- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06928558
Preoperative Anemia in the Oncology Population and Associated Mortality
April 7, 2025 updated by: Roberto Gonzalez Cornejo, University of Chile
Prevalence of Preoperative Anemia in the Oncology Population and Associated Mortality
Anemia is a highly prevalent condition in the surgical population (1, 2).
On the other hand, the oncology population is at higher risk of developing anemia due to specific treatments for the disease, such as chemotherapy and radiotherapy.
Preoperative anemia has been associated with an increased risk of postoperative morbidity and even mortality (3).
Despite this, the prevalence of preoperative anemia in the Chilean oncology population has not been quantified.
To answer this question, a retrospective cohort study was designed between January and December 2022 to quantify the prevalence of anemia in the surgical population of the National Cancer Institute.
In addition, the impact on morbidity and mortality at 30 days, 6 months, and 1 year will be evaluated.
Statistical analysis will be performed using R. Studio Version 2023.09.1+494 (2023.09.1+494).
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
General Objective:
To quantify the prevalence of preoperative anemia in the National Cancer Institute's oncology surgical population and its impact on postoperative outcomes.
Specific Objectives:
- To quantify the prevalence of preoperative anemia in the National Cancer Institute's oncology population.
- To stratify the prevalence of preoperative anemia in the National Cancer Institute's oncology population by severity.
- To assess 30-day, 6-month, and 1-year mortality in cancer patients with and without anemia in the National Cancer Institute's oncology population.
Study Type
Observational
Enrollment (Estimated)
850
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Roberto A González, MD
- Phone Number: +56999397515
- Email: robgonzalez@uchile.cl
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Consecutive patients operated at the National Cancer Institute will be included in a retrospective cohort study between January and December 2022.
Description
Inclusion Criteria:
- Patients over 18 years of age
- Oncologic surgery with curative intent
Exclusion Criteria:
- Emergency surgery
- Patients who received a preoperative transfusion
- Patients without a preoperative blood count
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Surgical oncology patients
Oncology patients over 18 years of age, scheduled for surgery with curative intent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of preoperative anemia
Time Frame: 1 year
|
To quantify the prevalence of preoperative anemia in the oncology surgical population of the National Cancer Institute and its impact on postoperative outcomes.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Musallam 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.
- Goodnough LT, Shander A, Spivak JL, Waters JH, Friedman AJ, Carson JL, Keating EM, Maddox T, Spence R. Detection, evaluation, and management of anemia in the elective surgical patient. Anesth Analg. 2005 Dec;101(6):1858-1861. doi: 10.1213/01.ANE.0000184124.29397.EB.
- Sim YE, Abdullah HR. Implications of Anemia in the Elderly Undergoing Surgery. Clin Geriatr Med. 2019 Aug;35(3):391-405. doi: 10.1016/j.cger.2019.04.001. Epub 2019 May 27.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 15, 2025
Primary Completion (Estimated)
May 15, 2025
Study Completion (Estimated)
June 15, 2025
Study Registration Dates
First Submitted
April 7, 2025
First Submitted That Met QC Criteria
April 7, 2025
First Posted (Actual)
April 15, 2025
Study Record Updates
Last Update Posted (Actual)
April 15, 2025
Last Update Submitted That Met QC Criteria
April 7, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Instituto Nacional del Cáncer
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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