Severe Postpartum Haemorrhage
Conditions
Brief summary
The primary purpose of this study is to get explorative information about IV high single dose infusion of iron isomaltoside 1000 compared to RBC transfusion in the treatment of severe PP-IDA evaluated as physical fatigue
Interventions
DRUGRed blood cell transfusion
Sponsors
BioStata
Pharmacosmos A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. PPH \> 1000 mL 2. Hb ≥ 5.5 and ≤ 8.0 g/dL (≥ 3.5 and ≤ 5.0 mmol/L) 3. Willingness to participate and signed the informed consent form
Exclusion criteria
1. Women aged \< 18 years 2. Multiple births 3. Peripartum RBC transfusion 4. Known iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis) 5. Known hypersensitivity to parenteral iron or any excipients in the investigational drug products 6. Women with a history of active asthma within the last 5 years or a history of multiple allergies 7. Known decompensated liver cirrhosis and active hepatitis 8. Women with HELLP (Haemolysis Elevated Liver enzymes Low Platelet count) syndrome (defined according to Dansk Selskab for Obstetrik og Gynækologi guidelines) 9. Active acute infection assessed by clinical judgement 10. Rheumatoid arthritis with symptoms or signs of active joint inflammation 11. History of anaemia caused by e. g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency) 12. Not able to read, speak and understand the Danish language 13. Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the baseline 14. Any other medical condition that, in the opinion of Investigator, may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study. For example, a malignancy, uncontrolled hypertension, unstable ischaemic heart disease or uncontrolled diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical Fatigue | From exposure to 12 weeks post-exposure |
Secondary
| Measure | Time frame |
|---|---|
| Change in Hb concentration | From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 |
| Change in p-ferritin | From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 |
| Fatigue symptoms | from baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 |
| Postpartum depression | From week 1 to 3, 8 and 12 |
| Breastfeeding | From exposure to 12 weeks post-exposure |
| Number of adverse drug reactions (ADRs) | From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 |
| Change in reticulocyte count | From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 |
| Change mean reticulocyte haemoglobin content (CHr) | From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 |
| Change in p-iron | From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 |
| Change in p-transferrin | From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 |
| Change in transferrin saturation (TSAT) | From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 |
Other
| Measure | Time frame |
|---|---|
| Change in anaemia symptoms | From Baseline to week 12 |
| Change in gastrointestinal symptoms | From Baseline to week 12 |
Countries
Denmark
Outcome results
None listed