Back to resultsIron Therapy in Colo-Rectal Neoplasm and Iron Deficiency Anemia: Intravenous Iron Sucrose Versus Oral Ferrous Sulphate.
Primary Purpose
Colorectal Neoplasm, Iron Deficiency Anemia
Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
i.v. iron sucrose
Oral iron
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasm
Eligibility Criteria
Inclusion Criteria: Non-recurrent colorectal neoplasm, surgically resectable Anemia Exclusion Criteria: Severe renal impairment High anesthetic risk
Sites / Locations
- Hospital Universitari Germans Trias i Pujol
- Hospital Comarcal Sant Jaume de Calella.
- Fundació Hospital Asil de Granollers
- Consorci Sanitari del Maresme
- Hospital Miguel Servet
Outcomes
Primary Outcome Measures
Preoperative variations in hemoglobin.
Secondary Outcome Measures
Postoperative variations in hemoglobin.
Blood transfusion needs (pre, intra and postoperative)
Postoperative complications:
- Pulmonary thromboembolism
- Infections
- Reintervention
- Death
Length of hospital stay
Full Information
NCT ID
NCT00199277
First Posted
September 16, 2005
Last Updated
September 16, 2005
Sponsor
J. Uriach and Company
1. Study Identification
Unique Protocol Identification Number
NCT00199277
Brief Title
Iron Therapy in Colo-Rectal Neoplasm and Iron Deficiency Anemia: Intravenous Iron Sucrose Versus Oral Ferrous Sulphate.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
J. Uriach and Company
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasm, Iron Deficiency Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
i.v. iron sucrose
Intervention Type
Drug
Intervention Name(s)
Oral iron
Primary Outcome Measure Information:
Title
Preoperative variations in hemoglobin.
Secondary Outcome Measure Information:
Title
Postoperative variations in hemoglobin.
Title
Blood transfusion needs (pre, intra and postoperative)
Title
Postoperative complications:
Title
- Pulmonary thromboembolism
Title
- Infections
Title
- Reintervention
Title
- Death
Title
Length of hospital stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-recurrent colorectal neoplasm, surgically resectable
Anemia
Exclusion Criteria:
Severe renal impairment
High anesthetic risk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pere Poch Martí, MD
Organizational Affiliation
Fundació Hospital-Asil de Granollers (Barcelona, Spain)
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Piñol Pascual, MD
First Name & Middle Initial & Last Name & Degree
Marta Piñol Pascual, MD
Facility Name
Hospital Comarcal Sant Jaume de Calella.
City
Calella
State/Province
Barcelona
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dolors Vela Payán, MD
First Name & Middle Initial & Last Name & Degree
Dolors Vela Payán, MD
Facility Name
Fundació Hospital Asil de Granollers
City
Granollers
State/Province
Barcelona
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramón López Ferré, MD
First Name & Middle Initial & Last Name & Degree
Ramón López Ferré, MD
Facility Name
Consorci Sanitari del Maresme
City
Mataró
State/Province
Barcelona
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alba Bosch Llobet, MD
First Name & Middle Initial & Last Name & Degree
Alba Bosch Llobet, MD
Facility Name
Hospital Miguel Servet
City
Zaragoza
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Antonio García-Erce, MD
First Name & Middle Initial & Last Name & Degree
José Antonio García-Erce, MD
12. IPD Sharing Statement
Learn more about this trial
Iron Therapy in Colo-Rectal Neoplasm and Iron Deficiency Anemia: Intravenous Iron Sucrose Versus Oral Ferrous Sulphate.
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