The aim of this trial is to investigate which treatment option is superior in the treatment of anemia in patients undergoing surgery in terms of hemoglobin increase, postoperative morbidity, amount of bloodtransfusions needed, length of stay,…
ID
Source
Brief title
Condition
- Haematological disorders NEC
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of patients that will achieve normalization of HB-level.
(Normalization Hb: >7.5 mmol/L for women or >8.0 mmol/L for men.
Secondary outcome
- Change in morbidity score Comprehensive Complication Index.
- Change in baseline in other iron/hematological parameters (i.e. TSAT,
ferritin, CRP) at pre-operation, at day 1 and at 1, 4 and 8 weeks post-
operative.
- Time to achieve normalization of HB to minimum reference value.
- Change from baseline in health-related Quality of life.
- Change from baseline in fatigue scores.
- Amount of blood transfusions needed.
- Relation between anemia and Glasgow Prognostic Score (derived from CRP and
Albumine).
- Relation between CRP and degree of anemia.
- Gastro-intestinal intolerance of study drug treatment.
- Cost-effectiveness of intravenous iron treatment compared to oral.
Background summary
The incidence of colorectal cancer is increasing with an expected number of
14.000 patients in 2015. The implementation of screening programs is likely to
further increase this number. The colorectal carcinoma has a peak incidence in
the seventh decade of life and patients often present with comorbid iron
deficiency anemia. At least one third of patients with a colorectal carcinoma
that undergoes surgery are anemic preoperatively.
Anemia of patients with a colorectal carcinoma is partly caused by anal blood
loss, and is partly cancer-related. Cancer related anemia is multifactorial,
and is caused by impaired iron absorption and nutritional deficiency. Another
common cause is anemia of chronic disease, which is a cytokine-mediated
disorder. Tumor cells can produce proinflammatory cytokines which lead to a
functional iron deficiency.
Currently there are three options in the treatment of anemia: blood
transfusion, erythropoietin stimulating agents (ESA) and iron suppletion. Blood
transfusion and ESA are effective modalities in increasing hemoglobin levels,
however both modalities should be given with caution in oncologic patients as
they are associated with an increased risk of cancer recurrence and ESA is even
associated with an 17% increase in overall mortality in oncologic patients. The
last decades, with the implementation of enhanced recovery after surgery (ERAS)
programs, efficient patient care with accelerated recovery and shorter hospital
stay is becoming more and more important. Currently there is no standard of
care in the treatment of light to moderate anemia, some will have oral iron
prescribed others not.
A more profound treatment of iron deficiency anemia could play a crucial role
in optimizing patients conditions prior to surgery, as patients with iron
deficiency anemia suffer from fatigue and impaired physical performance, higher
morbidity and mortality
Study objective
The aim of this trial is to investigate which treatment option is superior in
the treatment of anemia in patients undergoing surgery in terms of hemoglobin
increase, postoperative morbidity, amount of bloodtransfusions needed, length
of stay, quality of life and fatigue scores.
Study design
Multicenter randomized trial
Intervention
Intravenous suppletion of Ferinject 20 ml (1000mg)
Study burden and risks
As there is no experimental arm there are no extra risks or burdens for the
patients other then already mentioned
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients with:
- Colorectal carcinoma
- Laparoscopic or open segment resection or a low anterior resection
- Iron deficiency anemia: Hb <7,5 for women and Hb <-8 mmol/ L for men en
TSAT<20%
- Age 18 years or older
-Written informed consent for study participation
Exclusion criteria
- Palliative surgery / metastasized disease
- Received blood transfusion within one month before screening
- Serum ferritine * 800 µg/L
- Pregnancy
- Preoperative chemoradiation (Short 5x5gy = no exclusion)
- Contraindication for the use of Ferinject or ferrofumarate
- ASA classification > 3
- Use of erythropoietin stimulating agents within three months before screening
- Chronic kidney disease (GFR < 30ml/min/m)
- Myelodysplastic syndrome
- Elevated liver enzymes
- Hereditary Heamochromatosis
- Thalassemia
- Hemolytic anemia/ chronic hemolysis
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-002827-87-NL |
| CCMO | NL50013.018.14 |