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).
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.
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.
- Conditions
- Hip Fractures, Albumin, Fibrinogen, Scoring Systems, Preoperative Risk Prediction, Elderly
- Medical subject headings
- Hip Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
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)
Mortality
Death rate of the patients
Measured: Up to 30 days
Length of stay in ICU
Duration of stay (days) in intensive care unit because of hip fracture
Measured: Up to 30 days
Length of stay in hospital
Duration of stay (days) in hospital because of hip fracture from admission to discharge.
Measured: Up to 30 days
Postoperative complications
Addition of a new disease or problem after hip fracture operation.
Measured: Up to discharge (up to 30 days)
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.
- First posted9 Mar 2022
- Study start30 Mar 2022
- Primary completion21 Feb 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Canbolat, Istanbul University
- Investigators
- Emine Dizem Sunal, MD, Principal investigator, Istanbul University
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Relationship Between Preoperative Fibrinogen/Albumin Ratio and Morbidity After Hip Fracture Operations in Oldest Old Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05272072
- Acronym / sponsor ID
- 2021/1968
- Conditions
- Hip Fractures, Albumin, Fibrinogen, Scoring Systems, Preoperative Risk Prediction, Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 85 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients over 85 years of age who will undergo hip fracture surgery, whose preoperative albumin/fibrinogen ratio is checked
Key inclusion criteria (7 listed)
- ≥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
Key exclusion criteria (9 listed)
- Refusal regional anesthesia
- Infection on regional anesthesia application area
- Infection in the central nervous system
- Coagulopathy
- Known allergy against local anesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Morbidity
Time frame: Preoperative (before induction of anesthesia)
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.
7 secondary outcomes
Nottingham Hip Fracture Score
Time frame: Preoperative (before induction of anesthesia)
Clinical Frailty Scale Score
Time frame: Preoperative (before induction of anesthesia)
Mortality
Time frame: Up to 30 days
Length of stay in ICU
Time frame: Up to 30 days
Length of stay in hospital
Time frame: Up to 30 days
Postoperative complications
Time frame: Up to discharge (up to 30 days)
Amount of intraoperative and postoperative blood product replacement
Time frame: Up to discharge (up to 30 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emine Dizem Sunal, MD principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
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.