Clinical trial · Interventional
Management of Preoperative Anaemia in Surgical Oncology
Management of Preoperative Anaemia in Surgical Oncology as a Tool to Reduce Blood Transfusion Need
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| B12 | Drug | — | UNRESOLVED |
| Ferric Carboxymaltose Injection | Drug | — | UNRESOLVED |
| Folic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cancer patients with anemia (i.e. Hb <12 g/dl if females, <13 g/dL if males)
- description
- 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.
- interventionNames
- Drug: Ferric Carboxymaltose Injection
- Drug: Folic acid
- Drug: B12
Primary outcomes (4)
- measure
- Change in transfusion number compared to a historical cohort of patients enrolled in the three-year period 2017-2019
- timeFrame
- up to 4 weeks after surgery
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Patients with chronic anemia, regularly transfused * Patients with Hemochromatosis
References
Publications (11)
- BACKGROUNDShander 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
- BACKGROUNDMusallam 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
- BACKGROUNDSpahn 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
- BACKGROUNDNess 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
- BACKGROUNDAnthes 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
- BACKGROUNDClevenger 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
- BACKGROUNDVaglio 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.