Treatment of Women After Severe Postpartum Haemorrhage

Study Overview
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Brief Summary
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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

Official Title
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A Randomized Comparative, Open-Label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by High Single Dose In-fusions or Red Blood Cell Transfusion in Women With Severe Postpartum Iron Deficiency Anaemia

Conditions
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Severe Postpartum Haemorrhage

Intervention / Treatment
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* Drug: Iron isomaltoside 1000
* Drug: Red blood cell transfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PPH > 1000 mL Hb ≥ 5.5 and ≤ 8.0 g/dL (≥ 3.5 and ≤ 5.0 mmol/L) Willingness to participate and signed the informed consent form Exclusion Criteria: Women aged < 18 years Multiple births Peripartum RBC transfusion Known iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis) Known hypersensitivity to parenteral iron or any excipients in the investigational drug products Women with a history of active asthma within the last 5 years or a history of multiple allergies Known decompensated liver cirrhosis and active hepatitis Women with HELLP (Haemolysis Elevated Liver enzymes Low Platelet count) syndrome (defined according to Dansk Selskab for Obstetrik og Gynækologi guidelines) Active acute infection assessed by clinical judgement Rheumatoid arthritis with symptoms or signs of active joint inflammation History of anaemia caused by e. g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency) Not able to read, speak and understand the Danish language Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the baseline 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iron isomaltoside 1000<br>A single dose of 1500 mg iron isomaltoside 1000 is given. The dose is diluted in 100 ml 0.9% sodium chloride and given over approximately 15 min. | Drug: Iron isomaltoside 1000<br> <br> * Other names: Monofer®;|
| Active Comparator: Red blood cell transfusion<br>Allogenic RBC transfusion is dosed to trigger Hb: Women with Hb 5.5 - 6.4 g/dL (3.5-3.9 mmol/L) will receive 2 units of RBC Women with Hb 6.5 - 8.0 g/dL (4.0-5.0 mmol/L) will receive 1 unit of RBC | Drug: Red blood cell transfusion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Fatigue |  | From exposure to 12 weeks post-exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 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 | 
| 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 |