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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00199277
Other study ID # DM01VEN/4/03
Secondary ID
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
Est. completion date
Est. primary completion date
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


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
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