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Studies

Interventional Recruiting Phase 4

NCT05505006 on ClinicalTrials.gov

Management of Preoperative Anaemia in Surgical Oncology

Official title: Management of Preoperative Anaemia in Surgical Oncology as a Tool to Reduce Blood Transfusion Need

  • Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
  • Enrollment: 500 (Estimated)
  • Study start: 2021-03-02 (Actual)
  • Primary completion: 2024-08-13 (Estimated)
  • Study completion: 2024-08-13 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • InterventionModelDescription: * 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 B 12 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
  • PrimaryPurpose: Treatment

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

Intervention / Treatment

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

Primary Outcome Measures

  • Change in transfusion number compared to a historical cohort of patients enrolled in the three-year period 2017-2019 (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 (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 (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 (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

Countries

Italy

Locations and Investigators