NCT06026618

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,294

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

September 7, 2023

Status Verified

August 1, 2023

Enrollment Period

7.1 years

First QC Date

July 11, 2023

Last Update Submit

September 4, 2023

Conditions

AnemiaColorectal Cancer

Keywords

AnemiaColorectal CancerIntravenous Iron TherapyTransfusionPatient Blood Management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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 Arms (3)

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)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with colorrectal cancer attended at the hospital

You may qualify if:

  • Patients diagnosed with Colorectal Cancer
  • Patients with an indication of elective radical surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Sant Joan Despí, CSI

Sant Joan Despí, Barcelona, 08970, Spain

Location

MeSH Terms

Conditions

AnemiaColorectal Neoplasms

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2023

First Posted

September 7, 2023

Study Start

January 1, 2012

Primary Completion

January 31, 2019

Study Completion

January 31, 2024

Last Updated

September 7, 2023

Record last verified: 2023-08

Locations

ES(1)