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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by J. Uriach and Company.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
J. Uriach and Company
ClinicalTrials.gov Identifier:
NCT00199277
First received: September 16, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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.

Resource links provided by NLM:


Further study details as provided by J. Uriach and Company:

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

Estimated Enrollment: 150
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-recurrent colorectal neoplasm, surgically resectable
  • Anemia

Exclusion Criteria:

  • Severe renal impairment
  • High anesthetic risk
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199277

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         
Sponsors and Collaborators
J. Uriach and Company
Investigators
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
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
Iron Metabolism Disorders
Metabolic Diseases
Ferric oxide, saccharated
Ferric Compounds
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients

ClinicalTrials.gov processed this record on July 23, 2014