Perioperative Management of Preoperative Anemia in Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Perioperative Management of Preoperative Anemia in Colorectal Cancer. Effect of Intravenous Iron Treatment Within a Patient Blood Management on Colorectal Cancer Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06026618
• Other study ID #: 21/19
• Status: Active, not recruiting
• Start date: January 1, 2012
• Est. completion date: January 31, 2024

Study information

• Verified date: August 2023
• Source: Consorci Sanitari Integral
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Both preoperative anemia (PA) and perioperative blood transfusion can contribute on poorer outcomes after colon cancer surgery. Anemia is known to be associated with a slower recovery after surgery thus often worsening short-term results, and allogenic red blood cells transfusion (ARBT) are known to promote systemic inflammatory response and affect overall and cancer-specific survival.

Patient Blood Management (PBM) systems are an evidence-based multimodal approach focused on safe and rational use of blood products, mainly through a proper PA assessment, a minimization of procedural blood loos and strict transfusion policies. Given the high prevalence of PA in patients with colorectal cancer (CRC), and its association with adverse events, it is expected that PBM implementation in said scenario carries a decrease in complications and an improved survival rate. Available literature to date supports preoperative anaemia screening and restrictive transfusion policies, nevertheless barriers exist that limit the expected implementation of PBM systems in colorectal surgery.

The present study aims to evaluate feasibility of a PBM pathway implementation in a high-volume CRC Surgery Unit based on completion of anemia screening and treatment before surgery and changes of allogenic products use along the years. The objective is to estimate the impact of a proper preoperative optimization with iron intravenous infusion (IVI) on PA measured from changes Hemoglobin (Hb) levels in comparison to those of non-anemic patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1294
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with Colorectal Cancer

• Patients with an indication of elective radical surgery

Exclusion Criteria:

• treatment with red blood cells transfusion before assessment in the PBM Anemia Clinic

• non-iron deficient anemia

• treatment with Sucrose-based IVI or Oral Iron (OI) preparations not strictly controlled by the PBM clinic

Related Conditions & MeSH terms

• Anemia
• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Spain	Hospital de Sant Joan Despí, CSI	Sant Joan Despí	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari Integral

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin	Change in serum hemoglobin concentration between baseline (at the moment of initial colorectal clinic visit) and day of surgery	Baseline and up to 30 days
Secondary	Total iron dose	Total iron dose administered from the first visit until surgery	up to 30 days
Secondary	number of days needed to complete treatment	days of treatment before surgery	up to 30 days
Secondary	number of complications related to IVI administration	number of complications related to IVI administration	up to 30 days