Dataset Information

Novel use of tranexamic acid to reduce the need for Nasal Packing in Epistaxis (NoPac) randomised controlled trial: research protocol.

ABSTRACT: INTRODUCTION:Patients presenting to emergency departments (EDs) with epistaxis uncontrolled by subsequent simple first aid measures or application of topical vasoconstrictors will typically undergo anterior nasal packing. Packing is effective, but can be extremely painful and unpleasant and patients usually need hospital admission. Tranexamic acid (TXA) is a cheap, safe, readily available antifibrinolytic agent known to be beneficial in a variety of clinical settings where uncontrolled bleeding may be a problem. Anecdotal evidence suggests that topical TXA may be of value in persistent epistaxis; however, further evaluation is required. METHODS AND ANALYSIS:This is a multicentre, double-blind, parallel group, randomised, controlled trial comparing the use of topical intranasal TXA with indistinguishable placebo in adults presenting to UK EDs with persistent atraumatic epistaxis. Follow-up is at 1?week by structured telephone review. The primary outcome measure is the subsequent need for anterior nasal packing in the ED. Key secondary outcomes include the need for hospital admission, blood transfusion and/or further treatment for epistaxis during the index ED attendance. Recruiting 450 patients will provide 90% power to demonstrate an absolute reduction in packing rate from 95% to 85%. An improvement of this magnitude would be of significant benefit to patients and healthcare providers and justify a change to standard practice. Given the low cost of TXA and its short administration time, a full economic evaluation is not being undertaken. ETHICS AND DISSEMINATION:The study has been approved by the South West-Bristol Research Ethics Committee (reference 17/SW/0010). We aim to publish the findings in a high impact, international peer-reviewed journal. Results will also be shared with the Hereditary Haemorrhagic Telangiectasia foundation and telangiectasia UK for dissemination through appropriate related forums. TRIAL REGISTRATION NUMBER:ISRCTN34153772 and EudraCT No: 2016-001530-10.

SUBMITTER: Reuben A

PROVIDER: S-EPMC6398761 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Novel use of tranexamic acid to reduce the need for Nasal Packing in Epistaxis (NoPac) randomised controlled trial: research protocol.

Reuben Adam A Appelboam Andrew A Barton Andy A Vickery Patricia Jane PJ Body Richard R Hilton Malcolm M Coppell Jason J Ewings Paul P

BMJ open 20190215 2

<h4>Introduction</h4>Patients presenting to emergency departments (EDs) with epistaxis uncontrolled by subsequent simple first aid measures or application of topical vasoconstrictors will typically undergo anterior nasal packing. Packing is effective, but can be extremely painful and unpleasant and patients usually need hospital admission. Tranexamic acid (TXA) is a cheap, safe, readily available antifibrinolytic agent known to be beneficial in a variety of clinical settings where uncontrolled b ...[more]

PMID: 30772866

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Project description:BackgroundEpistaxis is the most common emergent consultation to otolaryngology-head & neck surgery (OHNS) and with 60% of the population having experienced an episode and 1.6 in 10,000 requiring hospitalization in their lifetime. In preliminary studies Floseal® (Baxter, USA) Hemostatic Matrix has shown efficacy in up to 80% of persistent anterior epistaxis. We sought to evaluate the clinical efficacy and cost-effectiveness of Floseal® (Baxter, USA) compared to traditional nasal packing for persistent epistaxis.MethodsA prospective, randomized controlled trial was conducted on all adult patients consulted to the OHNS service at the tertiary referral centers of the University of Alberta Hospital and Royal Alexandra Hospital for persistent epistaxis. Patients were randomized to the Floseal® (Baxter, USA) or traditional packing study arms. Our main clinical outcome measures were: 1) Hemostasis directly following treatment and at 48 h post-treatment, and 2) self-reported patient comfort at 48 h post-treatment. Further, trial data was used for a formal cost-effectiveness analysis to determine incremental cost-effectiveness ratio (ICER). Univariate sensitivity analysis and uncertainty analysis were performed.ResultsThere were no significant differences between groups for initial hemostasis (76.9% vs. 84.6%, p = 1.000) or, hemostasis at 48 h (76.9% vs. 69.2%, p = 1.000), requirement for admission (15.4% vs. 46.1%, p = 0.2016) or 30-day re-presentation rates (15.4% vs. 46.1%, p = 0.2016). Floseal® (Baxter, USA) was superior for decreased pain during placement (2.42 vs. 7.77, p = 0.0022), treatment (0.50 vs. 4.46, p = 0.0007) and removal (0 vs. 3.85, p = 0.0021). Floseal® (Baxter, USA) provides an average $1567.61 per patient savings from the single-payer system point of view and has an ICER of - $11,891 per re-bleed prevented (95% CI: -$37,658 to +$473). Uncertainty analysis shows that Floseal® has >90% chance of not only being cost-effective, but the dominant (preferred) treatment.ConclusionsFloseal® (Baxter, USA) was demonstrated to be an effective, comfortable and cost-effective alternative treatment of persistent epistaxis when compared to traditional packing methods for patients referred to OHNS with a normal coagulation profile.Trial registrationTrial registration number: NCT02488135 . Date registered: June 26, 2015.

Project description:IntroductionRadical abdominal surgery is part of the standard treatment for women with advanced gynaecological carcinoma. The surgery often leads to intraoperative blood loss frequently exceeding 1000 mL. Approximately 50% of women undergoing radical surgery require blood transfusions. Perioperative blood transfusions have been shown to increase the risk of postoperative complications, delayed wound healing, increased length of stay, increased postoperative morbidity and mortality. Previous studies have demonstrated an association between perioperative anaemia and surgical morbidity and mortality. By reducing transfusions and improving recovery from surgery, preoperative diagnostic and management of perioperative anaemia is a great opportunity to optimise postoperative patient outcome.Methods and analysisThis is a single-blind, monocentre, randomised trial with four parallel groups (three therapeutic groups and one control group without treatment according to current standards of care) conducted in women undergoing radical gynaecological surgery. The primary study objective is to determine the effect of perioperative treatment with either intravenous iron, tranexamic acid or with a combination of both medicines on the reduction of intraoperative and postoperative red blood cell transfusions in gynaecological carcinoma patients. A total of N=126 women with gynaecological carcinoma will be recruited at the University Hospital Basel, Department of Gynaecology. Blood parameters will be measured at the recruitment, prior to surgery, 2 days after surgery and on the 21st-28th day after surgery. Recruitment started in August 2021.Ethics and disseminationThe study will be performed according to the guidelines of the Declaration of Helsinki and is approved by the Ethics Committee for Northwest and Central Switzerland in Basel (EKNZ Protocol ID 2020-01194). The results of this study will be published and presented in various scientific forums.Trial registration numberNCT03792464.

Project description:BackgroundGlanzmann thrombasthenia is a rare bleeding disorder due to defects in the glycoprotein Ilb/IIIa complex present on the platelet membrane. The most common mode of treatment for this disorder is platelet transfusion. However, scientific evidence does state that repeated transfusions could lead to auto immunization making transfusions ineffective.Aim and objectiveTo describe the use of a novel technique of soft splint with tranexamic acid paste to stop oral bleeding in a patient with Glanzmann thrombasthenia (GT).Case descriptionA 7-year-old female patient with a known history of GT was referred to the pediatric department. The chief complaint of the patient revealed a history of spontaneous bleeding from the oral cavity. The patient required multiple teeth extractions due to severely carious teeth. History revealed that the patient was admitted to the hospital (casualty) three times within 1 month due to a similar complaint leading to hypovolemic shock. Several transfusion procedures were done to stop the spontaneous bleeding. To stop the intraoral bleeding without transfusions, a novel method of using a soft splint with tranexamic acid paste (500 mg tablet crushed and mixed with saline) in the area of spontaneous bleeding was employed with a successful follow-up of 7 months.ConclusionSoft splint with the tranexamic acid paste can serve as an effective method of treatment for patients with spontaneous oral bleeding due to medical conditions like GT.Clinical relevanceThis case report highlights the need for awareness among all the healthcare providers about the importance of regular dental visits. The healthcare providers also need to emphasize the same to all patients with medical conditions to avoid such life-threatening situations.How to cite this articleBhavyaa R, Vignesh KC, Muthu MS, et al. Glanzmann Thrombasthenia: Use of the Soft Splint with Tranexamic Acid Paste to Reduce Spontaneous Oral Bleeding. Int J Clin Pediatr Dent 2021;14(4):580-585.

Dataset Information

Novel use of tranexamic acid to reduce the need for Nasal Packing in Epistaxis (NoPac) randomised controlled trial: research protocol.

Publications

Novel use of tranexamic acid to reduce the need for Nasal Packing in Epistaxis (NoPac) randomised controlled trial: research protocol.

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