Trial document




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  DRKS00013644

Trial Description

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Title

Improve Hip Fracture Outcome In The Elderly Patient (iHOPE): a multicentre randomized controlled trial to test the efficacy of spinal versus general anaesthesia

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Trial Acronym

iHOPE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

iHOPE aims to evaluate the effect of two different standard anaesthesia care approaches (spinal and general anaesthesia) for hip fracture surgery on the outcomes of patients up to 365 ± 60 days. iHOPE aims to optimize the efficacy, clinical and cost effectiveness of anaesthesia care for hip fracture patients.

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Brief Summary in Scientific Language

This is a pragmatic, confirmatory, comparative, national, multicentre, actively controlled, randomized, open-label, prospective, parallel-group study that will enroll 1032 patients with hip fracture (femoral neck or intertrochanteric fracture) needing surgical treatment.
The aim of this study is to optimize patient care. For this purpose, spinal and general anesthesia with regard to recovery and mental (postoperative delirium, depression and satisfaction with treatment) and physical (mortality, regaining running and self-reliance, severe new comorbidities) health status of elderly patients after their hip replacement surgery will be compared.

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Organizational Data

  •   DRKS00013644
  •   2018/04/10
  •   [---]*
  •   yes
  •   Approved
  •   EK 022/18, Ethik-Kommission an der Medizinischen Fakultät der RWTH Aachen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   S70-S79 -  Injuries to the hip and thigh
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Interventions/Observational Groups

  •   Hip fracture surgery with standard care general anaesthesia
  •   Hip fracture surgery with standard care spinal anaesthesia
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

To test Efficacy of spinal versus general anaesthesia on allcause mortality and new-onset (i.e. not pre-existing at time of surgery) serious cardiac and pulmonary complications up to 30-days after hip fracture surgery.

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Secondary Outcome

1) Difference in the proportion of patients alive and delirium free in the first 4 days after hip fracture surgery. Delirium will be assessed via in-person interview by the validated, high sensitive and specific assessment tool 3D-Confusion Assessment Method (3D-CAM). It will be applied at baseline and daily on the first 4 postoperative days.
2) Difference in the proportion of patients with postoperative pain; and in the characteristics and duration of postoperative pain between the two treatment arms. Pain will be assessed via numeric rating scale (NRS 0-10) and questions derived from the Brief Pain Inventory and the German pain questionnaire. Assessment will be performed via in-person interview at baseline and each postoperative visit during hospital stay. After discharge, it will be performed via telephone interview at each follow-up visit.
3) Difference in the satisfaction with care between the two treatment arms, assessed at day 4 or the day of discharge (whichever occurs first). The Bauer Patient Satisfaction Questionnaire will be used via in-person interview on postoperative day 4 or at discharge (whichever occurs first), to assess the patients´ satisfaction.
4) Difference in the number of in-hospital events, which include (but not limited to): Planned and unplanned admission to critical care; length of hospital and intensive care stay; length of hospital stay longer than expected; independence in walking and the need for assistive devices for walking at hospital discharge; postoperative hospital discharge destination; in hospital all-cause mortality and severe new-onset complications as those used by the NSQIP. These events will be assessed on the discharge day from hospital or at least at postoperative day 30 via in-person interview and medical record review.
5) Difference in the proportion or means of long-term outcomes at day 30 ± 3, day 180 ± 45 and day 365 ± 60 after randomization will include: All cause-mortality, independence in walking and need for assistive devices for walking; chronic pain; ability to return home; cognitive function via Short blessed test (SBT); and overall health and disability via World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). Except of the cognitive function and chronic pain, which could only be assessed via telephone interview of the patient, all other data could also be assessed via telephone interview of the proxy.
6) Difference in the proportion of patients with perioperative serious adverse events like intraoperative cardiac arrest; malignant hyperthermia; intraoperative anaphylaxis; intraoperative aspiration; total spinal anaesthesia; epidural hematoma; paralysis of the lower extremities lasting greater than 24 hours following spinal anaesthesia; fall within 12 hours of anaesthesia care. These data will be assessed during the surgery and the postoperative in-hospital visits via in-person interview and medical record review.
7) Sensitivity and subgroup analyses of the primary outcome will consider the baseline proportion of patients with depression and frailty. Depression will be assessed via the 15-items short version of the Geriatric Depression Scale (GDS) at baseline via in-person interview. Frailty assessment will be performed according to phenotype-model of Fried at baseline via in-person interview. Four of originally five Fried-criteria will be assessed: fatigue, maximal grip strength assessment of the dominant hand, physical activity (employing the Minnesota Leisure Time Activities Questionnaire) and weight loss in the past year. Gait velocity as the fifth Fried criterion will be omitted in this study for obvious reasons.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2018/04/25
  •   1032
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   65   Years
  •   no maximum age
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Additional Inclusion Criteria

Age ≥ 65 years; signed informed consent; suffers from intra-/extracapsular hip fracture (e.g. femoral neck fracture, subtrochanteric or intertrochanteric fracture), planned surgical treatment via hemiarthroplasty, total hip arthroplasty or appropriate osteosynthetic procedure

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Exclusion Criteria

People who are institutionalized by court or administrative order;
planned concurrent surgery not amenable to spinal anaesthesia;
absolute contraindications to spinal anaesthesia; periprosthetic
fracture; prior participation in the iHOPE study; as determined by the
attending surgeon, the attending anaesthesiologist, or the site
principle investigator or their designate, that the patient or the
attending team would not be suitable for a randomization procedure

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Addresses

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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.