous Iron ◽  
Allogenic Blood Transfusion ◽  
Transfusion Rate ◽  
Allogenic Blood ◽  
Total Hip ◽  
Hip And Knee Arthroplasty ◽  
The Difference

Abstract Background Prevalence of anaemia in patients planned for total hip and knee arthroplasty is about 20%. Optimising preoperative haemoglobin levels by iron supplementation has been shown to decrease transfusion rates, complications and associated morbidity. The need for universal screening with iron studies of all elective arthroplasty patients is not clearly defined at present. Methods Retrospective review of 2 sequential cohorts of patients undergoing primary hip or knee arthroplasty by a single surgeon at a single centre between January 2013 and December 2017. The first group of patients underwent pre-operative iron studies only if found to be anaemic, with a haemoglobin below 12g/dL. From January 2015 all patients irrespective of the presence of anaemia were screened with a complete iron profile before surgery. Patients with a confirmed iron deficiency were administered with intravenous iron prior to surgery. The 2 cohorts were compared with regards to blood transfusion rate post-operatively and cost efficiency for universal screening with iron studies. Results There was a net decrease in allogenic blood transfusion rate from 4.76–2.92% when universal iron studies were introduced but the difference was not statistically significant. Obtaining universal pre-operative iron studies is cost neutral with the price of allogenic blood transfusion in a similar cohort. We also diagnosed 5 patients with occult malignancies. Conclusions Universal screening with pre-operative iron studies and iron infusion in elective arthroplasty patients may reduce allogenic blood requirements and is cost neutral. An additional benefit is the potential to diagnose asymptomatic malignancies. Further studies are required to show the true benefit of universal pre-operative iron screening.

scholarly journals Efficacy and cost-effectiveness of universal pre-operative iron studies in total hip and knee arthroplasty

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Viju Daniel Varghese ◽  
David Liu ◽  
Donald Ngo ◽  
Suzanne Edwards
Keyword(s):  
Blood Transfusion ◽  
Knee Arthroplasty ◽  
Universal Screening ◽  
Intravenous Iron ◽  
Allogenic Blood Transfusion ◽  
Transfusion Rate ◽  
Allogenic Blood ◽  
Total Hip ◽  
Hip And Knee Arthroplasty ◽  
The Difference

Abstract Background The prevalence of anaemia in patients planned for total hip and knee arthroplasty is about 20%. Optimising pre-operative haemoglobin levels by iron supplementation has been shown to decrease transfusion rates, complications and associated morbidity. The need for universal screening with iron studies of all elective arthroplasty patients is not clearly defined at present. Methods Retrospective review of 2 sequential cohorts of patients undergoing primary hip or knee arthroplasty by a single surgeon at a single centre between January 2013 and December 2017. The first group of patients underwent pre-operative iron studies only if found to be anaemic, with a haemoglobin below 12g/dl. From January 2015, all patients irrespective of the presence of anaemia were screened with a complete iron profile before surgery. Patients with a confirmed iron deficiency were administered with intravenous iron prior to surgery. The 2 cohorts were compared with regard to blood transfusion rate post-operatively and cost efficiency for universal screening with iron studies. Results There was a net decrease in the allogenic blood transfusion rate from 4.76 to 2.92% when universal iron studies were introduced but the difference was not statistically significant. Obtaining universal pre-operative iron studies is cost neutral with the price of allogenic blood transfusion in a similar cohort. We also diagnosed 5 patients with occult malignancies. Conclusions Universal screening with pre-operative iron studies and iron infusion in elective arthroplasty patients may reduce allogenic blood requirements and is cost neutral. An additional benefit is the potential to diagnose asymptomatic malignancies. Further studies are required to show the true benefit of universal pre-operative iron screening.

scholarly journals Efficacy and Safety of Tranexamic Acid in Bimaxillary Orthognathic Surgery

2020 ◽  
Vol 28 (2) ◽  
pp. 94-104
Author(s):  
Liang Sun ◽  
Rui Guo ◽  
Yi Feng
Keyword(s):  
Blood Transfusion ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Orthognathic Surgery ◽  
Operation Time ◽  
Controlled Trials ◽  
Allogenic Blood Transfusion ◽  
Intraoperative Blood Loss ◽  
Irrigation Fluid ◽  
Allogenic Blood

Background: Tranexamic acid (TXA) has been widely used during craniofacial and orthognathic surgery (OS). However, results of the literature are inconsistent due to specific type of surgery and a small sample of studies. The purpose of this study was to evaluate the role of TXA in bimaxillary OS. Methods: We performed a comprehensive literature search of PubMed, Cochrane Central Register of Controlled Trials, and EMBASE to identify randomized controlled trials (RCTs) that compared effect of TXA on bimaxillary OS with placebo. Outcomes of interests included intraoperative blood loss, allogenic transfusion, operation time, and volume of irrigation fluid. Random effects models were chosen considering that heterogeneity between studies was anticipated, and I 2 statistics were used to test for the presence of heterogeneity. Results: Totally 6 RCTs were identified. Tranexamic acid resulted in significantly reduced intraoperative blood loss (weighted mean difference [WMD] = −264.82 mL; 95% CI: −380.60 to −149.04 mL) and decreased amounts of irrigation fluid (WMD = −229.23 mL; 95% CI: −399.63 to −58.83 mL). However, TXA had no remarkable impact on risk of allogenic blood transfusion (pooled risk ratio = 0.50; 95% CI: 0.20-1.23), operation time (WMD = −8.71 min; 95% CI: −20.98 to 3.57 min), and length of hospital stay (WMD = −0.24 day; 95% CI: −0.62 to 0.14 day). No TXA-associated severe adverse reactions or complications were observed. Conclusions: Currently available meta-analysis reveals that TXA is effective in decreasing intraoperative blood loss; however, it does not reduce the risk of allogenic blood transfusion in bimaxillary OS.

Efficacy and safety of tranexamic acid in hip fracture surgery: A comparative study of 613 patients

2021 ◽  
pp. 175045892110020
Author(s):  
Mutaz AlSumadi ◽  
Aatif Mahmood ◽  
David Whittam ◽  
Lara Kharma ◽  
Rami Ashour ◽  
...  
Keyword(s):  
Hip Fracture ◽  
Blood Transfusion ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Thromboembolic Events ◽  
Allogenic Blood ◽  
Hip Fracture Surgery ◽  
Estimated Blood Loss ◽  
Fracture Surgery ◽  
Postoperative Haemoglobin

Background Blood loss is a major concern in the frail elderly patient undergoing hip fracture surgery. The objective of this study was to investigate the efficacy of tranexamic acid in reducing blood loss and allogenic blood transfusions. The study also investigated the safety profile by comparing rates of thromboembolic events, Methods A total of 613 patients with hip fractures were included in the study. Patients received 1g of tranexamic acid on induction of anaesthesia. Postoperative haemoglobin was measured on day one. Blood loss was calculated, and blood transfusion was recorded. Results Tranexamic acid use resulted in a higher mean postoperative haemoglobin (110.3 ± 15.9 vs 106.8 ± 16.2; p = 0.023) and reduced mean estimated blood loss (571.3 ± 150.4 vs 678.3 ± 201.2; p = 0.001). There was also a significantly reduced number of transfusions in tranexamic acid group (13% vs 28%; p = 0.002). There was no difference in rates of deep vein thrombosis (4 vs 3; p = 0.98) or pulmonary embolism (2 vs 2; p = 1). Conclusion The use of tranexamic acid is effective in reduction of blood loss and rates of blood transfusion, without an apparent increase in adverse thromboembolic events.

Effect of tranexamic acid use on blood loss and thromboembolic risk in hip fracture surgery: systematic review and meta-analysis

2017 ◽  
Vol 28 (1) ◽  
pp. 3-10 ◽  
Author(s):  
Dinnish Baskaran ◽  
Syed Rahman ◽  
Yousuf Salmasi ◽  
Saied Froghi ◽  
Onur Berber ◽  
...  
Keyword(s):  
Hip Fracture ◽  
Blood Transfusion ◽  
Blood Loss ◽  
Meta Analysis ◽  
Total Blood Loss ◽  
Allogenic Blood Transfusion ◽  
Total Blood ◽  
Allogenic Blood ◽  
Transfusion Requirements ◽  
Duration Of Surgery

Introduction: Intravenous tranexamic acid (IV TXA) is a recognised pharmaceutical intervention utilised to minimise blood loss and allogenic blood transfusion. However, the use of IV TXA in hip fracture surgery remains inconclusive. We conducted a meta-analysis to investigate the role of TXA in operative hip fracture management on operative and total blood loss, allogenic blood transfusion requirements and impact on venous thromboembolic (VTE) event incidence. Methods: A systematic computerised literature search of PubMed, Medline, Embase, Ovid, The Cochrane Controlled Trials Register, Trip and Google was conducted. We reviewed the efficacy of IV TXA on perioperative blood loss, total blood loss, pre- and postoperative haemoglobin differences, duration of surgery, allogenic blood transfusion requirements and VTE events. Results: 8 studies were eligible including 6 randomised control trials and 2 cohort studies. Patients receiving IV TXA had reduced mean total blood loss of 442.9 mls (95% CI, 426.5-459.3; p<0.00001), reduced operative blood loss of 88.5 mls (95% CI, 59.9-117.2; p<0.00001), a decrease in the need for allogenic blood transfusion (OR 0.37; 95% CI, 0.26-0.53; p<0.00001) and a reduction in pre- and postoperative haemoglobin difference (p = 0.013.) There was no significant increase in VTE risk (OR 1.59; 95% CI 0.67-3.75; p>0.29) or significant difference on duration of surgery seen with IV TXA usage (p>0.06). Conclusions: Our review demonstrated the efficacy of IV TXA in minimising perioperative, reducing total blood loss and lowering the necessity for allogenic blood transfusions with no significant increased risk in VTE events.

scholarly journals Intraoperative cell salvage use reduces the rate of perioperative allogenic blood transfusion in patients undergoing periacetabular osteotomy

2019 ◽  
Vol 6 (3) ◽  
pp. 277-283 ◽  
Author(s):  
Michael van der Merwe ◽  
Nicholas J Lightfoot ◽  
Jacob T Munro ◽  
Matthew J Boyle
Keyword(s):  
Blood Transfusion ◽  
Blood Loss ◽  
Periacetabular Osteotomy ◽  
Allogenic Blood Transfusion ◽  
Transfusion Rate ◽  
Cell Salvage ◽  
Blood Conservation ◽  
Allogenic Blood ◽  
Significant Difference ◽  
Clinical Records

Abstract Blood loss during periacetabular osteotomy (PAO) is variable, with losses ranging from 100 to 3900 ml in published series. Perioperative allogenic blood transfusion is frequently utilized although is associated with significant risk of morbidity. Cell salvage (CS) is a common blood conservation tool; however, evidence supporting its use with PAO is lacking. Our aim was to assess whether CS affects perioperative allogenic blood transfusion rate in patients undergoing PAO. The clinical records of 58 consecutive PAOs in 54 patients (median age 24.7 years, interquartile range 17.8–29.4 years) performed by a single surgeon between 1 January 2016 and 30 April 2018 were reviewed. Autologous blood pre-donation and surgical drains were not used. Due to variable technician availability, CS was intermittently used during the study period. PAOs were allocated into a CS group or no cell salvage group (NCS group), according to whether an intraoperative CS system was used. There was no significant difference in patient age, gender, body mass index, dysplasia severity, regional anesthetic technique, tranexamic acid administration, surgical duration or estimated blood loss (all P > 0.05) between the two groups. The CS group had a lower preoperative hemoglobin compared to the NCS group (median, 13.4 g/dl versus 14.4 g/dl, P = 0.006). The incidence of allogenic blood transfusion was significantly lower in the CS group compared to the NCS group (2.5% versus 33.3% patients transfused, P = 0.003). Multivariate modeling showed CS use to be protective against allogenic blood transfusion (P = 0.003), with an associated 80-fold reduction in the odds of transfusion (odds ratio, 0.01; 95th% CI, 0–0.57). To our knowledge, this is the first study to assess the effect of CS use on allogenic transfusion rate in patients undergoing PAO. Our results demonstrate CS to be a mandatory component of blood conservation for all patients undergoing PAO.

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