Iron Therapy in Colo-Rectal Neoplasm and Iron Deficiency Anemia: Intravenous Iron Sucrose Versus Oral Ferrous Sulphate.

September 16, 2005 updated by: J. Uriach and Company

Randomized, Parallel Group, Clinical Trial Comparing Intravenous Iron Sucrose Versus Oral Ferrous Sulphate in the Treatment of Perioperative Iron Deficiency in Patients With Colo-Rectal Neoplasm and Iron Deficiency Anemia.

The main objective of this study is to evaluate the efficacy of intravenous iron sucrose in increasing preoperative haemoglobin values in patients with colo-rectal neoplasm and iron deficiency anemia, compared to the standard treatment with oral iron. It will also determine whether intravenous iron sucrose administration improves outcomes such as postoperative haemoglobin values, serum ferritin values, transfusional needs, postoperative complications, or length of hospital stay.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Most patients with colorectal neoplasm have iron deficiency, which can be triggered in the pre-operative period by a decrease of iron intake and the bleeding in the site of neoplasm.

In the postoperative period, iron deficiency can be aggravated by surgical bleeding.

Iron plays a leading rol in haemoglobin production, cell mitosis and immune system. Animal experimentation has shown that induced iron deficiency and mild anemia lead to postoperative mortality and lactacidemia in a model of peritonitis.

Moreover, anemia is the main risk factor to require intra and postoperative blood transfusions, and iron deficiency and anemia are associated to a larger number of postoperative complications (infections and longer hospital stay).

Oral iron therapy is the standard treatment in patients with preoperative iron deficiency, but iron levels inside red cells may not reach normality in time before surgery, and it can not be resumed until the patient can start again oral feeding.

In these patients, any increase in preoperative haemoglobin decreases the risk to need a blood transfusion during or after surgery.

This trial will compare standard oral iron and intravenous iron.

Study Type

Interventional

Enrollment

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Zaragoza, Spain
        • Hospital Miguel Servet
    • Barcelona
      • Badalona, Barcelona, Spain
        • Hospital Universitari Germans Trias I Pujol
      • Calella, Barcelona, Spain
        • Hospital Comarcal Sant Jaume de Calella.
      • Granollers, Barcelona, Spain
        • Fundació Hospital Asil de Granollers
      • Mataró, Barcelona, Spain
        • Consorci Sanitari Del Maresme

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-recurrent colorectal neoplasm, surgically resectable
  • Anemia

Exclusion Criteria:

  • Severe renal impairment
  • High anesthetic risk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Preoperative variations in hemoglobin.

Secondary Outcome Measures

Outcome Measure
Length of hospital stay
- Death
- Infections
Postoperative variations in hemoglobin.
Blood transfusion needs (pre, intra and postoperative)
Postoperative complications:
- Pulmonary thromboembolism
- Reintervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

J. Uriach and Company

Investigators

  • Study Chair: Pere Poch Martí, MD, Fundació Hospital-Asil de Granollers (Barcelona, Spain)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

September 20, 2005

Last Update Submitted That Met QC Criteria

September 16, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM01VEN/4/03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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