Evaluation of Relationship Between Preoperative Fibrinogen/Albumin Ratio and Morbidity After Hip Fracture Operations

NCT05272072 | Completed

• 1 other identifier: 2021/1968
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Due to the aging of populations, hip fracture operations are increasing from year to year. This operations have many complications also high morbidity and the mortality. Population of this study is oldest old age patients who will have an operation because of hip fracture. The primary outcome of this study is evaluation of relationship between preoperative fibrinogen/albumin ratio and the morbidity after hip fracture operations. The secondary outcomes of this study is evaluation of relationships between fibrinogen/albumin ratio and mortality, length of stay in ICU, length of stay in hospital, postoperative complications, blood product consumption. The study will be completed after the records of preoperative, intraoperative data and the data of the first 30 days postoperatively in this population.

Conditions

Hip Fractures; Albumin; Fibrinogen; Scoring Systems; Preoperative Risk Prediction; Elderly

Outcome Measures

Primary Outcomes (1)

• Morbidity

  Age Adjusted Charlson Comorbidity Index will be calculated for morbidity estimation. This score predicts the ten-year mortality for a patient who may have a range of comorbid conditions. The minimum score is 4 for oldest old patients. The maximum score is 34. Higher scores mean a worse outcome.

  Preoperative (before induction of anesthesia)

Secondary Outcomes (7)

• Nottingham Hip Fracture Score

  Preoperative (before induction of anesthesia)

• Clinical Frailty Scale Score

  Preoperative (before induction of anesthesia)

• Mortality

  Up to 30 days

• Length of stay in ICU

  Up to 30 days

• Length of stay in hospital

  Up to 30 days

Eligibility Criteria

• Age: 85 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients over 85 years of age who will undergo hip fracture surgery, whose preoperative albumin/fibrinogen ratio is checked

You may qualify if:

• ≥85 years old patients
• Primary operation
• Undergoing hip fracture surgery
• Receiving consent from patients or guardians that they accept regional anesthesia
• Not having active infection
• American Society of Anesthesiologists (ASA) 1-4
• BMI\< 40 kg/m²

You may not qualify if:

• Refusal regional anesthesia
• Infection on regional anesthesia application area
• Infection in the central nervous system
• Coagulopathy
• Known allergy against local anesthetics
• Severe hepatic insufficiency
• Haematologic disease
• Rheumatological disease
• Autoimmune disease

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Emine Dizem Sunal, MD

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, M.D.

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: March 9, 2022
• Study Start: March 30, 2022
• Primary Completion: February 21, 2023
• Study Completion: March 1, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-03

Locations

TU (1)