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Hip FracturesNCT05272072

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

An observational study of Hip Fractures and Albumin, run by Istanbul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 85 years and older
Conditions the study is for
Hip Fractures, Albumin, Fibrinogen
How many people
108 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Mar 2022to 1 Mar 2023
How long will I take part?
1 Month
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 85 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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

Who may be able to join

  • ≥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

Who cannot join

  • Refusal regional anesthesia
  • Infection on regional anesthesia application area
  • Infection in the central nervous system
  • Coagulopathy
  • Known allergy against local anesthetics
  • Severe hepatic insufficiency
Show all 9Show fewer
  • Haematologic disease
  • Rheumatological disease
  • Autoimmune disease

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul University

    Istanbul, Fatih, 34093

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Relationship Between Preoperative Fibrinogen/Albumin Ratio and Morbidity After Hip Fracture Operations in Oldest Old Patients: A Prospective Observational Study

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.

Read the detailed description

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. Elderly people are divided into 3 groups according to their age. Elderly people whose aged over 85 years as oldest-old. Population of this study is oldest old patients who will have an operation because of hip fracture.

The research is as a single-center, prospective observational study. The primary outcome of this study is evaluation of relationship between preoperative fibrinogen/albumin ratio and the morbidity after hip fracture operations. Age-Adjusted Charlson Comorbidity Index, Nottingham Hip Fracture Score and Clinical Frailty Scale Score will be calculated at the preoperative visit for each patient before operation. Investigators planned to use these three scores to determine morbidity.

Age-Adjusted Charlson Comorbidity Index AACCI): Age-modified version of the Charlson Comorbidity Index. Charlson Comorbidity Index predicts the ten-year mortality for a patient who may have a range of comorbid conditions for example diabetes, myocardial infarction, dementia, liver disease, lymphoma. Each comorbid condition has a separate point. 71 years old and older patients have +4 points for scoring of Age-Adjusted Charlson Comorbidity Index. The sum of the scores gives the total score. The minimum score is 4 for oldest old patients. Higher scores mean a worse outcome.

Nottingham Hip Fracture Score (NHFS) is a scoring system that reliably predicts 30 day mortality for patients after hip fracture. Development and validation of a preoperative scoring system to predict 30 day mortality in patients undergoing hip fracture surgery. To calculate the NHFS, it is necessary to calculate the abbreviated mental test score of 10 points in total. The minimum score is 3 for oldest old patients. The maximum score is 10. Higher scores mean a worse outcome.

The Clinical Frailty Scale (CFS) is a judgement-based frailty tool that evaluates specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill). Higher scores mean a worse outcome.

The secondary outcomes of this study is evaluation of relationships between fibrinogen/albumin ratio and Nottingham Hip Fracture Score, Clinical Frailty Scale Score, mortality, length of stay in ICU, length of stay in hospital, blood product consumption, postoperative complications. Postoperative complications are divided into pulmonary, cardiovascular, hepatic, renal complications, bleeding, electrolyte imbalance, wound site infections, delirium and other. Postoperative pulmonary complications (PPC) encompass almost any complication affecting the respiratory system after anaesthesia and surgery. PPCs are bronchospasm, aspiration pneumonia, atelectasis, pneumonia, pleural effusion, pneumothorax, pulmonary embolism, respiratory failure, acute respiratory distress syndrome, tracheobronchitis etc. Postoperative cardiac complications are resistant hypotension- hypertension, new onset of dysrhythmias like atrial fibrillation, acute coronary syndromes, cardiac failure, cardiogenic shock. Investigators will follow up postoperative hemogram and record amount of blood transfused to investigate bleeding. Investigators will follow up serum creatinin and urea level, use Kidney Disease Improving Global Outcomes (KDIGO) criteria for acute renal failure and note necessity of hemodialysis or hemodiafiltration.

Before the study, it was determined that at least 108 patients should be collected in the power analysis performed with the help of similar literature data. After collecting the demographic and peroperative data up to postoperative 30 days of the patients, the data will be transferred to the statistical program called SPSS and statistical analysis will be made. The investigators study does not contain any modifications other than the investigators daily routine practices.

Medical subject headings
Hip Fractures

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Preoperative (before induction of anesthesia)

Secondary outcomes (7)
  1. Nottingham Hip Fracture Score

    Development and validation of Nottingham Hip Fracture Score to predict 30 day mortality in patients undergoing hip fracture surgery. The minimum score is 3 for oldest old patients.The maximum score is 10. Higher scores mean a worse outcome.

    Measured: Preoperative (before induction of anesthesia)

  2. Clinical Frailty Scale Score

    A judgement-based frailty tool that evaluates specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill). Higher scores mean a worse outcome.

    Measured: Preoperative (before induction of anesthesia)

  3. Mortality

    Death rate of the patients

    Measured: Up to 30 days

  4. Length of stay in ICU

    Duration of stay (days) in intensive care unit because of hip fracture

    Measured: Up to 30 days

  5. Length of stay in hospital

    Duration of stay (days) in hospital because of hip fracture from admission to discharge.

    Measured: Up to 30 days

  6. Postoperative complications

    Addition of a new disease or problem after hip fracture operation.

    Measured: Up to discharge (up to 30 days)

  7. Amount of intraoperative and postoperative blood product replacement

    Amount of blood product replacement in operation room and after operation up to discharge (up to 30 days)

    Measured: Up to discharge (up to 30 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2022
  2. Study start30 Mar 2022
  3. Primary completion21 Feb 2023
  4. Study completion1 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
108 participants (actual)
Target duration
1 Month
IDs, dates and publications
ClinicalTrials.gov ID
NCT05272072
Sponsor's protocol ID
2021/1968
Status last verified
Mar 2023
First submitted
11 Feb 2022
Last updated
2 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hip Fractures and Albumin, run by Istanbul University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morbidity (time frame: Preoperative (before induction of anesthesia)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.

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