Treatment of Women After Severe Postpartum Haemorrhage
Phase 3
Completed
- Conditions
- Severe Postpartum Haemorrhage
- Interventions
- Drug: Red blood cell transfusion
- Registration Number
- NCT01895205
- Lead Sponsor
- Pharmacosmos A/S
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 13
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Red blood cell transfusion Red blood cell transfusion 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 Iron isomaltoside 1000 Iron isomaltoside 1000 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.
- Primary Outcome Measures
Name Time Method Physical Fatigue From exposure to 12 weeks post-exposure
- Secondary Outcome Measures
Name Time Method Change in Hb concentration From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 Number of adverse drug reactions (ADRs) 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 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-ferritin 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 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