Anemia, Iron-Deficiency, Intravenous Drug Usage, Colorectal Neoplasms, Colorectal Surgery
Conditions
Keywords
iron isomaltoside, plasma ferritin, haemoglobin, colorectal cancer
Brief summary
This 4-week prospective double blind anaemia management study evaluates the effect of high-dose postoperative intravenous iron vs placebo for patients after colorectal cancer surgery. Patients with preoperative levels of haemoglobin 90-120 g/l will be randomly assigned to receive either 1 g of intravenous iron or equal amount of saline postoperatively. Comparison will be based on the levels of haemoglobin, ferritin and other haematological parameters over time and profile of clinical recovery. The primary end point is that iron isomaltoside given postoperatively is superior to placebo in terms of increase and stability of levels of haemoglobin and other haematological parameters.
Detailed description
The Aim: to assess the effect of treatment of preoperative anaemia with intravenous iron on haematological parameters for patients after elective colorectal surgery. Primary Hypothesis: postoperative treatment with intravenous iron increases the levels of haemoglobin, ferritin, red cell count and is superior compared to placebo. Secondary effects: treatment with intravenous iron vs placebo provides reduction of blood transfusions, postoperative complications and hospital stay. The Objectives: 1. To estimate the rate of preoperative anaemia in patients of elective colorectal surgery. 2. To assess the dynamic changes of total blood count values in colorectal surgery patients treated with postoperative intravenous iron. 3. To compare the changes in total blood count values over time in colorectal surgery patients treated with intravenous iron versus colorectal surgery patients of the control group. Methods: The prospective, double-blinded study includes American Society of Anaesthesiology (ASA) I-III patients, aged 18-75 years, admitted for elective colorectal surgery. Preoperatively, patients with levels of haemoglobin 90-120 g/l will be identified and their serum ferritin will be tested. In cases of ferritin\<100 mkg/l, patients will be blindly randomized into one of the two groups: treatment group (group T) is given 1000 mg of intravenous iron (iron isomaltoside, Orivas, Pharmacosmos) in the postoperative recovery ward and control group (group C) which is given the same volume of intravenous saline (placebo). Patients in both groups will be provided with general anaesthesia (fentanyl, propofol, atracurium, inhaled sevoflurane for maintenance) and after tracheal extubation will be transferred to the recovery ward. Patient blood tests: total blood count, haemoglobin, haematocrit, mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), plasma ferritin) will be assessed in both groups 1 day preoperatively, day 1 and 3 postoperatively, the day of discharge and 4 weeks after discharge from the department of surgery. The level of reticulocyte and reticulocyte haemoglobin concentration will be determined on the day of discharge and 4 weeks after discharge. According to the study protocol, groups will also be compared in terms of clinical recovery, requirements of intravenous fluids and blood transfusion and duration of hospital stay.
Interventions
Intravenous injection 1 g given postoperatively in the recovery ward. Blood tests including red blood cell count, plasma ferritin, haemoglobin, haematocrit, mean corpuscular volume, mean haemoglobin concentration are made 1 day preoperatively, day 1, day 3 postoperatively, day of discharge and 1 month after discharge. Reticulocyte count and reticulocyte haemoglobin concentration tests are made on the day of discharge and 1 month after discharge. Count of total consumption of intravenous blood products. Count of total intravenous fluids. Clinical recovery and complications. Duration of hospital stay.
DRUGSaline
Intravenous injection given postoperatively in the recovery ward. Blood tests including red blood cell count, plasma ferritin, haemoglobin, haematocrit, mean corpuscular volume, mean haemoglobin concentration are made 1 day preoperatively, day 1, day 3 postoperatively, day of discharge and 1 month after discharge. Reticulocyte count and reticulocyte haemoglobin concentration tests are made on the day of discharge and 1 month after discharge. Count of total consumption of intravenous blood products. Count of total intravenous fluids. Clinical recovery and complications. Duration of hospital stay.
Sponsors
Orivas, Lithuania
Pharmacosmos A/S
Kaunas University of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* elective colorectal cancer surgery * preoperative haemoglobin 90-120 g/l * preoperative plasma ferritin \<100 mkg/l
Exclusion criteria
* laparoscopic colorectal surgery * body mass \<50kg * history of overdosage of iron products * family history of haemochromatosis, thalassaemia, * non-iron deficiency anaemia (Vit. B12, folic acid defficiency, haemoglobinopathies) * under treatment with erythropoietin, intravenous iron or blood transfusion in the last 12 weeks * allergy to iron carboxymaltose or its supplements * body temperature \> 37.5 °C or under antibiotic use * chronic liver diseases or/and increased levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times over normal upper limit * patients ill with grave bronchial asthma * patients with manifestation of allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in haemoglobin level | 4 weeks after surgery | Haemoglobin level will be tested in both groups at day 1, 3 postoperatively, day of discharge and 4 weeks after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of red blood cell count | 4 weeks after surgery | Other haematological variables will be tested in both groups at day 1, 3 postoperatively, day of discharge and 4 weeks after surgery |
| Changes of mean corpuscular volume | 4 weeks after surgery | Other haematological variables will be tested in both groups at day 1, 3 postoperatively, day of discharge and 4 weeks after surgery |
| Changes of mean corpuscular haemoglobin concentration | 4 weeks after surgery | Other haematological variables will be tested in both groups at day 1, 3 postoperatively, day of discharge and 4 weeks after surgery |
| Changes of reticulocyte count | 4 weeks after surgery | It will be tested in both groups at the day of discharge and 4 weeks after surgery |
| Changes of plasma ferritin | 4 weeks after surgery | Other haematological variables will be tested in both groups at day 1, 3 postoperatively, day of discharge and 4 weeks after surgery |
| Rate of blood transfusion | From date of randomization until the day of discharge from the hospital, up to 2 weeks after surgery | Total amount of blood transfusion units will be counted 2 weeks after surgery in both groups. |
| Amount of intravenous fluid therapy | From date of randomization until the day of discharge, up to 2 weeks after surgery | Total amount of intravenous fluids will be counted starting from the date of randomization, separately in the operating room, recovery area and each day postoperatively until 2 weeks after surgery in both groups. |
| Number of participants with perioperative complications | 4 weeks after surgery | Total number of postoperative complications will be counted in both groups. |
| Duration of hospital stay | From the date of randomization until the day of discharge, up to 2 weeks after surgery | It will be counted in both groups 2 weeks after surgery in both groups. |
| Changes of reticulocyte haemoglobin count | 4 weeks after surgery | It will be tested in both groups at the day of discharge and 4 weeks after surgery |
Countries
Lithuania
Contacts
Primary ContactJurate Gudaityte, MDPhDAssProf
Backup ContactAndrius Macas, MDPhDProf
Outcome results
None listed