Perioperative Management of Preoperative Anemia in Colorectal Cancer

Sponsor

Consorci Sanitari Integral (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06026618

Collaborator

(none)

1,294

Enrollment

Location

145

Anticipated Duration (Months)

8.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia Colorectal Cancer

Study Design

Study Type:

Observational

Actual Enrollment :

1294 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Jan 31, 2019

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
cohort 1 non-anemic patients (Hb > 13 g/dL)
cohort 2 mildly anemic patients (Hb 12-13 mg/dL) without criteria for IVI therapy
cohort 3 patients treated with IVI (Hb < 12mg/dL or Hb 12-13mg/dL with iron deficiency or risk factors for bleeding)

Outcome Measures

Primary Outcome Measures

Change in Hemoglobin [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 Outcome Measures

Total iron dose [up to 30 days]
Total iron dose administered from the first visit until surgery
number of days needed to complete treatment [up to 30 days]
days of treatment before surgery
number of complications related to IVI administration [up to 30 days]
number of complications related to IVI administration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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