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Implementation of a Patient Blood Management Program in Gastric Cancer Surgery

NCT04286984 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1063

Last updated 2020-03-02

No results posted yet for this study

Summary

Retrospective evaluation on a prospective cohort of patients undergoing curative gastric cancer resection to evaluate the impact of a patient blood management (PBM) program on transfusion rate and clinical outcomes. The study aims to compare transfusion practices and clinical outcomes of patients undergoing elective gastric cancer resection before and after implementing a PBM program, which included strategies to detect and treat preoperative anemia and restrictive transfusion practice (2014-2018). Primary outcome is transfusion rate (TR). Secondary outcomes are transfusion index (TI), postoperative complications, length of stay, 30-day readmissions, and 90-day mortality. Adherence to protocol is also analyzed. Differences of variables before and after PBM program implementation are evaluated with mean comparing analysis adjusted by confounding factors.

Conditions

  • Gastric Cancer
  • Anemia, Iron Deficiency
  • Surgery--Complications
  • Transfusion Related Complication

Interventions

OTHER

unified protocol of Patient Blood Management measure

upPBM description: After performing a laboratory work-up 2 to 4 weeks before surgery, preoperative iron supplementation in case of iron deficiency anemia at least 7 days before surgery was recommended. Preoperative anemia was defined by a Hb level \< 13 g/dL for both sexes. In anemic patients, iron status study was recommended and iron supplementation with intravenous iron was indicated if Hb\<12g/dL and/or ferritin \<300 mg/l. Intravenous iron (ferric sucrose or carboxymaltose) was administrated with the goal of recovering iron deficit, calculated using the Ganzoni formula or by the simplified strategy, only available for ferric carboxymaltose. Recommended transfusion triggers were: Hb \< 9 g/dL for patients with risk factors and/or anemia symptoms; and Hb \< 7 g/dL for the rest of patients in absence of active bleeding.

Sponsors & Collaborators

  • Hospital Universitari de Bellvitge

    lead OTHER

Principal Investigators

  • Javier Osorio, MD, PhD · Hospital Universitari de Bellvitge

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-01
Primary Completion
2018-12-31
Completion
2018-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04286984 on ClinicalTrials.gov