AnemiaPhase 4NCT05505006
Management of Preoperative Anaemia in Surgical Oncology
A Phase 4 study testing Ferric Carboxymaltose Injection, Folic acid and B12 in people with Anemia and Tumor, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial summary
Preoperative anemia is detrimental in surgical patients, and its treatment with transfusions can further worsen outcomes, including increased hospital stay and mortality. Transfusions are also highly costly. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Ferric Carboxymaltose Injection, Folic acid and B12
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 2 Mar 2021to 13 Aug 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signature of informed consent
- Eligibility to elective surgery for malignant oncological pathology.
- Presence of pre-operative anemia (Hb <12 g/dL females, <13 g/dL males)
- Age >=18 years
Who cannot join
- Patients with chronic anemia, regularly transfused
- Patients with Hemochromatosis
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, 37134
Domenico Girelli, Prof., + 39 0458124262, domenico.girelli@aovr.veneto.it
Domenico Girelli, Prof.
About this study
Official title: Management of Preoperative Anaemia in Surgical Oncology as a Tool to Reduce Blood Transfusion Need
Preoperative anemia is detrimental in surgical patients, and its treatment with transfusions can further worsen outcomes, including increased hospital stay and mortality. Transfusions are also highly costly. In 2010, the World Health Organization endorsed the adoption of Patient Blood Management (PBM) programs, i.e., patient-centered multidisciplinary activities, including recognition and treatment of preoperative anemia. While the latter has been proved effective in reducing transfusions in setting like elective orthopedic surgery, widespread adoption is still lacking. Moreover, little is known about surgical oncology, a particular setting posing unique challenging. This change-promoting project attempts to fill this knowledge gap by establishing a multidisciplinary team aimed at optimal management of preoperative anemia in hepatobiliary/pancreas/gastrointestinal/renal surgical oncology. The primary endpoint is the reduction of transfusions, along with safer patient outcomes as compared to the historical series.
Read the detailed description
BACKGROUND: Preoperative anemia is frequent in patients undergoing major surgery, varying from nearly 35% in elective orthopedic surgery (EOS) to >75% in colon cancer. Mounting data have shown that anemia is independently associated with an increased risk of morbidity and mortality in surgical patients. This is true even for mild-degree anemia, which is frequently overlooked. Of note, treatment of anemia with transfusions does not ameliorate the risk but instead appears to raise further perioperative morbidity, hospital length of stay, and mortality. Transfusions have adverse immunomodulatory effects that can increase infectious complications or cancer recurrence. Indeed, it is increasingly recognized that transfusions are one of the most costly and overused treatments in modern medicine. This has led to the implementation of Patient Blood Management (PBM) programs, i.e., patient-centered, multidisciplinary activities to promote safe and evidence-based use of transfusions. Recognition and treatment of preoperative anemia is a significant pillar of PBM, with proven efficacy in certain types of surgery, i.e., EOS. This has been facilitated by recent advances in the knowledge of the pathophysiology of iron, whose deficiency represents a common and treatable form of anemia in surgical patients. Nevertheless, evidence is scanty in surgical patients with malignancies, a particular subgroup that poses unique challenges.
Hypothesis and Significance: Recognition and treatment of preoperative anemia in surgical oncology through a well-organized, multidisciplinary Anemia Clinic should decrease blood transfusions, ultimately leading to better clinical outcomes and cost savings.
METHODOLOGIES and STATISTICAL ANALYSES: Evaluation and treatment of preoperative anemia will be performed as follows: we will perform a minimum panel of exams, i.e., complete blood count (CBC), creatinine, C-reactive protein, ferritin, transferrin saturation (TSAT), and circulating folate/B12 levels, to assess the presence of anemia, and to identify potentially correctable causes. On the same day on which the patient performs lab analyses in the morning, the surgeon will alert the Anemia Clinic with the patient's ID digital code. Case-manager MD at Anemia Clinic will evaluate lab results as soon they become available (expected time 3-4 hours after blood drawing) through the e-health system. Anemic patients will be invited to attend the Anemia Clinic the day after. They will be clinically evaluated, and treatment for anemia will be immediately prescribed/performed.
Core statistical analyses regarding transfusion use and patients' outcomes will be entrusted to external independent statisticians through subcontract. The diagnostic performance of hepcidin will be investigated through Area Under the Curve Receiving Operating Characteristic (AUC-ROC) and its prognostic implications by Kaplan-Meier curves.
The duration of the presented project is calculated as 36 months and will be divided into 3 different milestones as follows:
- M1: Study organization and coordination among the Units (study protocol preparation, procedures implementation for managing patient flow across units).
- M2: 24 months of Patient Enrolment (evaluation of preoperative hematological parameters and suitable treatment, surgery, postoperative evaluation) and ad interim follow-up evaluation after 1 month from the surgery.
- M3: statistical evaluation of results, publication preparation, and evaluation of the possible implementation of new improved internal guidelines for treating anemia in cancer patients.
- Being tested
- Ferric Carboxymaltose Injection, Folic acid, B12
- Keywords
- anemia, surgical oncology, transfusion, patient blood management
- Medical subject headings
- Anemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric Carboxymaltose InjectionDrug
Also called i.v. iron
Anemic patients with ID will receive i.v. iron. Dosage will be based on Hb level and patient body weight.
Folic acidDrug
Also called Folate
Anemic patients with folate deficiency will receive folic acid 5 mg per day for 1 month
B12Drug
Also called cobalamin
Anemic patients with B12 deficiency will receive B vitamin complex 1 tablet per day for 1 month
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients with anemia (i.e. Hb <12 g/dl if females, <13 g/dL if males) | Experimental | Cancer patients eligible for surgery with anemia will be managed as follows:
* s-ferritin <100 mcg/l or s-ferritin <500 mcg/l + TSAT<20% = i.v. iron (ferric carboxymaltose, dosage according to body weight and Hb level)
* folate < 5 ng/ml = folate 5 mg per day for 1 month
* B12 < 200 pg/ml = B vitamin complex 1 tablet per day for 1 month
Patients will receive combined treatment if they have multiple deficiencies simultaneously.
Patients without correctable deficiencies will not receive any treatment. Receives: Drug: Ferric Carboxymaltose Injection; Drug: Folic acid; Drug: B12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in transfusion number compared to a historical cohort of patients enrolled in the three-year period 2017-2019
Evaluate whether implementing a program for early recognition and management of preoperative anemia leads to a reduction in blood transfusions in surgical oncology compared to historical cohort enrolled before the project
Measured: up to 4 weeks after surgery
Change in short-term (30 days) patients' outcomes (perioperative complications including infections, cardiovascular events, and mortality) compared to a historical cohort of patients enrolled in the three years 2017-2019
Evaluate whether implementing a program for early recognition and management of preoperative anemia leads to an improvement in some patient's clinical outcomes after surgery compared to the historical cohort enrolled before the project
Measured: up to 4 weeks after surgery
Change in length of stay in hospital compared to a historical cohort of patients enrolled in the three-year period 2017-2019
Evaluate whether implementing a program for early recognition and management of preoperative anemia leads to a shortening in the duration of hospitalization after surgery compared to the historical cohort enrolled before the project
Measured: up to 4 weeks after surgery
Change in Hb levels (g/dl) at discharge compared to a historical cohort of patients enrolled in the three-year period 2017-2019
Evaluate whether implementing a program for early recognition and management of preoperative anemia leads to an improvement in Hb levels at discharge compared to the historical cohort enrolled before the project
Measured: up to 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start2 Mar 2021
- Primary completion13 Aug 2024 (estimated)
- Study completion13 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- * Institution of an Anemia Clinic to identify all cancer patients with anemia before surgery * Treatment of treatable causes of anemia in all cancer patients within three weeks before surgery; in particular, iron deficiency (ID), folate deficiency and B12 deficiency * Collection of data concerning transfusions in the peri-operative period * Collection of peri-operative outcomes such as in-hospital mortality, myocardial infarction, ischemic stroke, acute renal failure, pneumonia, or sepsis, and Hb levels at discharge * Comparison of data relating to transfusions and outcomes with those obtained in a historical cohort of anemic patients eligible for oncological surgery for malignant tumors, matched by age, sex, and pathology enrolled in the three years 2017-2019 * Evaluation of hepcidin levels in anemic cancer patients (explorative aim)
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabiana Busti, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505006
- Sponsor's protocol ID
- CO-2016-02361206
- Status last verified
- Aug 2022
- First submitted
- 11 Aug 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shander A, Knight K, Thurer R, Adamson J, Spence R. Prevalence and outcomes of anemia in surgery: a systematic review of the literature. Am J Med. 2004 Apr 5;116 Suppl 7A:58S-69S. doi: 10.1016/j.amjmed.2003.12.013.
PubMed 15050887Musallam KM, Tamim HM, Richards T, Spahn DR, Rosendaal FR, Habbal A, Khreiss M, Dahdaleh FS, Khavandi K, Sfeir PM, Soweid A, Hoballah JJ, Taher AT, Jamali FR. Preoperative anaemia and postoperative outcomes in non-cardiac surgery: a retrospective cohort study. Lancet. 2011 Oct 15;378(9800):1396-407. doi: 10.1016/S0140-6736(11)61381-0. Epub 2011 Oct 5.
PubMed 21982521Spahn DR. Patient Blood Management: Success and Potential in the Future. Ann Surg. 2016 Aug;264(2):212-3. doi: 10.1097/SLA.0000000000001787. No abstract available.
PubMed 27163953Ness PM, Frank SM. Enhancing patient blood management: a long-term FOCUS. Lancet. 2015 Mar 28;385(9974):1157-9. doi: 10.1016/S0140-6736(14)62344-8. Epub 2014 Dec 9. No abstract available.
PubMed 25499166Anthes E. Evidence-based medicine: Save blood, save lives. Nature. 2015 Apr 2;520(7545):24-6. doi: 10.1038/520024a. No abstract available.
PubMed 25832389Clevenger B, Mallett SV, Klein AA, Richards T. Patient blood management to reduce surgical risk. Br J Surg. 2015 Oct;102(11):1325-37; discussion 1324. doi: 10.1002/bjs.9898. Epub 2015 Aug 27.
PubMed 26313653Vaglio S, Prisco D, Biancofiore G, Rafanelli D, Antonioli P, Lisanti M, Andreani L, Basso L, Velati C, Grazzini G, Liumbruno GM. Recommendations for the implementation of a Patient Blood Management programme. Application to elective major orthopaedic surgery in adults. Blood Transfus. 2016 Jan;14(1):23-65. doi: 10.2450/2015.0172-15. Epub 2015 Dec 15. No abstract available.
PubMed 26710356Girelli D, Nemeth E, Swinkels DW. Hepcidin in the diagnosis of iron disorders. Blood. 2016 Jun 9;127(23):2809-13. doi: 10.1182/blood-2015-12-639112. Epub 2016 Apr 4.
PubMed 27044621Gross I, Trentino KM, Andreescu A, Pierson R, Maietta RA, Farmer S. Impact of a Patient Blood Management Program and an Outpatient Anemia Management Protocol on Red Cell Transfusions in Oncology Inpatients and Outpatients. Oncologist. 2016 Mar;21(3):327-32. doi: 10.1634/theoncologist.2015-0406. Epub 2016 Feb 10.
PubMed 26865590Froessler B, Palm P, Weber I, Hodyl NA, Singh R, Murphy EM. The Important Role for Intravenous Iron in Perioperative Patient Blood Management in Major Abdominal Surgery: A Randomized Controlled Trial. Ann Surg. 2016 Jul;264(1):41-6. doi: 10.1097/SLA.0000000000001646.
PubMed 26817624Calleja JL, Delgado S, del Val A, Hervas A, Larraona JL, Teran A, Cucala M, Mearin F; Colon Cancer Study Group. Ferric carboxymaltose reduces transfusions and hospital stay in patients with colon cancer and anemia. Int J Colorectal Dis. 2016 Mar;31(3):543-51. doi: 10.1007/s00384-015-2461-x. Epub 2015 Dec 22.
PubMed 26694926
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Preoperative Anaemia in Surgical Oncology as a Tool to Reduce Blood Transfusion Need
- ClinicalTrials.gov ID
- NCT05505006
- Acronym / sponsor ID
- CO-2016-02361206
- Keywords
- anemia, surgical oncology, transfusion, patient blood management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 13 Aug 2024 (estimated)
- Study completion
- 13 Aug 2024 (estimated)
- First posted
- 17 Aug 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.
Preoperative anemia is detrimental in surgical patients, and its treatment with transfusions can further worsen outcomes, including increased hospital stay and mortality. Transfusions are also highly costly. In 2010, the World Health Organization endorsed the adoption of Patient Blood Management (PBM) programs, i.e., patient-centered multidisciplinary activities, including recognition and treatment of preoperative anemia. While the latter has been proved effective in reducing transfusions in setting like elective orthopedic surgery, widespread adoption is still lacking. Moreover, little is known about surgical oncology, a particular setting posing unique challenging. This change-promoting project attempts to fill this knowledge gap by establishing a multidisciplinary team aimed at optimal management of preoperative anemia in hepatobiliary/pancreas/gastrointestinal/renal surgical oncology. The primary endpoint is the reduction of transfusions, along with safer patient outcomes as compared to the historical series.
Detailed description
BACKGROUND: Preoperative anemia is frequent in patients undergoing major surgery, varying from nearly 35% in elective orthopedic surgery (EOS) to >75% in colon cancer. Mounting data have shown that anemia is independently associated with an increased risk of morbidity and mortality in surgical patients. This is true even for mild-degree anemia, which is frequently overlooked. Of note, treatment of anemia with transfusions does not ameliorate the risk but instead appears to raise further perioperative morbidity, hospital length of stay, and mortality. Transfusions have adverse immunomodulatory effects that can increase infectious complications or cancer recurrence. Indeed, it is increasingly recognized that transfusions are one of the most costly and overused treatments in modern medicine. This has led to the implementation of Patient Blood Management (PBM) programs, i.e., patient-centered, multidisciplinary activities to promote safe and evidence-based use of transfusions. Recognition and treatment of preoperative anemia is a significant pillar of PBM, with proven efficacy in certain types of surgery, i.e., EOS. This has been facilitated by recent advances in the knowledge of the pathophysiology of iron, whose deficiency represents a common and treatable form of anemia in surgical patients. Nevertheless, evidence is scanty in surgical patients with malignancies, a particular subgroup that poses unique challenges.
Hypothesis and Significance: Recognition and treatment of preoperative anemia in surgical oncology through a well-organized, multidisciplinary Anemia Clinic should decrease blood transfusions, ultimately leading to better clinical outcomes and cost savings.
METHODOLOGIES and STATISTICAL ANALYSES: Evaluation and treatment of preoperative anemia will be performed as follows: we will perform a minimum panel of exams, i.e., complete blood count (CBC), creatinine, C-reactive protein, ferritin, transferrin saturation (TSAT), and circulating folate/B12 levels, to assess the presence of anemia, and to identify potentially correctable causes. On the same day on which the patient performs lab analyses in the morning, the surgeon will alert the Anemia Clinic with the patient's ID digital code. Case-manager MD at Anemia Clinic will evaluate lab results as soon they become available (expected time 3-4 hours after blood drawing) through the e-health system. Anemic patients will be invited to attend the Anemia Clinic the day after. They will be clinically evaluated, and treatment for anemia will be immediately prescribed/performed.
Core statistical analyses regarding transfusion use and patients' outcomes will be entrusted to external independent statisticians through subcontract. The diagnostic performance of hepcidin will be investigated through Area Under the Curve Receiving Operating Characteristic (AUC-ROC) and its prognostic implications by Kaplan-Meier curves.
The duration of the presented project is calculated as 36 months and will be divided into 3 different milestones as follows:
- M1: Study organization and coordination among the Units (study protocol preparation, procedures implementation for managing patient flow across units).
- M2: 24 months of Patient Enrolment (evaluation of preoperative hematological parameters and suitable treatment, surgery, postoperative evaluation) and ad interim follow-up evaluation after 1 month from the surgery.
- M3: statistical evaluation of results, publication preparation, and evaluation of the possible implementation of new improved internal guidelines for treating anemia in cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- * Institution of an Anemia Clinic to identify all cancer patients with anemia before surgery * Treatment of treatable causes of anemia in all cancer patients within three weeks before surgery; in particular, iron deficiency (ID), folate deficiency and B12 deficiency * Collection of data concerning transfusions in the peri-operative period * Collection of peri-operative outcomes such as in-hospital mortality, myocardial infarction, ischemic stroke, acute renal failure, pneumonia, or sepsis, and Hb levels at discharge * Comparison of data relating to transfusions and outcomes with those obtained in a historical cohort of anemic patients eligible for oncological surgery for malignant tumors, matched by age, sex, and pathology enrolled in the three years 2017-2019 * Evaluation of hepcidin levels in anemic cancer patients (explorative aim)
| Arm | Type | Receives |
|---|---|---|
| Cancer patients with anemia (i.e. Hb <12 g/dl if females, <13 g/dL if males) | Experimental | Drug: Ferric Carboxymaltose Injection, Drug: Folic acid, Drug: B12Cancer patients eligible for surgery with anemia will be managed as follows: * s-ferritin <100 mcg/l or s-ferritin <500 mcg/l + TSAT<20% = i.v. iron (ferric carboxymaltose, dosage according to body weight and Hb level) * folate < 5 ng/ml = folate 5 mg per day for 1 month * B12 < 200 pg/ml = B vitamin complex 1 tablet per day for 1 month Patients will receive combined treatment if they have multiple deficiencies simultaneously. Patients without correctable deficiencies will not receive any treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signature of informed consent
- Eligibility to elective surgery for malignant oncological pathology.
Key exclusion criteria (2 listed)
- Patients with chronic anemia, regularly transfused
- Patients with Hemochromatosis
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 |
|---|---|---|
| Ferric Carboxymaltose InjectionAlso: i.v. ironAnemic patients with ID will receive i.v. iron. Dosage will be based on Hb level and patient body weight. | Drug | Cancer patients with anemia (i.e. Hb <12 g/dl if females, <13 g/dL if males) |
| Folic acidAlso: FolateAnemic patients with folate deficiency will receive folic acid 5 mg per day for 1 month | Drug | Cancer patients with anemia (i.e. Hb <12 g/dl if females, <13 g/dL if males) |
| B12Also: cobalaminAnemic patients with B12 deficiency will receive B vitamin complex 1 tablet per day for 1 month | Drug | Cancer patients with anemia (i.e. Hb <12 g/dl if females, <13 g/dL if males) |
Primary outcome
Change in transfusion number compared to a historical cohort of patients enrolled in the three-year period 2017-2019
Time frame: up to 4 weeks after surgery
Evaluate whether implementing a program for early recognition and management of preoperative anemia leads to a reduction in blood transfusions in surgical oncology compared to historical cohort enrolled before the project
Change in short-term (30 days) patients' outcomes (perioperative complications including infections, cardiovascular events, and mortality) compared to a historical cohort of patients enrolled in the three years 2017-2019
Time frame: up to 4 weeks after surgery
Evaluate whether implementing a program for early recognition and management of preoperative anemia leads to an improvement in some patient's clinical outcomes after surgery compared to the historical cohort enrolled before the project
Change in length of stay in hospital compared to a historical cohort of patients enrolled in the three-year period 2017-2019
Time frame: up to 4 weeks after surgery
Evaluate whether implementing a program for early recognition and management of preoperative anemia leads to a shortening in the duration of hospitalization after surgery compared to the historical cohort enrolled before the project
Change in Hb levels (g/dl) at discharge compared to a historical cohort of patients enrolled in the three-year period 2017-2019
Time frame: up to 4 weeks after surgery
Evaluate whether implementing a program for early recognition and management of preoperative anemia leads to an improvement in Hb levels at discharge compared to the historical cohort enrolled before the project
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Background: PubMed 15050887Shander A, Knight K, Thurer R, Adamson J, Spence R. Prevalence and outcomes of anemia in surgery: a systematic review of the literature. Am J Med. 2004 Apr 5;116 Suppl 7A:58S-69S. doi: 10.1016/j.amjmed.2003.12.013.
- Background: PubMed 21982521Musallam KM, Tamim HM, Richards T, Spahn DR, Rosendaal FR, Habbal A, Khreiss M, Dahdaleh FS, Khavandi K, Sfeir PM, Soweid A, Hoballah JJ, Taher AT, Jamali FR. Preoperative anaemia and postoperative outcomes in non-cardiac surgery: a retrospective cohort study. Lancet. 2011 Oct 15;378(9800):1396-407. doi: 10.1016/S0140-6736(11)61381-0. Epub 2011 Oct 5.
- Background: PubMed 27163953Spahn DR. Patient Blood Management: Success and Potential in the Future. Ann Surg. 2016 Aug;264(2):212-3. doi: 10.1097/SLA.0000000000001787. No abstract available.
- Background: PubMed 25499166Ness PM, Frank SM. Enhancing patient blood management: a long-term FOCUS. Lancet. 2015 Mar 28;385(9974):1157-9. doi: 10.1016/S0140-6736(14)62344-8. Epub 2014 Dec 9. No abstract available.
- Background: PubMed 25832389Anthes E. Evidence-based medicine: Save blood, save lives. Nature. 2015 Apr 2;520(7545):24-6. doi: 10.1038/520024a. No abstract available.
- Background: PubMed 26313653Clevenger B, Mallett SV, Klein AA, Richards T. Patient blood management to reduce surgical risk. Br J Surg. 2015 Oct;102(11):1325-37; discussion 1324. doi: 10.1002/bjs.9898. Epub 2015 Aug 27.
- Background: PubMed 26710356Vaglio S, Prisco D, Biancofiore G, Rafanelli D, Antonioli P, Lisanti M, Andreani L, Basso L, Velati C, Grazzini G, Liumbruno GM. Recommendations for the implementation of a Patient Blood Management programme. Application to elective major orthopaedic surgery in adults. Blood Transfus. 2016 Jan;14(1):23-65. doi: 10.2450/2015.0172-15. Epub 2015 Dec 15. No abstract available.
- Background: PubMed 27044621Girelli D, Nemeth E, Swinkels DW. Hepcidin in the diagnosis of iron disorders. Blood. 2016 Jun 9;127(23):2809-13. doi: 10.1182/blood-2015-12-639112. Epub 2016 Apr 4.
- Background: PubMed 26865590Gross I, Trentino KM, Andreescu A, Pierson R, Maietta RA, Farmer S. Impact of a Patient Blood Management Program and an Outpatient Anemia Management Protocol on Red Cell Transfusions in Oncology Inpatients and Outpatients. Oncologist. 2016 Mar;21(3):327-32. doi: 10.1634/theoncologist.2015-0406. Epub 2016 Feb 10.
- Background: PubMed 26817624Froessler B, Palm P, Weber I, Hodyl NA, Singh R, Murphy EM. The Important Role for Intravenous Iron in Perioperative Patient Blood Management in Major Abdominal Surgery: A Randomized Controlled Trial. Ann Surg. 2016 Jul;264(1):41-6. doi: 10.1097/SLA.0000000000001646.
- Background: PubMed 26694926Calleja JL, Delgado S, del Val A, Hervas A, Larraona JL, Teran A, Cucala M, Mearin F; Colon Cancer Study Group. Ferric carboxymaltose reduces transfusions and hospital stay in patients with colon cancer and anemia. Int J Colorectal Dis. 2016 Mar;31(3):543-51. doi: 10.1007/s00384-015-2461-x. Epub 2015 Dec 22.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric Carboxymaltose Injection, Folic acid and B12 in people with Anemia and Tumor, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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 2 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 19 Aug 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 Italy. 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 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 Domenico Girelli, MD (+39 0458125262, domenico.girelli@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in transfusion number compared to a historical cohort of patients enrolled in the three-year period 2017-2019 (time frame: up to 4 weeks after surgery). The study lists 4 primary outcomes in all. 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 NCT05505006, which also lists 11 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 19 Aug 2022.