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

Iron Deficiency Anemia Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00199277
• Other study ID #: DM01VEN/4/03
• Status: Not yet recruiting
• Phase: Phase 4
• First received: September 16, 2005
• Last updated: September 16, 2005

Study information

• Verified date: September 2005
• Source: J. Uriach and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Non-recurrent colorectal neoplasm, surgically resectable

• Anemia

Exclusion Criteria:

• Severe renal impairment

• High anesthetic risk

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Colorectal Neoplasm
• Colorectal Neoplasms
• Deficiency Diseases
• Iron Deficiency Anemia
• Neoplasms
• Rectal Neoplasms

Intervention

Drug:
• i.v. iron sucrose

• Oral iron

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Comarcal Sant Jaume de Calella.	Calella	Barcelona
Spain	Fundació Hospital Asil de Granollers	Granollers	Barcelona
Spain	Consorci Sanitari del Maresme	Mataró	Barcelona
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
J. Uriach and Company

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative variations in hemoglobin.
Secondary	Postoperative variations in hemoglobin.
Secondary	Blood transfusion needs (pre, intra and postoperative)
Secondary	Postoperative complications:
Secondary	- Pulmonary thromboembolism
Secondary	- Infections
Secondary	- Reintervention
Secondary	- Death
Secondary	Length of hospital stay