Anemia and Red Blood Cells Transfusion in Oncological Surgery (IMPACT)

Impact of Perioperative Anemia and Red Blood Cells Transfusion on Post-operative Complications After Oncological Surgery

Oncologic patients experience anemia and anemia is associated with poor prognosis. Transfusion is associated with adverse events, and equipoise remains on the optimal transfusion strategy in oncologic patients in surgical setting. The primary objective of this study is to determine the impact of anemia and red blood cells (RBC) transfusion on post-operative complications and mortality.

Study Overview

• Status: Unknown
• Conditions: Anemia; Surgery; Oncology

Detailed Description

Between 36 and 75% of oncologic patients experience anemia and anemia is associated with poor prognosis. Up to 40% of surgical oncologic patients receive red blood cells (RBC). However, transfusion is associated with adverse events, and equipoise remains on the optimal transfusion strategy in oncologic patients in surgical setting. The primary objective of this study is to determine the impact of anemia and red blood cells (RBC) transfusion on post-operative complications and mortality. This is a retrospective, single center study. All adults admitted to the intensive care unit (ICU) after oncologic surgery within the study period are eligible.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Cécile AUBRON, PU PH; Phone Number: +33298347181; Email: cecile.aubron@chu-brest.fr

Study Locations

• France
  • Brest, France, 29200
    • Recruiting
    • CHRU de Brest, Hôpital de la Cavale Blanche
    • Contact: Cécile AUBRON, PU-PH; Phone Number: +33298347181; Email: cecile.aubron@chu-brest.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adults admitted to the intensive care unit (ICU) after oncologic surgery from January 2017 to December 2018 are eligible. The following types of surgery for cancer or metastasis resection with a high risk of bleeding are eligible: thoracic, abdominal, neurosurgery, gynecologic, urologic, otorhinolaryngology or spinal surgery.

Description

Inclusion Criteria:

• Surgery for cancer
• Admission to intensive care

Exclusion Criteria:

• no consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of mortality or any respiratory, cardiac, renal, thromboembolic, infectious and/or hemorrhagic post operative complications	mortality or any respiratory, cardiac, renal, thromboembolic, infectious and/or hemorrhagic post operative complications	30 DAYS (hospital discharge)

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Cécile AUBRON, PU PH, Service de Médecine Intensive Réanimation

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2019
• Primary Completion (Anticipated): November 30, 2019
• Study Completion (Anticipated): November 30, 2019

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 23, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: red blood cells transfusion
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: IMPACT (29BRC19.0013)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No