Excessive Amount of Blood / Fluid TransfusionNCT01676740
Iron and Vitamin Adminstration Prior to Joint Replacement to Prevent Transfusion
A study testing Iron Supplement, in people with Excessive Amount of Blood / Fluid Transfusion, run by Meir Medical Center at 1 site in Israel.
Trial summary
To establish the efficacy of screening for anemia and treatment of mild anemia with iron and vitamins prior to THR and TKR as a means of increasing hemoglobin and reducing perioperative allogeneic blood transfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Excessive Amount of Blood / Fluid Transfusion
- What is being tested?
- Iron Supplement,
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2012to Feb 2014
- Phase
- Interventional
- 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
Who may be able to join
- Age > 50 years
- Ability to provide informed consent
- Elective THR or TKR
- Mild anemia: Hematocrit 29-39% in men, 29-36% in women
Who cannot join
- Identified cause of anemia excluding hematinic deficiency
- Known source of blood loss
- Known coagulopathy
- Unstable coronary syndrome in the previous 3 months
- Pathologic fracture, presence of malignancy
- Repeat THR or TKR
Show all 13Show fewer
- Orthopedic trauma within the previous 3 months
- ASA class ≥ 4
- Creatinine clearance < 30 ml/min
- AST/ALT > 2x upper limit of normal
- Preexisting use of hematinic agents
- Planned acute normovolemic hemodilution
- Refusal to receive blood products
Trial locations and contacts
1 site in 1 country.
Israel1 site
Meir Medical Center
Kfar Saba, 44281
Martin H Ellis, MD, 972-9-7471822, martinel@clalit.org.il
About this study
Official title: Randomized Ttrial to Establish the Efficacy of Hematinic Agents in Patietns With Mild Anemia Undergoing Total Hip or Knee Replacement in Avoiding Blood Transfusion
To establish the efficacy of screening for anemia and treatment of mild anemia with iron and vitamins prior to THR and TKR as a means of increasing hemoglobin and reducing perioperative allogeneic blood transfusion.
Read the detailed description
Patients with mild anemia will be identified at preoperative clinic visit
- Patients will be screened for inclusion and exclusion criteria
- Eligible patients will have laboratory testing performed as follows: CBC, liver and kidney function tests, serum iron, transferrin, ferritin, serum folic acid, vitamin B12 and C-reactive protein
- Patients will be assigned to a deficient group or non-deficient group depending upon laboratory hematinic values
- Patients in the "non-deficient' group will be randomized using a computer-generated code to treatment or no treatment
- Treatment will begin within 2 weeks of laboratory testing and 4-6 weeks prior to surgery.
- Hematinic therapy will consist of oral ferric hydrochloride polymaltose 200 mg/d and folic acid 0.4 mg/d; sublingual vitamin B12 1000 µg three times a week
- On the day of surgery laboratory testing will be performed as follows: CBC, kidney and liver function tests, serum iron, transferrin, ferritin, serum folic acid, vitamin B12 and C-reactive protein.
- The same surgical team in each center will operate on all study patients and will be blinded to the preoperative hemoglobin
- Routine postoperative management will be provided as determined by the treating physicians
- Blood transfusion will be decided upon by a study physician at each center blinded to the patients' group assignment and preoperative hemoglobin
- The primary outcome will be perioperative blood transfusion (from 24 hours prior to surgery until hospital discharge)
- Secondary outcomes will be length of hospitalization, postoperative wound infection, walking ability across room at 30 days
- Being tested
- Iron Supplement,, Placebo
- Keywords
- hematinic therapy, blood transfusion, joint replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Supplement,Drug
Also called Ferrifol
Pills to be swallowed
PlaceboDrug
Daily administration of active drug or placebo
| Study group | Role | What they receive |
|---|---|---|
| Mild anemia, normal hematinics | Placebo comparator | Mild anemia, normal iron studies, serum folate and vitamin B12 levels - will receive placebo Receives: Drug: Placebo |
| Anemia, normal hematinics | Experimental | Mild anemia, deficient iron, folate or vitamin B12 levels Iron supplement will be given Receives: Drug: Iron Supplement, |
| Deficeicnt hematinics | Other | Iron supplement will be provided Receives: Drug: Iron Supplement, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative blood transfusion
Measured: 1 day prior to surgery until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2013 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Amount of Blood / Fluid TransfusionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Ellis, Meir Medical Center
- Investigators
- Martin H Ellis, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676740
- Sponsor's protocol ID
- MMCHI0112
- Status last verified
- Aug 2012
- First submitted
- 29 Aug 2012
- Last updated
- 3 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Ttrial to Establish the Efficacy of Hematinic Agents in Patietns With Mild Anemia Undergoing Total Hip or Knee Replacement in Avoiding Blood Transfusion
- ClinicalTrials.gov ID
- NCT01676740
- Acronym / sponsor ID
- MMCHI0112
- Keywords
- hematinic therapy, blood transfusion, joint replacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 31 Aug 2012 (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.
To establish the efficacy of screening for anemia and treatment of mild anemia with iron and vitamins prior to THR and TKR as a means of increasing hemoglobin and reducing perioperative allogeneic blood transfusion.
Detailed description
Patients with mild anemia will be identified at preoperative clinic visit
- Patients will be screened for inclusion and exclusion criteria
- Eligible patients will have laboratory testing performed as follows: CBC, liver and kidney function tests, serum iron, transferrin, ferritin, serum folic acid, vitamin B12 and C-reactive protein
- Patients will be assigned to a deficient group or non-deficient group depending upon laboratory hematinic values
- Patients in the "non-deficient' group will be randomized using a computer-generated code to treatment or no treatment
- Treatment will begin within 2 weeks of laboratory testing and 4-6 weeks prior to surgery.
- Hematinic therapy will consist of oral ferric hydrochloride polymaltose 200 mg/d and folic acid 0.4 mg/d; sublingual vitamin B12 1000 µg three times a week
- On the day of surgery laboratory testing will be performed as follows: CBC, kidney and liver function tests, serum iron, transferrin, ferritin, serum folic acid, vitamin B12 and C-reactive protein.
- The same surgical team in each center will operate on all study patients and will be blinded to the preoperative hemoglobin
- Routine postoperative management will be provided as determined by the treating physicians
- Blood transfusion will be decided upon by a study physician at each center blinded to the patients' group assignment and preoperative hemoglobin
- The primary outcome will be perioperative blood transfusion (from 24 hours prior to surgery until hospital discharge)
- Secondary outcomes will be length of hospitalization, postoperative wound infection, walking ability across room at 30 days
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild anemia, normal hematinics | Placebo comparator | Drug: PlaceboMild anemia, normal iron studies, serum folate and vitamin B12 levels - will receive placebo |
| Anemia, normal hematinics | Experimental | Drug: Iron Supplement,Mild anemia, deficient iron, folate or vitamin B12 levels Iron supplement will be given |
| Deficeicnt hematinics | Other | Drug: Iron Supplement,Iron supplement will be provided |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 50 years
- Ability to provide informed consent
- Elective THR or TKR
- Mild anemia: Hematocrit 29-39% in men, 29-36% in women
Key exclusion criteria (13 listed)
- Identified cause of anemia excluding hematinic deficiency
- Known source of blood loss
- Known coagulopathy
- Unstable coronary syndrome in the previous 3 months
- Pathologic fracture, presence of malignancy
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 Supplement,Also: FerrifolPills to be swallowed | Drug | Anemia, normal hematinics, Deficeicnt hematinics |
| PlaceboDaily administration of active drug or placebo | Drug | Mild anemia, normal hematinics |
Primary outcome
Perioperative blood transfusion
Time frame: 1 day prior to surgery until hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2012.
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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.
Martin H Ellis, MD principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron Supplement, in people with Excessive Amount of Blood / Fluid Transfusion, run by Meir Medical Center at 1 site in Israel.
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 4 inclusion and 13 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 3 Sep 2012. 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 Israel. 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. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative blood transfusion (time frame: 1 day prior to surgery until hospital discharge). 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 3 Sep 2012.