NCT00199277

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

5 active sites

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

First Submitted

Initial submission to the registry

September 16, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

September 20, 2005

Status Verified

September 1, 2005

First QC Date

September 16, 2005

Last Update Submit

September 16, 2005

Conditions

Colorectal NeoplasmIron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

  • Preoperative variations in hemoglobin.

Secondary Outcomes (8)

  • Postoperative variations in hemoglobin.

  • Blood transfusion needs (pre, intra and postoperative)

  • Postoperative complications:

  • - Pulmonary thromboembolism

  • - Infections

  • +3 more secondary outcomes

Interventions

i.v. iron sucroseDRUG
Oral ironDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-recurrent colorectal neoplasm, surgically resectable
  • Anemia

You may not qualify if:

  • Severe renal impairment
  • High anesthetic risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Location

Hospital Comarcal Sant Jaume de Calella.

Calella, Barcelona, Spain

Location

Fundació Hospital Asil de Granollers

Granollers, Barcelona, Spain

Location

Consorci Sanitari del Maresme

Mataró, Barcelona, Spain

Location

Hospital Miguel Servet

Zaragoza, Zaragoza, Spain

Location

MeSH Terms

Conditions

Colorectal NeoplasmsAnemia, Iron-Deficiency

Interventions

Iron

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Pere Poch Martí, MD

    Fundació Hospital-Asil de Granollers (Barcelona, Spain)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 20, 2005

Last Updated

September 20, 2005

Record last verified: 2005-09

Locations

ES(5)