HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 Trial

Browse trials for

• Hip Fractures 842

Hip Fractures

842 studies on the registry are indexed under Hip Fractures; 165 are open to participants now.

This study's planned enrollment of 1,100 is above the median of 86 across 533 interventional studies indexed under Hip Fractures.

Lead sponsor

Population Health Research Institute is the lead sponsor of 115 studies on the registry; 26 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Study arms

• Experimental
  Accelerated medical clearance and surgery

  Accelerated medical clearance and targeted arrival to the operating room within 6 hours of eligibility criteria met.

  Other: Accelerated medical clearance and surgery

• No intervention
  Standard surgical care

  Hip fracture repair and surgical care according to treating institution guidelines.

Interventions

• OtherAccelerated medical clearance and surgery

  Rapid medical clearance with targeted arrival to the operating room within 6 hours of eligibility criteria criteria met.

Primary outcomes

1. All cause mortality

   Death due to all causes

   Time frame: Within 90 days post randomization

Secondary outcomes

1. Ability to independently walk 3 meters

   Ability to independently walk 3 meters (10 feet) or across a room without human assistance. Patients who require a cane or walker, but not human assistance, will be classified as able to walk independently. Patients who require assistance to get out of a chair, but can walk independently once they get up, will be classified as able to walk independently.

   Time frame: Within 90 days post randomization

2. Composite of major complications

   Composite includes vascular and nonvascular mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke.

   Time frame: Within 90 days post randomization

3. Vascular mortality

   Any death with a vascular cause and includes those deaths following a myocardial infarction, sudden cardiac arrest, stroke, cardiac revascularization procedure (i.e., percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\] surgery), heart failure, pulmonary embolus, cardiovascular hemorrhage, or deaths due to an unknown cause

   Time frame: Within 90 days post randomization

4. Nonvascular mortality

   Any death due to a clearly documented non-vascular cause.

   Time frame: Within 90 days post randomization

5. Myocardial Infarction

   Diagnosis of MI according to 4th universal definition of myocardial infarction

   Time frame: Within 90 days post randomization

6. Acute Congestive Heart Failure

   at least one clinical sign(s) or symptom(s) (e.g elevated jugular venous pressure, respiratory rales/crackles, crepitations, hypoxia, tachypnea or presence of S3) with at least one of the following: 1. radiographic findings (i.e., vascular redistribution, interstitial pulmonary edema, or frank alveolar pulmonary edema) or point of care ultrasound findings (i.e., bilateral B-lines, bilateral pleural effusion, elevated jugular venous pressure, dilated inferior vena cava with respiratory variation less than 50%) OR 2. heart failure treatment implemented with diuretics with documented clinical improvement.

   Time frame: Within 90 days post randomization

7. Stroke

   Either - 1. a new focal neurological deficit thought to be vascular in origin with signs or symptoms lasting more than 24 hours or leading to death; or 2. a new focal neurological deficit thought to be vascular in origin with signs or symptoms lasting less 24 hours with a positive neuroimaging consistent with a stroke

   Time frame: Within 90 days post randomization

8. Time from randomization to hospital discharge

   Length of hospital stay from randomization to hospital discharge

   Time frame: Within 90 days post randomization

9. Delirium

   1. Patient meets the criteria for delirium on any in-person 3D-CAM or CAM administered; OR 2. Positive history of delirium in the 7 days after randomization based on the review of hospital health records.

   Time frame: Within 7 days and 90 days post randomization

10. Moderate to severe pain

    Moderate to severe pain is defined as any pain score ≥3 on 10 points scale.

    Time frame: Within 7 days and 90 days post randomization

Other outcomes

1. New clinically important atrial fibrillation or flutter

   Documentation of atrial fibrillation or atrial flutter of any duration on an ECG, telemetry tracing, or rhythm strip and results in angina, congestive heart failure, symptomatic hypotension, or is followed by initiation or a dose increase of a rate controlling drug, antiarrhythmic drug, or electrical cardioversion.

   Time frame: Within 90 days post randomization

2. Cardiac revascularization procedure

   Revascularization procedures including coronary artery bypass graft or percutaneous coronary intervention surgery.

   Time frame: Within 90 days post randomization

3. Venous thromboembolism

   Venous pulmonary embolism or deep venous thrombosis

   Time frame: Within 90 days post randomization

4. Pulmonary embolism

   The diagnosis of PE requires any one of the following: 1. A high probability ventilation/perfusion lung scan, 2. An intraluminal filling defect of a segmental or larger artery on a helical CT scan, 3. An intraluminal filling defect on pulmonary angiography, or 4. A positive diagnostic test for DVT (e.g., positive compression ultrasound) and one of the following: A. Non-diagnostic (i.e., low or intermediate probability) ventilation/perfusion lung scan B. Non-diagnostic (i.e., subsegmental defects or technically inadequate study) helical CT scan.

   Time frame: Within 90 days post randomization

5. Proximal deep venous thrombosis

   The diagnosis of proximal DVT requires: 1. Thrombosis involving the popliteal vein or more proximal veins for leg DVT and axillary or more proximal veins for arm DVT, AND 2. Evidence of vein thrombosis by any one of the following: 1\. A persistent intraluminal filling defect on contrast venography, 2. Noncompressibility of one or more venous segments on B mode compression ultrasonography, or 3. A clearly defined intraluminal filling defect on contrast enhanced computed tomography.

   Time frame: Within 90 days post randomization

6. Infection

   Pathologic process caused by the invasion of normally sterile tissue or fluid or body cavity by pathogenic or potentially pathogenic organisms.

   Time frame: Within 90 days post randomization

7. Sepsis

   Based on the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) criteria,20 sepsis will require a quick Sequential Organ Failure Assessment (qSOFA) Score ≥2 points or patients requiring vasopressors/inotropes due to infection. The qSOFA includes the following items and scoring system: 1. Altered mental status (1 point), 2. Systolic blood pressure (SBP)of 100 mm Hg or less (1 point), and 3. Respiratory rate (RR) of 22 breaths/min or more (1 point).

   Time frame: Within 90 days post randomization

8. Pneumonia

   Acute infection of the pulmonary parenchyma that is associated with at least one sign or symptom of lower respiratory acute infection (e.g., cough, pleuritic chest pain) or acute systemic illness (e.g., fever, chills, confusion, hypoxemia); accompanied by the presence of an acute infiltrate/consolidation on a chest radiograph or auscultatory findings consistent with pneumonia (such as crackles and/or localized rales) for which there is no other explanation.

   Time frame: Within 90 days post randomization

9. Bleeding

   Life threatening, major or critical organ bleeding

   Time frame: Within 90 days post randomization

10. Hip reoperation

    Any second surgical procedure undertaken on the fractured hip being followed in the study, for any reason (e.g. infection, implant failure, periprosthetic fracture, wound dehiscence, etc.), after it has been initially repaired and the patient has left the operating room.

    Time frame: Within 90 days post randomization

11. Prosthetic hip dislocation

    Any acute dislocation of a prosthetic femoral head from within its intended concentric location within the acetabulum. The acetabulum may or may not be resurfaced/replaced.

    Time frame: Within 90 days post randomization

12. Implant failure

    Any mechanical issue related to the integrity of any component of the hip implant which requires a surgical procedure to correct. This includes: loss of implant fixation to bone (either with or without associated periprosthetic fracture); or broken, disassociated, or dislocated implant components.

    Time frame: Within 90 days post randomization

13. Peri-prosthetic fracture

    Fracture through any part of either the femur and/or acetabulum to which a hip implant used for hip repair/reconstruction was fixed.

    Time frame: Within 90 days post randomization

14. Acute kidney injury

    An increase in the serum creatinine concentration from the pre-randomization value of ≥26.5 μmol/L (≥0.3 mg/dL) within 48 hours after randomization, or an increase of ≥50% within 7 days after randomization.

    Time frame: Within 90 days post randomization

15. Acute renal failure resulting in dialysis

    New requirement for dialysis (i.e., use of hemodialysis machine or peritoneal dialysis apparatus in patients without a requirement for dialysis prior to randomization).

    Time frame: Within 90 days post randomization

16. Hospital re-admission

    Hospital re-admission following discharge from index hospitalization

    Time frame: Within 90 days post randomization

17. Length of critical care stay

    Length of critical care stay

    Time frame: Within 90 days post randomization

18. Length of rehabilitation stay

    Length of rehabilitation stay

    Time frame: Within 90 days post randomization

19. Days alive at home

    Days alive at home are the number of days patients spend at their usual residence without, during that day, being admitted to a hospital or visiting an emergency department or urgent-care centre. Patients lose days alive at home if 1. patients go to an emergency department or urgent-care centre; 2. they become inpatients at a hospital or rehabilitation or convalescence-care facility; or 3. they die.

    Time frame: Within 90 days post randomization

Individual participant data

Plan to share: No — The Population Health Research Institute (PHRI) is the sponsor of this trial. The PHRI believes the dissemination of clinical research results is vital and sharing of data is important. PHRI prioritizes access to data analyses to researchers who have worked on the trial for a significant duration, have played substantial roles, and have participated in raising the funds to conduct the trial. PHRI balances the length of the research study, and the intellectual and financial investments that made it possible with the need to allow wider access to the data collected. Data will be disclosed only upon request and approval of the proposed use of the data by a Review Committee.