Trial | NCT01895205  Report issue

Title

Treatment of Women After Severe Postpartum Haemorrhage
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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    13
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
Study Started
Jun 30
2013
Primary Completion
Aug 31
2015
Study Completion
Aug 31
2015
Last Update
Aug 19
2015
Estimate

Drug Iron isomaltoside 1000

  • Other names: Monofer®

Drug Red blood cell transfusion

Iron isomaltoside 1000 Experimental

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.

Red blood cell transfusion Active Comparator

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

Criteria 

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
No Results Posted