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?

IntroductionInflammation, dehydration, hypotension and bleeding may all contribute to the development of acute kidney injury (AKI). Accelerated surgery after a hip fracture can decrease the exposure time to such contributors and may reduce the risk of AKI.Methods and analysisHip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) is a multicentre, international, parallel-group randomised controlled trial (RCT). Patients who suffer a hip fracture are randomly allocated to either accelerated medical assessment and surgical repair with a goal of surgery within 6 hours of diagnosis or standard care where a repair typically occurs 24 to 48 hours after diagnosis. The primary outcome of this substudy is the development of AKI within 7 days of randomisation. We anticipate at least 1998 patients will participate in this substudy.Ethics and disseminationWe obtained ethics approval for additional serum creatinine recordings in consecutive patients enrolled at 70 participating centres. All patients provide consent before randomisation. We anticipate reporting substudy results by 2021.Trial registration numberNCT02027896; Pre-results.

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Accelerated surgery versus standard care in hip fracture (HIP ATTACK): an international, randomised, controlled trial

The Lancet ◽

10.1016/s0140-6736(20)30058-1 ◽

2020 ◽

Vol 395 (10225) ◽

pp. 698-708 ◽

Cited By ~ 34

Author(s):

Flavia K Borges ◽

Mohit Bhandari ◽

Ernesto Guerra-Farfan ◽

Ameen Patel ◽

Alben Sigamani ◽

...

Keyword(s):

Hip Fracture ◽

Randomised Controlled Trial ◽

Standard Care ◽

Controlled Trial ◽

Randomised Controlled

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Rationale and design of the HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) Trial: a protocol for an international randomised controlled trial evaluating early surgery for hip fracture patients

BMJ Open ◽

10.1136/bmjopen-2018-028537 ◽

2019 ◽

Vol 9 (4) ◽

pp. e028537 ◽

Cited By ~ 4

Author(s):

Flavia K Borges ◽

Mohit Bhandari ◽

Ameen Patel ◽

Victoria Avram ◽

Ernesto Guerra-Farfán ◽

...

Keyword(s):

Surgical Treatment ◽

Hip Fracture ◽

Randomised Controlled Trial ◽

Standard Care ◽

Perioperative Complications ◽

Public Awareness ◽

Controlled Trial ◽

Early Surgery ◽

All Cause Mortality ◽

Randomised Controlled

IntroductionAnnually, millions of adults suffer hip fractures. The mortality rate post a hip fracture is 7%–10% at 30 days and 10%–20% at 90 days. Observational data suggest that early surgery can improve these outcomes in hip fracture patients. We designed a clinical trial—HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) to determine the effect of accelerated surgery compared with standard care on the 90-day risk of all-cause mortality and major perioperative complications.Methods and analysisHIP ATTACK is a multicentre, international, parallel group randomised controlled trial (RCT) that will include patients ≥45 years of age and diagnosed with a hip fracture from a low-energy mechanism requiring surgery. Patients are randomised to accelerated medical assessment and surgical repair (goal within 6 h) or standard care. The co-primary outcomes are (1) all-cause mortality and (2) a composite of major perioperative complications (ie, mortality and non-fatal myocardial infarction, pulmonary embolism, pneumonia, sepsis, stroke, and life-threatening and major bleeding) at 90 days after randomisation. All patients will be followed up for a period of 1 year. We will enrol 3000 patients.Ethics and disseminationAll centres had ethics approval before randomising patients. Written informed consent is required for all patients before randomisation. HIP ATTACK is the first large international trial designed to examine whether accelerated surgery can improve outcomes in patients with a hip fracture. The dissemination plan includes publishing the results in a policy-influencing journal, conference presentations, engagement of influential medical organisations, and providing public awareness through multimedia resources.Trial registration numberNCT02027896; Pre-results.

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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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Improve hip fracture outcome in the elderly patient (iHOPE): a study protocol for a pragmatic, multicentre randomised controlled trial to test the efficacy of spinal versus general anaesthesia

BMJ Open ◽

10.1136/bmjopen-2018-023609 ◽

2018 ◽

Vol 8 (10) ◽

pp. e023609 ◽

Cited By ~ 19

Author(s):

Ana Kowark ◽

Christian Adam ◽

Jörg Ahrens ◽

Malek Bajbouj ◽

Cornelius Bollheimer ◽

...

Keyword(s):

Hip Fracture ◽

General Anaesthesia ◽

Controlled Trial ◽

Length Of Hospital Stay ◽

Pulmonary Complications ◽

Open Label ◽

Hip Fracture Surgery ◽

All Cause Mortality ◽

Randomised Controlled ◽

Fracture Surgery

IntroductionHip fracture surgery is associated with high in-hospital and 30-day mortality rates and serious adverse patient outcomes. Evidence from randomised controlled trials regarding effectiveness of spinal versus general anaesthesia on patient-centred outcomes after hip fracture surgery is sparse.Methods and analysisThe iHOPE study is a pragmatic national, multicentre, randomised controlled, open-label clinical trial with a two-arm parallel group design. In total, 1032 patients with hip fracture (>65 years) will be randomised in an intended 1:1 allocation ratio to receive spinal anaesthesia (n=516) or general anaesthesia (n=516). Outcome assessment will occur in a blinded manner after hospital discharge and inhospital. The primary endpoint will be assessed by telephone interview and comprises the time to the first occurring event of the binary composite outcome of all-cause mortality or new-onset serious cardiac and pulmonary complications within 30 postoperative days. In-hospital secondary endpoints, assessed via in-person interviews and medical record review, include mortality, perioperative adverse events, delirium, satisfaction, walking independently, length of hospital stay and discharge destination. Telephone interviews will be performed for long-term endpoints (all-cause mortality, independence in walking, chronic pain, ability to return home cognitive function and overall health and disability) at postoperative day 30±3, 180±45 and 365±60.Ethics and disseminationiHOPE has been approved by the leading Ethics Committee of the Medical Faculty of the RWTH Aachen University on 14 March 2018 (EK 022/18). Approval from all other involved local Ethical Committees was subsequently requested and obtained. Study started in April 2018 with a total recruitment period of 24 months. iHOPE will be disseminated via presentations at national and international scientific meetings or conferences and publication in peer-reviewed international scientific journals.Trial registration numberDRKS00013644; Pre-results

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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

BMJ Open ◽

10.1136/bmjopen-2020-047382 ◽

2021 ◽

Vol 11 (12) ◽

pp. e047382

Author(s):

Jiacheng Liu ◽

Yiting Lei ◽

Junyi Liao ◽

Xi Liang ◽

Ning Hu ◽

...

Keyword(s):

Hip Fracture ◽

Randomised Controlled Trial ◽

Blood Loss ◽

Tranexamic Acid ◽

Controlled Trial ◽

Inflammatory Factors ◽

Controlled Clinical Trial ◽

Hip Fracture Surgery ◽

Hidden Blood Loss ◽

Randomised Controlled

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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