Colorectal NeoplasmPhase 4NCT00199277
Iron Therapy in Colo-Rectal Neoplasm and Iron Deficiency Anemia: Intravenous Iron Sucrose Versus Oral Ferrous Sulphate.
A Phase 4 study testing i.v. iron sucrose and Oral iron in people with Colorectal Neoplasm and Iron Deficiency Anemia, run by J. Uriach and Company at 5 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasm, Iron Deficiency Anemia
- What is being tested?
- i.v. iron sucrose and Oral iron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 150 participants
- Where
- 5 sitesSpain
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-recurrent colorectal neoplasm, surgically resectable
- Anemia
Who cannot join
- Severe renal impairment
- High anesthetic risk
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona
Marta Piñol Pascual, MD
Marta Piñol Pascual, MD
Hospital Comarcal Sant Jaume de Calella.
Calella, Barcelona
Dolors Vela Payán, MD
Dolors Vela Payán, MD
Fundació Hospital Asil de Granollers
Granollers, Barcelona
Ramón López Ferré, MD
Ramón López Ferré, MD
Consorci Sanitari del Maresme
Mataró, Barcelona
Alba Bosch Llobet, MD
Alba Bosch Llobet, MD
Hospital Miguel Servet
Zaragoza, Zaragoza
José Antonio García-Erce, MD
José Antonio García-Erce, MD
About this study
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.
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.
Read the 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.
- Conditions
- Colorectal Neoplasm, Iron Deficiency Anemia
- Being tested
- i.v. iron sucrose, Oral iron
- Medical subject headings
- Colorectal Neoplasms, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i.v. iron sucroseDrug
Oral ironDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative variations in hemoglobin.
Secondary outcomes (8)
Postoperative variations in hemoglobin.
Blood transfusion needs (pre, intra and postoperative)
Postoperative complications:
- Pulmonary thromboembolism
- Infections
- Reintervention
- Death
Length of hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- J. Uriach and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pere Poch Martí, MD, Study chair, Fundació Hospital-Asil de Granollers (Barcelona, Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199277
- Sponsor's protocol ID
- DM01VEN/4/03
- Status last verified
- Sep 2005
- First submitted
- 16 Sep 2005
- Last updated
- 20 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00199277
- Acronym / sponsor ID
- DM01VEN/4/03
- Conditions
- Colorectal Neoplasm, Iron Deficiency Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants
- Lead sponsor
- J. Uriach and CompanyIndustry (pharma, biotech, devices)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non-recurrent colorectal neoplasm, surgically resectable
- Anemia
Key exclusion criteria (2 listed)
- Severe renal impairment
- High anesthetic risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| i.v. iron sucrose | Drug | – |
| Oral iron | Drug | – |
Primary outcome
Preoperative variations in hemoglobin.
8 secondary outcomes
Postoperative variations in hemoglobin.
Blood transfusion needs (pre, intra and postoperative)
Postoperative complications:
- Pulmonary thromboembolism
- Infections
- Reintervention
- Death
Length of hospital stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pere Poch Martí, MD study chair
Fundació Hospital-Asil de Granollers (Barcelona, Spain)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing i.v. iron sucrose and Oral iron in people with Colorectal Neoplasm and Iron Deficiency Anemia, run by J. Uriach and Company at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative variations in hemoglobin.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2005.