Clinical trial NCT06026618: Perioperative Management of Preoperative Anemia in Colorectal Cancer
Official title: Perioperative Management of Preoperative Anemia in Colorectal Cancer. Effect of Intravenous Iron Treatment Within a Patient Blood Management on Colorectal Cancer Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anemia
Colorectal Cancer
Keywords: Anemia
Colorectal Cancer
Intravenous Iron Therapy
Transfusion
Patient Blood Management
Lead sponsor: Consorci Sanitari Integral
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 1294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with colorrectal cancer attended at the hospital

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.


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

Primary outcomes:
measure: Change in Hemoglobin
timeFrame: Baseline and up to 30 days
Secondary outcomes:
measure: Total iron dose
timeFrame: up to 30 days
measure: number of days needed to complete treatment
timeFrame: up to 30 days
measure: number of complications related to IVI administration
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Sant Joan Despí
country: Spain
facility: Hospital de Sant Joan Despí, CSI
state: Barcelona
Study officials:
References: