Iron Therapy in Colo-Rectal Neoplasm and Iron Deficiency Anemia: Intravenous Iron Sucrose Versus Oral Ferrous Sulphate.
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Neoplasm Iron Deficiency Anemia |
Drug: i.v. iron sucrose Drug: Oral iron |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
- Preoperative variations in hemoglobin.
- Postoperative variations in hemoglobin.
- Blood transfusion needs (pre, intra and postoperative)
- Postoperative complications:
- - Pulmonary thromboembolism
- - Infections
- - Reintervention
- - Death
- Length of hospital stay
| Estimated Enrollment: | 150 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Non-recurrent colorectal neoplasm, surgically resectable
- Anemia
Exclusion Criteria:
- Severe renal impairment
- High anesthetic risk
Contacts and Locations| Spain | |
| Hospital Universitari Germans Trias i Pujol | Not yet recruiting |
| Badalona, Barcelona, Spain | |
| Contact: Marta Piñol Pascual, MD | |
| Principal Investigator: Marta Piñol Pascual, MD | |
| Hospital Comarcal Sant Jaume de Calella. | Not yet recruiting |
| Calella, Barcelona, Spain | |
| Contact: Dolors Vela Payán, MD | |
| Principal Investigator: Dolors Vela Payán, MD | |
| Fundació Hospital Asil de Granollers | Not yet recruiting |
| Granollers, Barcelona, Spain | |
| Contact: Ramón López Ferré, MD | |
| Principal Investigator: Ramón López Ferré, MD | |
| Consorci Sanitari del Maresme | Not yet recruiting |
| Mataró, Barcelona, Spain | |
| Contact: Alba Bosch Llobet, MD | |
| Principal Investigator: Alba Bosch Llobet, MD | |
| Hospital Miguel Servet | Not yet recruiting |
| Zaragoza, Spain | |
| Contact: José Antonio García-Erce, MD | |
| Principal Investigator: José Antonio García-Erce, MD | |
| Study Chair: | Pere Poch Martí, MD | Fundació Hospital-Asil de Granollers (Barcelona, Spain) |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00199277 History of Changes |
| Other Study ID Numbers: | DM01VEN/4/03 |
| Study First Received: | September 16, 2005 |
| Last Updated: | September 16, 2005 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Additional relevant MeSH terms:
|
Anemia, Iron-Deficiency Iron Metabolism Disorders Anemia Neoplasms Colorectal Neoplasms Rectal Neoplasms Deficiency Diseases Hematologic Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Intestinal Diseases Rectal Diseases Malnutrition Nutrition Disorders Anemia, Hypochromic Metabolic Diseases Ferric oxide, saccharated Ferric Compounds Iron Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions Trace Elements Micronutrients |
ClinicalTrials.gov processed this record on May 19, 2013