Study protocol: haemostatic efficacy and safety of preemptive antifibrinolysis with multidose intravenous tranexamic acid in elderly hip fracture patients: design of a prospective randomised controlled trial

IntroductionHip fracture surgery is often associated with substantial blood loss and a high allogeneic blood transfusion (ABT) rate. Preoperative hidden blood loss (HBL) has been observed clinically but there is little evidence for the efficacy of tranexamic acid (TXA) in controlling preoperative HBL. We designed a randomised controlled trial to evaluate the efficacy of preemptive antifibrinolysis with multidose intravenous TXA (IV-TXA) in reducing preoperative HBL in elderly patients with hip fractures.Methods and analysisThis is a prospective, randomised, placebo-controlled clinical trial. Patients older than 65 years diagnosed with primary unilateral femoral neck fracture or intertrochanteric fracture will be randomly assigned to group A (receiving 100 mL of intravenous normal saline every 12 hours preoperatively and 1.5 g of IV-TXA every 12 hours postoperatively for 3 days) or group B (receiving 1.5 g of IV-TXA every 12 hours preoperatively and 1.5 g of IV-TXA every 12 hours postoperatively for 3 days). The primary outcomes will be the hidden blood loss, haemoglobin decrease and ABT rate. The secondary outcomes include the levels of inflammatory factors (such as C reactive protein) and coagulation and fibrinolysis parameters (such as D-dimer). Other outcomes such as injury time, length of stay and hospitalisation expenses will also be compared between groups.Ethics and disseminationThis study has been approved by the Ethics Committee of the First Affiliated Hospital of Chongqing Medical University. The findings of the study will be disseminated through peer-reviewed journals and conference presentations.Trial registration numberChiCTR2100045960.

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Enhanced interdisciplinary care improves self-care ability and decreases emergency department visits for older Taiwanese patients over 2 years after hip-fracture surgery: A randomised controlled trial

International Journal of Nursing Studies ◽

10.1016/j.ijnurstu.2015.12.005 ◽

2016 ◽

Vol 56 ◽

pp. 54-62 ◽

Cited By ~ 9

Author(s):

Yea-Ing L. Shyu ◽

Jersey Liang ◽

Ming-Yueh Tseng ◽

Hsiao-Juan Li ◽

Chi-Chuan Wu ◽

...

Keyword(s):

Emergency Department ◽

Hip Fracture ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Self Care ◽

Emergency Department Visits ◽

Interdisciplinary Care ◽

Hip Fracture Surgery ◽

Randomised Controlled ◽

Fracture Surgery

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Is it feasible to conduct a definitive multi-centre randomised controlled trial of intraoperative cell salvage and autotransfusion compared to standard care in patients undergoing hip fracture surgery?

http://isrctn.com/ ◽

10.1186/isrctn15945622 ◽

2019 ◽

Author(s):

Katy Mironov

Keyword(s):

Hip Fracture ◽

Randomised Controlled Trial ◽

Standard Care ◽

Controlled Trial ◽

Cell Salvage ◽

Hip Fracture Surgery ◽

Intraoperative Cell Salvage ◽

Randomised Controlled ◽

Fracture Surgery

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Effect of single dose intravenous tranexamic acid on blood loss in tangential excision of burn wounds — a double blind randomised controlled trial

Burns ◽

10.1016/j.burns.2021.08.021 ◽

2021 ◽

Author(s):

Ajai K.S. ◽

Parmod Kumar ◽

Mohsina Subair ◽

Ramesh Kumar Sharma

Keyword(s):

Single Dose ◽

Randomised Controlled Trial ◽

Blood Loss ◽

Tranexamic Acid ◽

Controlled Trial ◽

Double Blind ◽

Burn Wounds ◽

Randomised Controlled

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Comparison of regional with general anaesthesia on postoperative delirium (RAGA-delirium) in the older patients undergoing hip fracture surgery: study protocol for a multicentre randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2017-016937 ◽

2017 ◽

Vol 7 (10) ◽

pp. e016937 ◽

Cited By ~ 11

Author(s):

Ting Li ◽

Joyce Yeung ◽

Jun Li ◽

Yan Zhang ◽

Teresa Melody ◽

...

Keyword(s):

Clinical Trial ◽

Hip Fracture ◽

General Anaesthesia ◽

Older Patients ◽

Postoperative Delirium ◽

Controlled Trial ◽

Controlled Clinical Trial ◽

Hip Fracture Surgery ◽

Randomised Controlled ◽

Fracture Surgery

IntroductionPostoperative delirium (POD) is a common serious postoperative complication especially in older people and is associated with increased mortality, morbidity and healthcare costs. There is no clear consensus which anaesthesia is associated with less incidence of POD for older patients. We aim to assess whether regional anaesthesia results in lower incidence of POD comparing with general anaesthesia (GA) among older patients undergoing hip fracture surgery.Methods and analysisRAGA-delirium is a pragmatic, multicentre, prospective, parallel grouped, randomised controlled clinical trial comparing RA or GA for hip fracture surgery. A total of 1000 patients who are 65 years or over and who are having planned hip fracture surgery in nine clinical trial centres of China will be randomised in a 1:1 ratio to receive either anaesthesia for the surgery. The primary endpoint will be the incidence of POD at day 7. The secondary endpoints will be the subtype, severity and duration of delirium, postoperative acute pain score, incidence of other postoperative non-delirium complications, quality of life and cost-effective outcomes. Randomisation will be performed at the patient level using computer-generated assignment. Outcome assessors will be blinded from intervention assignment. Assessments will be conducted before surgery, intraoperatively, postoperatively, during the hospital stay, at 30-day, 6-month and 1-year postoperative intervals.Potential impact of studyThis study will provide clinical evidence with a more robust methodology to help anaesthetists in selecting appropriate anaesthesia for older patients with high risk for POD. At the era of increasing emphasis on delirium prevention, this trial has the potential to inform the future national guideline to reduce POD.Ethics and disseminationEthical approved by the local institutional review board. Trial results will be presented at national and international academic conferences, and published in peer-reviewed journals.Trial registration numberClinicalTrials.gov (NCT02213380); pre-results.

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