Intravenous iron versus packed cells in acute post-partum anemia

Category Primary study
Registry of TrialsANZCTR
Year 2015
INTERVENTION: Packed red blood cell transfusion (single or multiple units depending on starting Hb with target level of 9g/dL). Each packed cell transfusion (i.e. 1 unit) contains 260mL of red blood cells leukodepleted with 50g/unit of hemoglobin and a hematocrit of 0.59L/L. Each unit is administered over 4 hours as per routine hospital protocol. CONDITION: acute post partum anaemia acute post‐partum anemia following blood loss >1000mL PRIMARY OUTCOME: C Reactive Protein (serum assay) Ferritin (serum assay) Hemoglobin Level (serum assay) SECONDARY OUTCOME: Anemia symptom severity based on results of health related questionnaires designed to specifically evaluate symptoms of anemia (Euro‐QoL 5D; MFI 20 scales) Clinical evidence of infection following treatment (i.e. all or any of offensive vaginal discharge, wound discharge and dehiscence, cellulitis, mastitis and fever >38.5) Hemoglobin level (serum assay) Impact of anemia on breastfeeding quality using our own hospital designed Post Partum Symptom Score. We hope to validate the scale as part of the study. Reticulocyte count ; ; This outcome is measured by serum assay. Treatment safety (both IV iron and packed red cells) looking at incidence and severity of early adverse reactions including rash, bronchospasm, joint/muscle pain, headache, hypotension, tachycardia, syncope, circulatory collapse, chest pain, temperature, altered conscious state. Early adverse reactions monitored for by nursing staff as per hospital protocol at the time of administration. In the event of any adverse effects developing, nursing staff notify medical staff immediately for patient review. The medical officer than rates the reaction as mild/moderate or severe. Late adverse reactions typically include . urticaria, rash, mild non obstructive respiratory symptoms which are assessed via phone interview on Day 1 and 2 by a clinical midwife specialist. INCLUSION CRITERIA: Patients who sustain a primary post‐partum haemorrhage in excess of 500mL with a resultant Hb of 5.5‐8.0 g/dL within 24 hours of stabilisation and/or have a minimal haemoglobin drop of >3g/dL and are symptomatic (i.e. HR 100‐120, dizziness, increased respiratory rate to >/= 25 on minimal exertion or postural drop of BP >10mmHg) will be included.
Epistemonikos ID: c0fd39acd0c0170ccfc378b147558e45dfd393b6
First added on: Aug 23, 2024