OsteoarthritisPhase 4NCT02544828
Intravenous Iron Sucrose in Arthroplasty
A Phase 4 study testing Iron Sucrose 200mg in people with Osteoarthritis, run by Konkuk University Medical Center.
Trial summary
The objective of the present study is to determine the impact of intraoperative IV-iron supplementation on postoperative oxygenation profile by comparing the postoperative PaO2/FiO2 ratio with or without IV-iron supplementation in old patients undergoing elective uni-limb arthroplasty surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Iron Sucrose 200mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Sep 2016
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with osteoarthritis in knee joint undergoing elective uni-limb total knee arthroplasty surgery
- Patients provided a written informed consent.
- Patients with s-ferritin < 300 mg/dl (male) or 200 mg/dl (female)
- Patients with preoperative serum hemoglobin concentration >13 g/dL (male) and >12 g/dL (female)
- Patients with PaO2/FiO2 ratio >150
Who cannot join
- Patients with history of anaphylaxis, iron overload, active infection.
- Patients with endocrine disease
- Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, anti-fibrinolytic agents or recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Does Intraoperative Intravenous Iron Sucrose Enhance Postoperative Oxygenation Profile in Total Arthroplasty Surgery?
The objective of the present study is to determine the impact of intraoperative IV-iron supplementation on postoperative oxygenation profile by comparing the postoperative PaO2/FiO2 ratio with or without IV-iron supplementation in old patients undergoing elective uni-limb arthroplasty surgery.
Read the detailed description
Participation and recruitment: Patients undergoing elective total knee arthroplasty due to osteroarthritis will be interviewed for participation and recruited after providing written informed consent.
Randomization and group allocation:
All recruited patients will be given patient identification number (PIN) for the present study of 01-76 according to their order of interview and recruitment.
Investigators will prepare 33 yellow and 33 green cards, which will be inserted in 76 thick-paper envelopes. Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 76 (Envelop number).
After printing the envelope number outside envelope, all sealed envelopes with cards will be conveyed to and kept in pharmacy department.
Preparation and Administration of study drug:
Pharmacist will open the envelope with the number same to PIN and check the color of the card inside at study on operation day.
According to the color of the card, IV-iron or placebo will be prepared for the patient: IV-iron for yellow card; placebo for green cards, respectively.
The study drug will be covered by black-tape by pharmacist and delivered to the operation theater.
IV-iron or placebo will be infused through already established intravenous line within 30 min after anesthesia induction by attending anesthesiologist who is not aware of the patient's group-allocation.
Patient data and statistical analyses:
The information regarding the patient's group allocation will be kept in the pharmacy department till the end of the study and conveyed during the data analyses after completion of the 76th patient participation and discharge.
Patient's data PaO2, FiO2, Hb, intra-op and postop-transfusion amount, intraop- and postop-bleeding amount will be determined from the patients' medical record after patient's discharge.
All statistical analyses will be performed after the 76th patient's discharge and data acquisition.
Surgical procedures:
All surgical procedures will be performed using standardized institutional anesthetic and surgical protocols, antibiotic and antithrombotic prophylaxis, transfusion protocols, and post-operative analgesia.
All TKA will be performed using a pneumatic tourniquet, which is deflated after wound closure. Closed suction drains, which are removed on the second post-operative day, will be placed in all operations.
Transfusion protocol:
Following allogenic blood transfusion protocol will be uniformly applied by anesthesiologists and surgeons to all patients in the operating theater, the post-operative anesthesia care unit, and the ward for the entire duration of hospitalization: blood transfusion of packed RBC will not be performed unless patient's Hb level is < 9 g/dL without any signs and/or symptoms of acute anemia such as hypotension, tachycardia, tachypnea, dizziness, and fatigue.
- Conditions
- Osteoarthritis
- Being tested
- Iron Sucrose 200mg, placebo
- Keywords
- Osteoarthritis, knee arthroplasty, iron
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Sucrose 200mgDrug
Iron Sucrose 200mg is administered after anesthesia induction.
placeboDrug
Also called normal saline
placebo (normal saline) is administered after anesthesia induction
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Iron Sucrose 200mg Receives: Drug: Iron Sucrose 200mg |
| Control Group | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio)
Intergroup-difference in PaO2/FiO2 ratio
Measured: postoperative 24 hour
Secondary outcomes (4)
arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio)
intergroup-difference in PaO2/FiO2 ratio
Measured: postoperative 2 hour
arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio)
intergroup-difference in PaO2/FiO2 ratio
Measured: postoperative 48 hour
serum hemoglobin concentration
serum hemoglobin concentration, g/dL
Measured: postoperative 2 hour
postoperative transfusion red blood cell amount
postoperative transfusion of packed red blood cell, ml
Measured: postoperative 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544828
- Sponsor's protocol ID
- KUH1160093
- Status last verified
- Sep 2015
- First submitted
- 6 Sep 2015
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Intraoperative Intravenous Iron Sucrose Enhance Postoperative Oxygenation Profile in Total Arthroplasty Surgery?
- ClinicalTrials.gov ID
- NCT02544828
- Acronym / sponsor ID
- KUH1160093
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, knee arthroplasty, iron
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 9 Sep 2015 (estimated)
- 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.
The objective of the present study is to determine the impact of intraoperative IV-iron supplementation on postoperative oxygenation profile by comparing the postoperative PaO2/FiO2 ratio with or without IV-iron supplementation in old patients undergoing elective uni-limb arthroplasty surgery.
Detailed description
Participation and recruitment: Patients undergoing elective total knee arthroplasty due to osteroarthritis will be interviewed for participation and recruited after providing written informed consent.
Randomization and group allocation:
All recruited patients will be given patient identification number (PIN) for the present study of 01-76 according to their order of interview and recruitment.
Investigators will prepare 33 yellow and 33 green cards, which will be inserted in 76 thick-paper envelopes. Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 76 (Envelop number).
After printing the envelope number outside envelope, all sealed envelopes with cards will be conveyed to and kept in pharmacy department.
Preparation and Administration of study drug:
Pharmacist will open the envelope with the number same to PIN and check the color of the card inside at study on operation day.
According to the color of the card, IV-iron or placebo will be prepared for the patient: IV-iron for yellow card; placebo for green cards, respectively.
The study drug will be covered by black-tape by pharmacist and delivered to the operation theater.
IV-iron or placebo will be infused through already established intravenous line within 30 min after anesthesia induction by attending anesthesiologist who is not aware of the patient's group-allocation.
Patient data and statistical analyses:
The information regarding the patient's group allocation will be kept in the pharmacy department till the end of the study and conveyed during the data analyses after completion of the 76th patient participation and discharge.
Patient's data PaO2, FiO2, Hb, intra-op and postop-transfusion amount, intraop- and postop-bleeding amount will be determined from the patients' medical record after patient's discharge.
All statistical analyses will be performed after the 76th patient's discharge and data acquisition.
Surgical procedures:
All surgical procedures will be performed using standardized institutional anesthetic and surgical protocols, antibiotic and antithrombotic prophylaxis, transfusion protocols, and post-operative analgesia.
All TKA will be performed using a pneumatic tourniquet, which is deflated after wound closure. Closed suction drains, which are removed on the second post-operative day, will be placed in all operations.
Transfusion protocol:
Following allogenic blood transfusion protocol will be uniformly applied by anesthesiologists and surgeons to all patients in the operating theater, the post-operative anesthesia care unit, and the ward for the entire duration of hospitalization: blood transfusion of packed RBC will not be performed unless patient's Hb level is < 9 g/dL without any signs and/or symptoms of acute anemia such as hypotension, tachycardia, tachypnea, dizziness, and fatigue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Iron Sucrose 200mgIron Sucrose 200mg |
| Control Group | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with osteoarthritis in knee joint undergoing elective uni-limb total knee arthroplasty surgery
- Patients provided a written informed consent.
- Patients with s-ferritin < 300 mg/dl (male) or 200 mg/dl (female)
- Patients with preoperative serum hemoglobin concentration >13 g/dL (male) and >12 g/dL (female)
- Patients with PaO2/FiO2 ratio >150
Key exclusion criteria (3 listed)
- Patients with history of anaphylaxis, iron overload, active infection.
- Patients with endocrine disease
- Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, anti-fibrinolytic agents or recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.
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 |
|---|---|---|
| Iron Sucrose 200mgIron Sucrose 200mg is administered after anesthesia induction. | Drug | Experimental group |
| placeboAlso: normal salineplacebo (normal saline) is administered after anesthesia induction | Drug | Control Group |
Primary outcome
arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio)
Time frame: postoperative 24 hour
Intergroup-difference in PaO2/FiO2 ratio
4 secondary outcomes
arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio)
Time frame: postoperative 2 hour
arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio)
Time frame: postoperative 48 hour
serum hemoglobin concentration
Time frame: postoperative 2 hour
postoperative transfusion red blood cell amount
Time frame: postoperative 24 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iron Sucrose 200mg in people with Osteoarthritis, run by Konkuk University Medical Center.
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 5 inclusion and 3 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 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Tae-Yop Kim, MD, PhD (82-2-2030-5445, taeyop@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio) (time frame: postoperative 24 hour). 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 9 Sep 2015.