Management of Preoperative Anaemia in Surgical Oncology

NCT05505006 | Unknown Phase 4 DMC

• 1 other identifier: CO-2016-02361206
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anemia; Tumor

Keywords

anemia; surgical oncology; transfusion; patient blood management

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  up to 4 weeks after surgery

Other Outcomes (1)

• To evaluate the role of hepcidin in the pathophysiology of cancer-related anemia, and its potential role as prognostic parameter and in predicting the response to iron therapy

  at patient enrollment and at hospital admission

Study Arms (1)

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.

Drug: Ferric Carboxymaltose Injection; Drug: Folic acid; Drug: B12

Interventions

Ferric Carboxymaltose Injection DRUG

Anemic patients with ID will receive i.v. iron. Dosage will be based on Hb level and patient body weight.

Also known as: i.v. iron

Cancer patients with anemia (i.e. Hb <12 g/dl if females, <13 g/dL if males)

Folic acid DRUG

Anemic patients with folate deficiency will receive folic acid 5 mg per day for 1 month

Also known as: Folate

Cancer patients with anemia (i.e. Hb <12 g/dl if females, <13 g/dL if males)

B12 DRUG

Anemic patients with B12 deficiency will receive B vitamin complex 1 tablet per day for 1 month

Also known as: cobalamin

Cancer patients with anemia (i.e. Hb <12 g/dl if females, <13 g/dL if males)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with chronic anemia, regularly transfused
• Patients with Hemochromatosis

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, 37134, Italy

RECRUITING

Related Publications (11)

• 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.

  PMID: 15050887 BACKGROUND

• Musallam 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.

  PMID: 21982521 BACKGROUND

• Spahn 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.

  PMID: 27163953 BACKGROUND

• Ness 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.

  PMID: 25499166 BACKGROUND

• Anthes E. Evidence-based medicine: Save blood, save lives. Nature. 2015 Apr 2;520(7545):24-6. doi: 10.1038/520024a. No abstract available.

  PMID: 25832389 BACKGROUND

• Clevenger 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.

  PMID: 26313653 BACKGROUND

• Vaglio 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.

  PMID: 26710356 BACKGROUND

• Girelli 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.

  PMID: 27044621 BACKGROUND

• Gross 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.

  PMID: 26865590 BACKGROUND

• Froessler 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.

  PMID: 26817624 BACKGROUND

• Calleja 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.

  PMID: 26694926 BACKGROUND

MeSH Terms

Conditions

Anemia; Neoplasms

Interventions

ferric carboxymaltose; Folic Acid; Vitamin B 12

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds, 4 or More Rings; Macrocyclic Compounds; Polycyclic Compounds

Central Study Contacts

Domenico Girelli, MD

CONTACT

+39 0458125262; domenico.girelli@univr.it

Fabiana Busti, MD

CONTACT

+ 39 0458126030; fabiana.busti@univr.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical researcher

Model Details: * 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)

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 17, 2022
• Study Start: March 2, 2021
• Primary Completion: August 13, 2024
• Study Completion: August 13, 2024
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)