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Clinical Trials/NCT06026618
NCT06026618
Active, not recruiting
Not Applicable

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

Consorci Sanitari Integral1 site in 1 country1,294 target enrollmentJanuary 1, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anemia
Sponsor
Consorci Sanitari Integral
Enrollment
1294
Locations
1
Primary Endpoint
Change in Hemoglobin
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 1, 2012
End Date
January 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Hemoglobin

Time Frame: Baseline and up to 30 days

Change in serum hemoglobin concentration between baseline (at the moment of initial colorectal clinic visit) and day of surgery

Secondary Outcomes

  • Total iron dose(up to 30 days)
  • number of days needed to complete treatment(up to 30 days)
  • number of complications related to IVI administration(up to 30 days)

Study Sites (1)

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