AnemiaNCT06026618
Perioperative Management of Preoperative Anemia in Colorectal Cancer
An observational study of Anemia and Colorectal Cancer, run by Consorci Sanitari Integral at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Colorectal Cancer
- How many people
- 1,294 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2012to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients diagnosed with colorrectal cancer attended at the hospital
Who may be able to join
- Patients diagnosed with Colorectal Cancer
- Patients with an indication of elective radical surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Management of Preoperative Anemia in Colorectal Cancer. Effect of Intravenous Iron Treatment Within a Patient Blood Management on Colorectal Cancer Surgery
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.
- Conditions
- Anemia, Colorectal Cancer
- Keywords
- Anemia, Colorectal Cancer, Intravenous Iron Therapy, Transfusion, Patient Blood Management
- Medical subject headings
- Anemia, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin
Change in serum hemoglobin concentration between baseline (at the moment of initial colorectal clinic visit) and day of surgery
Measured: Baseline and up to 30 days
Secondary outcomes (3)
Total iron dose
Total iron dose administered from the first visit until surgery
Measured: up to 30 days
number of days needed to complete treatment
days of treatment before surgery
Measured: up to 30 days
number of complications related to IVI administration
number of complications related to IVI administration
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Jan 2012
- Primary completion31 Jan 2019
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari Integral
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026618
- Sponsor's protocol ID
- 21/19
- Status last verified
- Aug 2023
- First submitted
- 11 Jul 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Management of Preoperative Anemia in Colorectal Cancer. Effect of Intravenous Iron Treatment Within a Patient Blood Management on Colorectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT06026618
- Acronym / sponsor ID
- 21/19
- Conditions
- Anemia, Colorectal Cancer
- Keywords
- Anemia, Colorectal Cancer, Intravenous Iron Therapy, Transfusion, Patient Blood Management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,294 participants (actual)
- Lead sponsor
- Consorci Sanitari IntegralUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with colorrectal cancer attended at the hospital
Key inclusion criteria (2 listed)
- Patients diagnosed with Colorectal Cancer
- Patients with an indication of elective radical surgery
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Total iron dose
Time frame: up to 30 days
number of days needed to complete treatment
Time frame: up to 30 days
number of complications related to IVI administration
Time frame: up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Colorectal Cancer, run by Consorci Sanitari Integral at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin (time frame: Baseline and up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.