Hip fracture MedDRA version: 18.0 Level: PT Classification code 10020100 Term: Hip fracture System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Trade Name: HIERRO SACAROSA NORMON
Product Name: HIERRO SACAROSA NORMON
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Iron Sucrose
CAS Number: 8047-67-4
Other descriptive name: IRON
Sponsors
Rafael Bielza Galindo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients included in the study with hip fracture osteoporotic treated in our unit, with the following characteristics: • Age over 75 years • Having borrowed agreed to participate in the study by signing the corresponding Informed Consent Document. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: Exclusion criteria: • Hypersensitivity to oral or parenteral preparations of iron. • Asthma or other severe atopy. • Withdrawal of informed consent. • No indication of surgical fracture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the incidence of postoperative delirium and functional gain in terms of the change in the Barthel scale between admission and discharge in patients with hip fracture between treated and untreated patients with intravenous iron.;Secondary Objective: Secondary objectives: • Evaluate the effectiveness of the administration of intravenous iron in patients with hip fracture to reduce transfusion requirements, both in the percentage of transfused, and the number of packed red blood cells needed. • To evaluate the safety of administration of iron sucrose intravenously. • Compare the number of bacterial infections (urinary, respiratory and surgical) wound between treated and untreated patients with intravenous iron. • Predict whether the treated patients have shorter length of stay hospital that treated. • Estimate whether treatment decreases mortality and readmissions within 30 days of the study patients.;Primary end point(s): Main efficacy endpoints: • The change in the Barthel scale between admission and discharge (functional gain): • Percentage of patients with "delirium" at some point of stay after surgery. Description of variables : • Functional Gain: - Barthel index at DISCHARGE - INCOME Barthel index at - A top 5 point difference is considered significant. • Delirium : presence of delirium from the patient to the ward from the recovery room arrives until he leaves hospital . 1. Acute onset and fluctuating course Have you noticed an acute change in mental status of the patient? If the answer is No, not follow the questionnaire Two . Disturbance in attention Does the patient is easily distracted or have difficulty following a conversation? If the answer is No, not follow the questionnaire 3. Disorganized thinking Does the patient expresses ideas or incoherent conversations or confuse people ? 4. Altered level of consciousness Is altered level of consciousness of the patient ( vigilant , lethargic, stuporous ) ? For the diagnosis o | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: • Functional Efficiency defined as Barthel index at DISCHARGE-ADMISSION Barthel index at / LENGTH OF STAY postsurgical. • Change in functional scale (WALKING) Red Cross between admission and discharge. • Percentage of patients required transfusion (pre, intra, post) and number of concentrates at all times • Percentage of patients with bacterial infections (urinary, respiratory and surgical wound) during admission • Length of stay (preoperative and global) • Mortality during stay • Readmission within 30 days after discharge. Security Variables: • Blood transfusion • Side effects following administration of intravenous iron. Secondary efficacy endpoints : • Functional Efficiency defined as Barthel index at DSICHARGE-ADMISSION Barthel index at / LENGTH OF STAY postsurgical . • Change in functional scale ( WANDERING ) Red Cross between admission and discharge * • Percentage of patients required transfusion (pre , intra and postoperative ) and number of concentrates at all times • Percentage of patients with bacterial infections ( urinary, respiratory and surgical wound) during admission • Length of stay ( preoperative and global) • Mortality during stay • Readmission within 30 days after discharge. Security Variables : • Blood transfusion • Side effects following administration of intravenous iron . * Modified Barthel Index evaluates 11 items and each is scored as reflected in parentheses: 1. Washing: ( 0 , 1, 3 , 4, 5 ) 2. Swimming: ( 0 , 1, 3 , 4, 5 ) 3. Eat (0, 2 , 5, 8 , 10) 4. Using the toilet ( 0 , 2, 5 , 8, 10 ) 5. Climbing stairs (0, 2 , 5, 8 , 10) 6. Dressing ( 0 , 2, 5 , 8, 10 ) 7. Control stool ( 0 , 2, 5 , 8, 10 ) 8. Urine Control ( 0 , 2, 5 , 8, 10 ) 9. Scroll ( 0 , 3, 8 , 12, 15 ) 10. Wheelchair ( 0 , 1, 3 , 4, 5 ) 11. Chair bed ( 0, 3 , 8, 12, 15 ) Transfer (0, 3, 8, 12, 15) Functional Scale ** Red Cross : 0 . Was totally worth by itself. Walking normally. 1. Enough Perfo | — |
Countries
Spain
Contacts
Public ContactRafael Bielza Galindo
Servicio de Medicina Interna/Geratria- Hospital Infanta Sofía
Outcome results
None listed