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Trial record 36 of 36 for:    pharmacosmos

Intravenous Iron for Correction of Anaemia After Colorectal Surgery

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ClinicalTrials.gov Identifier: NCT02999217
Recruitment Status : Unknown
Verified December 2016 by Kaunas University of Medicine.
Recruitment status was:  Recruiting
First Posted : December 21, 2016
Last Update Posted : December 21, 2016
Sponsor:
Collaborators:
Orivas, Lithuania
Pharmacosmos A/S
Information provided by (Responsible Party):
Kaunas University of Medicine

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.


Condition or disease Intervention/treatment Phase
Anemia, Iron-Deficiency Intravenous Drug Usage Colorectal Neoplasms Colorectal Surgery Drug: Iron isomaltoside Drug: Saline Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of Treatment of Anaemia With Intravenous Iron on Haematological Values for Patients After Colorectal Surgery
Study Start Date : October 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Active Comparator: Treatment
1 g of intravenous iron isomaltoside given postoperatively for patients with preoperative anaemia (Hb 90-120 g/l and plasma ferritin<100 mkg/l).
Drug: Iron isomaltoside

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.

Other Name: Monofer

Placebo Comparator: Control
The same amount of intravenous saline for patients with preoperative anaemia (Hb 90-120 g/l and plasma ferritin<100 mkg/l).
Drug: Saline

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.

Other Name: Sodium chloride




Primary Outcome Measures :
  1. Changes in haemoglobin level [ Time Frame: 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 Outcome Measures :
  1. Changes of plasma ferritin [ Time Frame: 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

  2. Changes of red blood cell count [ Time Frame: 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

  3. Changes of mean corpuscular volume [ Time Frame: 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

  4. Changes of mean corpuscular haemoglobin concentration [ Time Frame: 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

  5. Changes of reticulocyte count [ Time Frame: 4 weeks after surgery ]
    It will be tested in both groups at the day of discharge and 4 weeks after surgery

  6. Changes of reticulocyte haemoglobin count [ Time Frame: 4 weeks after surgery ]
    It will be tested in both groups at the day of discharge and 4 weeks after surgery

  7. Rate of blood transfusion [ Time Frame: 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.

  8. Amount of intravenous fluid therapy [ Time Frame: 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.

  9. Number of participants with perioperative complications [ Time Frame: 4 weeks after surgery ]
    Total number of postoperative complications will be counted in both groups.

  10. Duration of hospital stay [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999217


Contacts
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Contact: Jurate Gudaityte, MDPhDAssProf +37069808531 jurate.gudaityte@kaunoklinikos.lt
Contact: Andrius Macas, MDPhDProf +37068639123 andrius.macas@kaunoklinikos.lt

Locations
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Lithuania
Department of Anaesthesiology, Lithuanian University of Health Sciences Recruiting
Kaunas, Lithuania, LT50009
Contact: Jurate Gudaityte, MDPhDAssProf    +37069808531    jurate.gudaityte@kaunoklinikos.lt   
Contact: Andrius Macas, MDPhDProf    +37068639123    andrius.macas@kaunoklinikos.lt   
Sub-Investigator: Ruta Paskauskaite, student         
Sponsors and Collaborators
Kaunas University of Medicine
Orivas, Lithuania
Pharmacosmos A/S
Investigators
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Study Chair: Andrius Macas, MDPhDProf Head of the Department of Anaesthesiology, Medical academy, Lithuanian University of Health Sciences

Publications:

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Responsible Party: Kaunas University of Medicine
ClinicalTrials.gov Identifier: NCT02999217     History of Changes
Other Study ID Numbers: BEC-MF-74
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion.

Keywords provided by Kaunas University of Medicine:
iron isomaltoside
plasma ferritin
haemoglobin
colorectal cancer

Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Colorectal Neoplasms
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs