Implementation of a Patient Blood Management Program in Gastric Cancer Surgery

NCT04286984 | Completed

• 1 other identifier: IPAT
• Study Type: observational
• Target: 1,063
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Gastric Cancer; Anemia; Intravenous Iron; Patient Blood Management; Surgery

Outcome Measures

Primary Outcomes (1)

• Transfusion Rate

  Percentage of patients receiving any red blood cell trasfusion over the total of patients

  2014-2018

Secondary Outcomes (6)

• Transfusion Index

  2014-2018

• Rate of postoperative complications

  2014-2018

• Readmission rate

  2014-2018

• Length of stay

  2014-2018

• Mortality rate

  2014-2018

Study Arms (2)

Pre-upPBM

Patients with a diagnosis of gastric cancer before the upPBM implementation in their attending center

Post-upPBM

Patients with a diagnosis of gastric cancer after the upPBM implementation in their attending center

Other: unified protocol of Patient Blood Management measure

Interventions

unified protocol of Patient Blood Management measure OTHER

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.

Also known as: upPBM

Post-upPBM

Eligibility Criteria

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

Study Population

Multicenter study on a prospective cohort of consecutive patients undergoing elective gastric cancer resection with curative intent between January 2014 and December 2018 in hospitals of the Spanish EURECCA project which implemented the upPBM before December 31th, 2017, to ensure a minimum 1-year follow-up of upPBM.

You may qualify if:

• \- Patients undergoing elective gastric cancer resection with curative intent between January 2014 and December 2018 in hospitals of the Spanish EURECCA project which implemented the upPBM before December 31th, 2017.

You may not qualify if:

• Metastasis
• Palliative Surgery
• Hospitals non implementing the upPBM before December 31th, 2017

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Related Publications (5)

• Jerico C, Osorio J, Garcia-Erce JA, Pera M. Patient Blood Management strategies for iron deficiency anemia management in gastric cancer. Eur J Gastroenterol Hepatol. 2019 Apr;31(4):547-548. doi: 10.1097/MEG.0000000000001383. No abstract available.

  PMID: 30829765 BACKGROUND

• Messager M, de Steur W, Boelens PG, Jensen LS, Mariette C, Reynolds JV, Osorio J, Pera M, Johansson J, Kolodziejczyk P, Roviello F, De Manzoni G, Monig SP, Allum WH; EURECCA Upper GI group (European Registration of Cancer Care). Description and analysis of clinical pathways for oesophago-gastric adenocarcinoma, in 10 European countries (the EURECCA upper gastro intestinal group - European Registration of Cancer Care). Eur J Surg Oncol. 2016 Sep;42(9):1432-47. doi: 10.1016/j.ejso.2016.01.001. Epub 2016 Feb 6.

  PMID: 26898839 BACKGROUND

• Messager M, de Steur WO, van Sandick JW, Reynolds J, Pera M, Mariette C, Hardwick RH, Bastiaannet E, Boelens PG, van deVelde CJ, Allum WH; EURECCA Upper GI Group. Variations among 5 European countries for curative treatment of resectable oesophageal and gastric cancer: A survey from the EURECCA Upper GI Group (EUropean REgistration of Cancer CAre). Eur J Surg Oncol. 2016 Jan;42(1):116-22. doi: 10.1016/j.ejso.2015.09.017. Epub 2015 Sep 30.

  PMID: 26461256 BACKGROUND

• Allum W, Osorio J. EURECCA oesophago-gastric cancer project. Cir Esp. 2016 May;94(5):255-6. doi: 10.1016/j.ciresp.2015.12.005. Epub 2016 Mar 2. No abstract available. English, Spanish.

  PMID: 26944535 BACKGROUND

• Osorio J, Jerico C, Miranda C, Garsot E, Luna A, Miro M, Santamaria M, Artigau E, Rodriguez-Santiago J, Castro S, Feliu J, Aldeano A, Olona C, Momblan D, Ruiz D, Galofre G, Pros I, Garcia-Albeniz X, Lozano M, Pera M. Perioperative transfusion management in gastric cancer surgery: Analysis of the Spanish subset of the EURECCA oesophago-gastric cancer registry. Cir Esp (Engl Ed). 2018 Nov;96(9):546-554. doi: 10.1016/j.ciresp.2018.03.010. English, Spanish.

  PMID: 29773261 RESULT

MeSH Terms

Conditions

Stomach Neoplasms; Anemia, Iron-Deficiency; Anemia

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Javier Osorio, MD, PhD

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 27, 2020
• Study Start: January 1, 2014
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 2, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2020
• Access Criteria: All responsible surgeons of participant hospitals