ArthropathyPABMOSNCT05319223
Patient Blood Management in Orthopedic Surgical Patients in Turkey
An observational study of Arthropathy, run by Prof. Serdar Gunaydin at 1 site in Turkey (Türkiye).
Trial summary
Transfusion practice for surgical patients has changed from replacing surgically lost blood with allogeneic blood transfusions to implementing strategies that reduce transfusion requirements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthropathy
- What is being tested?
- patient blood management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 369 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 1 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing arthroplasty with anemia
Who may be able to join
- In order to be eligible to participate in this trial, an individual must meet all of the following criteria:
- Signed patient informed consent
- Male or female patient at least 18 years old
- Patients scheduled for an elective major orthopaedic surgery (hip arthroplasty, knee arthroplasty, primary and revision operations)
- Patients with confirmed iron deficiency anemia (IDA), defined as Hb 100-130 g/L, and serum ferritin < 100 ng/ml or TSAT < 20%.
- Patients with iron deficiency anemia will be taken into surgery at least 3 weeks after the treatment.
Who cannot join
- Patients that undergo emergency surgical procedure and trauma cases are excluded from the study.
- Patients with non-iron deficiency anaemia (thalassemia, sickle cell anaemia and etc.)
- Patients with renal anaemia (Hb < 130 g/L and CCL < 50 mL/min, irrespective of iron parameters) or any diagnosis that require EPO will be excluded
- Patients with known anaphylactic/hypersensitivity reactions to parenteral iron products.
- Patients with iron overload or disturbances in utilization of iron (e.g. haemochromatosis, hemosiderosis)
- Patients with ≥3 times increase in aspartate aminotransferase or alanine aminotransferase as per reference range.
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- Patients with excessive blood loss requiring massive transfusion (≥ 10 more red blood cell units)
- Patients with known myelodysplastic syndromes.
- Patients with chronic kidney disease with an estimated GFR < 30 ml/min or with end-stage renal disease requiring scheduled dialysis.
- Patients with known urinary tract infections with urea-splitting bacteria
- Any patient judged to lack the ability to give informed consent or perform the trial assessments (e.g. due to dementia)
- Women who are pregnant or breast feeding
- Intention to become pregnant during the course of the study,
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases (Female participants who are surgically sterilized / hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential),
- Known or suspected non-compliance, drug or alcohol abuse,
- Participation in another study with investigational drug within the 30 days preceding and during the present study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara University
Ankara
Cigdem YILDIRIM GUCLU
About this study
Transfusion practice for surgical patients has changed from replacing surgically lost blood with allogeneic blood transfusions to implementing strategies that reduce transfusion requirements. Patient Blood Management (PBM), which is "the timely application of evidence-based medical and surgical concepts designed to maintain haemoglobin concentration, optimize hemostasis and minimize blood loss in an effort to improve patient outcome. There is mounting evidence that multimodal patient blood management (PBM) programmes can be effective at improving postoperative outcomes and reducing perioperative blood transfusions and costs The Turkish Society of Anaesthesiologists PBM Task Force has been working on this subject and studied transfusion practice throughout all through the peri-operative periods. Unfortunately we documented a high transfusion rate in major surgical patients in Turkey. One of the surgeries, that has high transfusion rate, was orthopaedic surgery. According to our recent data we planned to implement PBM in major orthopaedic surgical patients and evaluate the effects PBM in transfusion rate and patient outcomes. While some elements of PBM have a strong evidence base in hip or knee replacement, such as the use of tranexamic acid (TXA) the evidence for preoperative anaemia optimisation with iron is less robust. Implementing PBM all through the operative period gains more importance.
Read the detailed description
Active PBM Implementation: Patients undergoing hip or knee arthroplasty will be treated as follows: PBM will be performed as shown in the graph below "PBM Implementation Group".
Active PBM group will be treated for preoperative anemia at least 3 weeks prior to the surgical intervention as per the "Anemia Algorithm" below Other pillars of PBM will be also performed to the treatment group as per the visual graph below. The parameters included in the PBM pillars will be recorded including preoperative anemia parameters. Postoperative variables and parameters related to complications will be recorded.
For the control group (Non-PBM group), the data of the patients, will be prospectively included.
The 1:1 ratio of the control and active groups will be done.
- Conditions
- Arthropathy
- Being tested
- patient blood management
- Keywords
- Arthroplasty, patient blood management, anemia, İron deficiency
- Medical subject headings
- Joint Diseases, Anemia, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient blood managementBehavioural
three pillars of patient blood management will be applied
| Study group | Role | What they receive |
|---|---|---|
| Patient management group | patient blood management group Receives: Behavioral: patient blood management | |
| Control | control |
What is being measured
The primary outcome is the main question the study is designed to answer.
red cell transfusion
change in red blood cell transfusion rate
Measured: 3 days
Secondary outcomes (1)
cost
change in total hospital cost
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 Feb 2022
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthropathyStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 369 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Serdar Gunaydin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Serdar Gunaydin, ERAS Turkey Association
- Investigators
- Cigdem YILDIRIM GUCLU, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319223
- Sponsor's protocol ID
- 110-627-21
- Acronym
- PABMOS
- Status last verified
- Mar 2022
- First submitted
- 28 Feb 2022
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Blood Management in Orthopedic Surgical Patients in Turkey
- ClinicalTrials.gov ID
- NCT05319223
- Acronym / sponsor ID
- PABMOS / 110-627-21
- Conditions
- Arthropathy
- Keywords
- Arthroplasty, patient blood management, anemia, İron deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 369 participants (estimated)
- Lead sponsor
- Prof. Serdar GunaydinUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 8 Apr 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.
Transfusion practice for surgical patients has changed from replacing surgically lost blood with allogeneic blood transfusions to implementing strategies that reduce transfusion requirements. Patient Blood Management (PBM), which is "the timely application of evidence-based medical and surgical concepts designed to maintain haemoglobin concentration, optimize hemostasis and minimize blood loss in an effort to improve patient outcome. There is mounting evidence that multimodal patient blood management (PBM) programmes can be effective at improving postoperative outcomes and reducing perioperative blood transfusions and costs The Turkish Society of Anaesthesiologists PBM Task Force has been working on this subject and studied transfusion practice throughout all through the peri-operative periods. Unfortunately we documented a high transfusion rate in major surgical patients in Turkey. One of the surgeries, that has high transfusion rate, was orthopaedic surgery. According to our recent data we planned to implement PBM in major orthopaedic surgical patients and evaluate the effects PBM in transfusion rate and patient outcomes. While some elements of PBM have a strong evidence base in hip or knee replacement, such as the use of tranexamic acid (TXA) the evidence for preoperative anaemia optimisation with iron is less robust. Implementing PBM all through the operative period gains more importance.
Detailed description
Active PBM Implementation: Patients undergoing hip or knee arthroplasty will be treated as follows: PBM will be performed as shown in the graph below "PBM Implementation Group".
Active PBM group will be treated for preoperative anemia at least 3 weeks prior to the surgical intervention as per the "Anemia Algorithm" below Other pillars of PBM will be also performed to the treatment group as per the visual graph below. The parameters included in the PBM pillars will be recorded including preoperative anemia parameters. Postoperative variables and parameters related to complications will be recorded.
For the control group (Non-PBM group), the data of the patients, will be prospectively included.
The 1:1 ratio of the control and active groups will be done.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient management group | – | Behavioral: patient blood managementpatient blood management group |
| Control | – | –control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing arthroplasty with anemia
Key inclusion criteria (6 listed)
- In order to be eligible to participate in this trial, an individual must meet all of the following criteria:
- Signed patient informed consent
- Male or female patient at least 18 years old
- Patients scheduled for an elective major orthopaedic surgery (hip arthroplasty, knee arthroplasty, primary and revision operations)
- Patients with confirmed iron deficiency anemia (IDA), defined as Hb 100-130 g/L, and serum ferritin < 100 ng/ml or TSAT < 20%.
Key exclusion criteria (16 listed)
- Patients that undergo emergency surgical procedure and trauma cases are excluded from the study.
- Patients with non-iron deficiency anaemia (thalassemia, sickle cell anaemia and etc.)
- Patients with renal anaemia (Hb < 130 g/L and CCL < 50 mL/min, irrespective of iron parameters) or any diagnosis that require EPO will be excluded
- Patients with known anaphylactic/hypersensitivity reactions to parenteral iron products.
- Patients with iron overload or disturbances in utilization of iron (e.g. haemochromatosis, hemosiderosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient blood managementthree pillars of patient blood management will be applied | Behavioural | Patient management group |
Primary outcome
red cell transfusion
Time frame: 3 days
change in red blood cell transfusion rate
1 secondary outcome
cost
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
Cigdem YILDIRIM GUCLU principal investigator
Ankara 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 Arthropathy, run by Prof. Serdar Gunaydin 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 6 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 8 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cigdem YILDIRIM GUCLU (+905324576648, drcigdemyldrm@yahoo.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
red cell transfusion (time frame: 3 days). 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 8 Apr 2022.