Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199277
Status:
UNKNOWN
Last Update Posted:
2005-09-20
First Post:
2005-09-16
Brief Title:
Iron Therapy in Colo-Rectal Neoplasm and Iron Deficiency Anemia Intravenous Iron Sucrose Versus Oral Ferrous Sulphate
Sponsor:
J Uriach and Company
Organization:
J Uriach and Company
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None