AnemiaPhase 3FOCUSNCT00071032
Safety and Effectiveness of Two Blood Transfusion Strategies in Surgical Patients With Cardiovascular Disease
A Phase 3 study testing Liberal (10 g/dL) Transfusion Strategy and Restrictive (Symptomatic) Transfusion Strategy in people with Anemia and Hematologic Diseases, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The purpose of this study is to compare liberal red blood cell transfusion therapy with restrictive red blood cell transfusion therapy in surgical patients with cardiovascular disease or risk factors. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Anemia, Hematologic Diseases, Cardiovascular Diseases
- What is being tested?
- Liberal (10 g/dL) Transfusion Strategy and Restrictive (Symptomatic) Transfusion Strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,016 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to May 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has undergone surgical repair for a hip fracture
- Has a postoperative Hgb level below 10 g/dL within three days of surgery
- Diagnosis of cardiovascular disease (e.g., coronary artery disease, congestive heart failure, stroke or transient ischemic attack, or peripheral vascular disease) or cardiovascular risk factors (e.g., diabetes mellitus, hypertension, hypercholesterolemia, tobacco use, or creatinine levels greater than 2.0 mg/dL)
Who cannot join
- Unable to walk prior to hip fracture
- Declines blood transfusions
- Suffered multiple traumas
- Pathologic fracture of the hip due to malignancy
- Clinically recognized acute myocardial infarction within the 30 days prior to study entry
- Previously participated in the trial and fractured the other hip
- Symptoms associated with anemia (e.g., ischemic chest pain) or actively bleeding at the time of randomization
Trial locations and contacts
1 site in 1 country.
United States1 site
University Medicine & Dentistry of NJ
New Brunswick, New Jersey, 08903
About this study
Official title: Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS)
The purpose of this study is to compare liberal red blood cell transfusion therapy with restrictive red blood cell transfusion therapy in surgical patients with cardiovascular disease or risk factors.
Read the detailed description
BACKGROUND:
Red blood cell transfusions are an extremely common medical intervention in both the United States and worldwide; over 14 million units of blood are transfused in the United States. Between 60 and 70 percent of all blood is transfused in the surgical setting. Despite the common use of red blood cell transfusions, the threshold for transfusion has not been adequately evaluated and is very controversial. A decade ago, the standard of care was to administer a peri-operative transfusion whenever the hemoglobin (Hgb) level fell below 10 g/dl (the "10/30 rule"). Concerns about the safety of blood, especially with respect to HIV and hepatitis, and the absence of data to support a 10 g/dl threshold led to the current standard of care, which is to administer blood transfusions based on the presence of symptoms, and not a specific Hgb/hematocrit level. However, there have not been any randomized clinical trials done with surgical patients that have tested the efficacy and safety of withholding blood until the patient develops symptoms, or the "10/30" approach to transfusion. Patients with underlying cardiovascular disease are at greatest risk of adverse effects from reduced Hgb levels.
DESIGN NARRATIVE:
This is a multi-center randomized trial to test the effectiveness of a transfusion strategy that maintains postoperative Hgb levels above 10 g/dl (liberal transfusion) in improving patient outcome. This will be compared to the restrictive (symptomatic) transfusion strategy in which blood transfusion is withheld until the patient develops symptoms of anemia or Hgb less than 8 g/dL. Participants will be randomly assigned to one of the two transfusion strategies. The liberal (10 g/dl) threshold strategy will use enough red blood cell units to maintain Hgb levels at or above 10 g/dl through hospital discharge. Restrictive (Symptomatic) transfusion strategy patients will receive red blood cell transfusions for symptoms of anemia, although transfusion is also permitted, but not required, if the Hgb level falls below 8 g/dl. Outcomes will include functional recovery (primary outcome: ability to walk 10 feet across a room without human assistance or death 60 days post-randomization), lower extremity activities of daily living and instrumental activities of daily living, survival up to 60-days and long-term, disposition (i.e., nursing home placement), and postoperative complications (e.g., myocardial infarction, unstable angina, or death in hospital, pneumonia, wound infection, thromboembolism, stroke).
Ambulation at 60 days is known to be highly predictive of ultimate functional outcome as well as of mortality at one year. Because inability to walk has such important implications for quality of life, and because it is a common problem, it far outweighs the small risk of viral infection or other complications from transfusion in elderly patients.
The trial will also evaluate the effect of transfusion threshold on postoperative risk of acute cardiac ischemia. The strategy will be to enhance surveillance for ischemic events by increasing the number of EKG and serum troponin measurements beyond those already called for in the original FOCUS protocol.
There is an ancillary study to the trial (R01 HL085706) to examine delirium as an outcome in a subsample of 139 patients. We will assess short-term (in hospital) and longer-term (after 30 days) severity of delirium.
- Conditions
- Anemia, Hematologic Diseases, Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Thromboembolism
- Being tested
- Liberal (10 g/dL) Transfusion Strategy, Restrictive (Symptomatic) Transfusion Strategy
- Keywords
- Blood Disease, blood transfusion
- Medical subject headings
- Anemia, Hematologic Diseases, Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Thromboembolism, Pneumonia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberal (10 g/dL) Transfusion StrategyBiological
This transfusion strategy will maintains postoperative Hgb levels above 10 g/dL. This threshold strategy will use enough red blood cell units to maintain Hgb levels at or above 10 g/dL through hospital discharge or up to 30 days after randomization.
Restrictive (Symptomatic) Transfusion StrategyBiological
Transfusion is withheld until the patient develops symptoms from anemia (i.e., chest pain or ECG changes thought to be ischemic, congestive heart failure, unexplained tachycardia or hypotension unresponsive to fluids) or until the hemoglobin level falls below 8 g/dL. Transfusion is permitted, but is not mandatory, if the hemoglobin level falls below 8 g/dL.
| Study group | Role | What they receive |
|---|---|---|
| Liberal (10 g/dL) Transfusion Strategy | Experimental | Transfusion strategy that maintains postoperative Hgb levels above 10 g/dL. Receives: Biological: Liberal (10 g/dL) Transfusion Strategy |
| 2 | Active comparator | Symptomatic transfusion strategy, a more conservative strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia. Receives: Biological: Restrictive (Symptomatic) Transfusion Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death
ascertained via telephone follow-up
Measured: 60 days after randomization
Secondary outcomes (15)
Myocardial Infarction, Unstable Angina, or Death for Any Reason
Measured: In-hospital
Mortality at 30 Days
Measured: 30 days
Mortality at 60 Days
Measured: 60 Days
Composite Outcomes (a) Death, Myocardial Infarction, or Pneumonia and b) Death, Myocardial Infarction, Pneumonia, Thromboembolism, or Stroke
Measured: In-hospital
Myocardial Infarction
Measured: In-hospital
Postoperative Complications (e.g., Wound Infection, Thromboembolism, Stroke)
Measured: In hospital
Disposition Status (i.e., Nursing Home Placement)
Nursing Home Residence
Measured: 60 days
Function - Lower Extremity Activities of Daily Living,at 30 Days
Using the Functional Status Index, score range 0 to 11, higher scores indicate greater dependency
Measured: 30 days
Function - Instrumental Activities of Daily Living, at 30 Days
Using the Older Americans Resources and Services Functional Assessment Questionnaire, score range from 0 to 4, higher scores indicating greater dependency
Measured: 30 days
Function - Fatigue/Energy, at 30 Days
Using the Functional Assessment of Chronic Illnesses Therapy-Fatigue, score range from 0 to 52, higher scores indicating greater level of energy
Measured: 30 days
Function - Lower Extremity Activities of Daily Living. at 60 Days
Scale range 0 to 11, higher scores indicate greater dependency
Measured: 60 Days
Function - Instrumental Activities of Daily Living, at 60 Days
Scale range 0 to 11, higher scores indicate greater dependency
Measured: 60 Days
Function - Fatigue/Energy, at 60 Days
Scale ranging from 0 to 52, higher scores indicating greater level of energy
Measured: 60 Days
Length of Stay in Hospital for United States Participants
Measured: Days from randomization to discharge
Length of Stay in Hospital for Canadian Participants
Measured: Days from randomization to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2003 (estimated)
- Study startJul 2003
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,016 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jeffrey L Carson, MD, Rutgers, The State University of New Jersey
- Investigators
- Jeffrey L. Carson, MD, Study chair, University Medicine & Dentistry of NJMichael Terrin, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071032
- Sponsor's protocol ID
- 159
- Other IDs
- U01HL073958-06, U01HL073958, U01HL074815
- Acronym
- FOCUS
- Status last verified
- Oct 2020
- First submitted
- 9 Oct 2003
- Last updated
- 16 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Carson JL, Terrin ML, Magaziner J, Chaitman BR, Apple FS, Heck DA, Sanders D; FOCUS Investigators. Transfusion trigger trial for functional outcomes in cardiovascular patients undergoing surgical hip fracture repair (FOCUS). Transfusion. 2006 Dec;46(12):2192-206. doi: 10.1111/j.1537-2995.2006.01056.x. No abstract available.
PubMed 17176334Carson JL, Terrin ML, Noveck H, Sanders DW, Chaitman BR, Rhoads GG, Nemo G, Dragert K, Beaupre L, Hildebrand K, Macaulay W, Lewis C, Cook DR, Dobbin G, Zakriya KJ, Apple FS, Horney RA, Magaziner J; FOCUS Investigators. Liberal or restrictive transfusion in high-risk patients after hip surgery. N Engl J Med. 2011 Dec 29;365(26):2453-62. doi: 10.1056/NEJMoa1012452. Epub 2011 Dec 14.
PubMed 22168590Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.
PubMed 41114449Zhang J, Chen Z, He Y. Comparison of liberal versus restrictive transfusion strategies after hip surgery in patients with coronary artery disease: a post hoc analysis of the FOCUS trial. BMC Cardiovasc Disord. 2024 Sep 18;24(1):498. doi: 10.1186/s12872-024-04151-z.
PubMed 39294606Meng L, Wang X, Carson JL, Schlussel Y, Shapses SA. Vitamin D Binding Protein and Postsurgical Outcomes and Tissue Injury Markers After Hip Fracture: A Prospective Study. J Clin Endocrinol Metab. 2023 Dec 21;109(1):e18-e24. doi: 10.1210/clinem/dgad502.
PubMed 37633261Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
PubMed 34932836Carson JL, Sieber F, Cook DR, Hoover DR, Noveck H, Chaitman BR, Fleisher L, Beaupre L, Macaulay W, Rhoads GG, Paris B, Zagorin A, Sanders DW, Zakriya KJ, Magaziner J. Liberal versus restrictive blood transfusion strategy: 3-year survival and cause of death results from the FOCUS randomised controlled trial. Lancet. 2015 Mar 28;385(9974):1183-9. doi: 10.1016/S0140-6736(14)62286-8. Epub 2014 Dec 9.
PubMed 25499165
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS)
- ClinicalTrials.gov ID
- NCT00071032
- Acronym / sponsor ID
- FOCUS / 159
- Conditions
- Anemia, Hematologic Diseases, Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Thromboembolism
- Keywords
- Blood Disease, blood transfusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,016 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2003
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 13 Oct 2003 (estimated)
- Results
- Posted 28 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare liberal red blood cell transfusion therapy with restrictive red blood cell transfusion therapy in surgical patients with cardiovascular disease or risk factors.
Detailed description
BACKGROUND:
Red blood cell transfusions are an extremely common medical intervention in both the United States and worldwide; over 14 million units of blood are transfused in the United States. Between 60 and 70 percent of all blood is transfused in the surgical setting. Despite the common use of red blood cell transfusions, the threshold for transfusion has not been adequately evaluated and is very controversial. A decade ago, the standard of care was to administer a peri-operative transfusion whenever the hemoglobin (Hgb) level fell below 10 g/dl (the "10/30 rule"). Concerns about the safety of blood, especially with respect to HIV and hepatitis, and the absence of data to support a 10 g/dl threshold led to the current standard of care, which is to administer blood transfusions based on the presence of symptoms, and not a specific Hgb/hematocrit level. However, there have not been any randomized clinical trials done with surgical patients that have tested the efficacy and safety of withholding blood until the patient develops symptoms, or the "10/30" approach to transfusion. Patients with underlying cardiovascular disease are at greatest risk of adverse effects from reduced Hgb levels.
DESIGN NARRATIVE:
This is a multi-center randomized trial to test the effectiveness of a transfusion strategy that maintains postoperative Hgb levels above 10 g/dl (liberal transfusion) in improving patient outcome. This will be compared to the restrictive (symptomatic) transfusion strategy in which blood transfusion is withheld until the patient develops symptoms of anemia or Hgb less than 8 g/dL. Participants will be randomly assigned to one of the two transfusion strategies. The liberal (10 g/dl) threshold strategy will use enough red blood cell units to maintain Hgb levels at or above 10 g/dl through hospital discharge. Restrictive (Symptomatic) transfusion strategy patients will receive red blood cell transfusions for symptoms of anemia, although transfusion is also permitted, but not required, if the Hgb level falls below 8 g/dl. Outcomes will include functional recovery (primary outcome: ability to walk 10 feet across a room without human assistance or death 60 days post-randomization), lower extremity activities of daily living and instrumental activities of daily living, survival up to 60-days and long-term, disposition (i.e., nursing home placement), and postoperative complications (e.g., myocardial infarction, unstable angina, or death in hospital, pneumonia, wound infection, thromboembolism, stroke).
Ambulation at 60 days is known to be highly predictive of ultimate functional outcome as well as of mortality at one year. Because inability to walk has such important implications for quality of life, and because it is a common problem, it far outweighs the small risk of viral infection or other complications from transfusion in elderly patients.
The trial will also evaluate the effect of transfusion threshold on postoperative risk of acute cardiac ischemia. The strategy will be to enhance surveillance for ischemic events by increasing the number of EKG and serum troponin measurements beyond those already called for in the original FOCUS protocol.
There is an ancillary study to the trial (R01 HL085706) to examine delirium as an outcome in a subsample of 139 patients. We will assess short-term (in hospital) and longer-term (after 30 days) severity of delirium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal (10 g/dL) Transfusion Strategy | Experimental | Biological: Liberal (10 g/dL) Transfusion StrategyTransfusion strategy that maintains postoperative Hgb levels above 10 g/dL. |
| 2 | Active comparator | Biological: Restrictive (Symptomatic) Transfusion StrategySymptomatic transfusion strategy, a more conservative strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has undergone surgical repair for a hip fracture
- Has a postoperative Hgb level below 10 g/dL within three days of surgery
- Diagnosis of cardiovascular disease (e.g., coronary artery disease, congestive heart failure, stroke or transient ischemic attack, or peripheral vascular disease) or cardiovascular risk factors (e.g., diabetes mellitus, hypertension, hypercholesterolemia, tobacco use, or creatinine levels greater than 2.0 mg/dL)
Key exclusion criteria (7 listed)
- Unable to walk prior to hip fracture
- Declines blood transfusions
- Suffered multiple traumas
- Pathologic fracture of the hip due to malignancy
- Clinically recognized acute myocardial infarction within the 30 days prior to study entry
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 |
|---|---|---|
| Liberal (10 g/dL) Transfusion StrategyThis transfusion strategy will maintains postoperative Hgb levels above 10 g/dL. This threshold strategy will use enough red blood cell units to maintain Hgb levels at or above 10 g/dL through hospital discharge or up to 30 days after randomization. | Biological | Liberal (10 g/dL) Transfusion Strategy |
| Restrictive (Symptomatic) Transfusion StrategyTransfusion is withheld until the patient develops symptoms from anemia (i.e., chest pain or ECG changes thought to be ischemic, congestive heart failure, unexplained tachycardia or hypotension unresponsive to fluids) or until the hemoglobin level falls below 8 g/dL. Transfusion is permitted, but is not mandatory, if the hemoglobin level falls below 8 g/dL. | Biological | 2 |
Primary outcome
Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death
Time frame: 60 days after randomization
ascertained via telephone follow-up
15 secondary outcomes
Myocardial Infarction, Unstable Angina, or Death for Any Reason
Time frame: In-hospital
Mortality at 30 Days
Time frame: 30 days
Mortality at 60 Days
Time frame: 60 Days
Composite Outcomes (a) Death, Myocardial Infarction, or Pneumonia and b) Death, Myocardial Infarction, Pneumonia, Thromboembolism, or Stroke
Time frame: In-hospital
Myocardial Infarction
Time frame: In-hospital
Postoperative Complications (e.g., Wound Infection, Thromboembolism, Stroke)
Time frame: In hospital
Disposition Status (i.e., Nursing Home Placement)
Time frame: 60 days
Function - Lower Extremity Activities of Daily Living,at 30 Days
Time frame: 30 days
Function - Instrumental Activities of Daily Living, at 30 Days
Time frame: 30 days
Function - Fatigue/Energy, at 30 Days
Time frame: 30 days
Function - Lower Extremity Activities of Daily Living. at 60 Days
Time frame: 60 Days
Function - Instrumental Activities of Daily Living, at 60 Days
Time frame: 60 Days
Function - Fatigue/Energy, at 60 Days
Time frame: 60 Days
Length of Stay in Hospital for United States Participants
Time frame: Days from randomization to discharge
Length of Stay in Hospital for Canadian Participants
Time frame: Days from randomization to discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17176334Carson JL, Terrin ML, Magaziner J, Chaitman BR, Apple FS, Heck DA, Sanders D; FOCUS Investigators. Transfusion trigger trial for functional outcomes in cardiovascular patients undergoing surgical hip fracture repair (FOCUS). Transfusion. 2006 Dec;46(12):2192-206. doi: 10.1111/j.1537-2995.2006.01056.x. No abstract available.
- Results publication: PubMed 22168590Carson JL, Terrin ML, Noveck H, Sanders DW, Chaitman BR, Rhoads GG, Nemo G, Dragert K, Beaupre L, Hildebrand K, Macaulay W, Lewis C, Cook DR, Dobbin G, Zakriya KJ, Apple FS, Horney RA, Magaziner J; FOCUS Investigators. Liberal or restrictive transfusion in high-risk patients after hip surgery. N Engl J Med. 2011 Dec 29;365(26):2453-62. doi: 10.1056/NEJMoa1012452. Epub 2011 Dec 14.
- Derived from this study: PubMed 41114449Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.
- Derived from this study: PubMed 39294606Zhang J, Chen Z, He Y. Comparison of liberal versus restrictive transfusion strategies after hip surgery in patients with coronary artery disease: a post hoc analysis of the FOCUS trial. BMC Cardiovasc Disord. 2024 Sep 18;24(1):498. doi: 10.1186/s12872-024-04151-z.
- Derived from this study: PubMed 37633261Meng L, Wang X, Carson JL, Schlussel Y, Shapses SA. Vitamin D Binding Protein and Postsurgical Outcomes and Tissue Injury Markers After Hip Fracture: A Prospective Study. J Clin Endocrinol Metab. 2023 Dec 21;109(1):e18-e24. doi: 10.1210/clinem/dgad502.
- Derived from this study: PubMed 34932836Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
- Derived from this study: PubMed 25499165Carson JL, Sieber F, Cook DR, Hoover DR, Noveck H, Chaitman BR, Fleisher L, Beaupre L, Macaulay W, Rhoads GG, Paris B, Zagorin A, Sanders DW, Zakriya KJ, Magaziner J. Liberal versus restrictive blood transfusion strategy: 3-year survival and cause of death results from the FOCUS randomised controlled trial. Lancet. 2015 Mar 28;385(9974):1183-9. doi: 10.1016/S0140-6736(14)62286-8. Epub 2014 Dec 9.
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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.
Jeffrey L. Carson, MD study chair
University Medicine & Dentistry of NJ
Michael Terrin principal investigator
University of Maryland, College Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liberal (10 g/dL) Transfusion Strategy and Restrictive (Symptomatic) Transfusion Strategy in people with Anemia and Hematologic Diseases, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 3 inclusion and 7 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 16 Nov 2020. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (time frame: 60 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00071032, which also lists 7 linked publications.
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 16 Nov 2020.