- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00199277
Iron Therapy in Colo-Rectal Neoplasm and Iron Deficiency Anemia: Intravenous Iron Sucrose Versus Oral Ferrous Sulphate.
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Zaragoza, Spain
- Hospital Miguel Servet
-
Contact:
- José Antonio García-Erce, MD
-
Principal Investigator:
- José Antonio García-Erce, MD
-
-
Barcelona
-
Badalona, Barcelona, Spain
- Hospital Universitari Germans Trias I Pujol
-
Contact:
- Marta Piñol Pascual, MD
-
Principal Investigator:
- Marta Piñol Pascual, MD
-
Calella, Barcelona, Spain
- Hospital Comarcal Sant Jaume de Calella.
-
Contact:
- Dolors Vela Payán, MD
-
Principal Investigator:
- Dolors Vela Payán, MD
-
Granollers, Barcelona, Spain
- Fundació Hospital Asil de Granollers
-
Contact:
- Ramón López Ferré, MD
-
Principal Investigator:
- Ramón López Ferré, MD
-
Mataró, Barcelona, Spain
- Consorci Sanitari del Maresme
-
Contact:
- Alba Bosch Llobet, MD
-
Principal Investigator:
- Alba Bosch Llobet, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Non-recurrent colorectal neoplasm, surgically resectable
- Anemia
Exclusion Criteria:
- Severe renal impairment
- High anesthetic risk
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Preoperative variations in hemoglobin.
|
Secondary Outcome Measures
Outcome Measure |
---|
Length of hospital stay
|
- Death
|
- Infections
|
Postoperative variations in hemoglobin.
|
Blood transfusion needs (pre, intra and postoperative)
|
Postoperative complications:
|
- Pulmonary thromboembolism
|
- Reintervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Pere Poch Martí, MD, Fundació Hospital-Asil de Granollers (Barcelona, Spain)
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Metabolic Diseases
- Neoplasms by Site
- Hematologic Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Nutrition Disorders
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Anemia, Hypochromic
- Iron Metabolism Disorders
- Malnutrition
- Neoplasms
- Colorectal Neoplasms
- Anemia, Iron-Deficiency
- Rectal Neoplasms
- Anemia
- Deficiency Diseases
- Physiological Effects of Drugs
- Trace Elements
- Micronutrients
- Hematinics
- Iron
- Ferric Oxide, Saccharated
Other Study ID Numbers
- DM01VEN/4/03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Neoplasm
-
Azienda Ospedaliera di PadovaIstituto Oncologico Veneto IRCCSRecruitingColorectal Adenocarcinoma | Colorectal Liver Metastases | Unresectable Malignant NeoplasmItaly
-
Carol Davila University of Medicine and PharmacyRecruitingNeoplasm, Colorectal | Neoplasm, Stomach | Neoplasm, Esophagus | Neoplasm, DuodenalRomania
-
Koen RoversHoffmann-La Roche; Comprehensive Cancer Centre The Netherlands; Dutch Cancer...RecruitingColorectal Cancer | Peritoneal Neoplasms | Colorectal Neoplasm | Peritoneal Carcinomatosis | Colorectal Carcinoma | Peritoneal Cancer | Peritoneal Metastases | Colorectal Adenocarcinoma | Colorectal Neoplasms Malignant | Peritoneal Neoplasm Malignant Secondary Carcinomatosis | Peritoneal Neoplasm Malignant...Netherlands, Belgium
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingMetastatic Malignant Neoplasm in the Liver | Advanced Malignant Neoplasm | Refractory Malignant Neoplasm | Colorectal Carcinoma Metastatic in the LiverUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Recurrent Colorectal Carcinoma | Metastatic Malignant Neoplasm in the Liver | Metastatic Colorectal Carcinoma | Metastatic Malignant Neoplasm in the Lung | Resectable Colorectal CarcinomaUnited States
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityUnknownColorectal Cancer | Neoplasm | Metastatic NeoplasmChina
-
Mayo ClinicRecruitingColorectal Cancer | Colorectal Liver MetastasesUnited States
-
Fundació Institut de Recerca de l'Hospital de la...UnknownColorectal Cancer | AngiogenesisSpain
-
TransgeneTerminatedColorectal Neoplasm | Digestive System NeoplasmFrance, Spain, Belgium
-
Bristol-Myers SquibbNovartisActive, not recruitingColorectal Cancer | Colorectal Neoplasm | Colorectal Tumors | Colorectal CarcinomaItaly, United States, Canada, Spain, Argentina, Australia, Belgium, Chile, Czechia, Germany
Clinical Trials on i.v. iron sucrose
-
Xinhua Hospital, Shanghai Jiao Tong University...Completed
-
Richard FedorakCompletedIron Deficiency | Inflammatory Bowel DiseaseCanada
-
HaEmek Medical Center, IsraelWithdrawn
-
University of OxfordNational Center of Cardiology and Internal Medicine named after academician...WithdrawnHypertension, PulmonaryKyrgyzstan
-
University of OxfordCompleted
-
Saskatchewan Health Authority - Regina AreaSaskatchewan Centre for Patient-Oriented ResearchRecruitingIron Deficiency Anaemia in ChildbirthCanada
-
Denver Health and Hospital AuthorityNational Trauma Research InstituteCompleted
-
Papageorgiou General HospitalCompletedAnemia in Chronic Renal DiseaseGreece
-
CN NGANOU-GNINDJIO, MD, MScCompletedIron Deficiency | Chronic Heart Failure (CHF)Cameroon
-
Leiden University Medical CenterRadboud University Medical Center; University Medical Center Groningen; Maastricht... and other collaboratorsRecruitingInflammatory Bowel Diseases | Iron-deficiency | Iron Deficiency AnemiaNetherlands