Status:
COMPLETED
Comparing Intravenous and Oral Iron in Postoperative Anemia
Lead Sponsor:
Parc de Salut Mar
Collaborating Sponsors:
Vifor Pharma
Conditions:
Postoperative Anemia
Osteoarthritis, Knee
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Postoperative anaemia are common in patients undergoing major orthopaedic surgery. The main consequence of perioperative anaemia is an increased risk of red blood cell (RBC) transfusions. Allogeneic R...
Detailed Description
Both pre- and postoperative anaemia are common in patients undergoing major orthopaedic surgery. The main consequence of perioperative anaemia is an increased risk of red blood cell (RBC) transfusions...
Eligibility Criteria
Inclusion
- Adult patients (≥18 years of age) were recruited at the scheduled preoperative visit (21 to 30 days prior surgery knee replacement). Anaemia (Hb \<12 g/dL) and/or iron deficiency (TSAT \<20%) the day after surgery
Exclusion
- Patients with known hypersensitivity or contraindications to iron, liver insufficiency (aspartate aminotransferase or alanine aminotransferase \>60 IU/L), bronchial asthma, presence of acute or chronic infection, severe heart disease, significant history of allergies (rash, etc.) or anti-anaemia treatment within 15 days prior to surgery were excluded from participation. Also pregnant or nursing women were excluded (negative pregnancy urine test within 7 days prior first study treatment or amenorrhoea for at least 12 months).
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT01913808
Start Date
January 1 2011
End Date
January 1 2013
Last Update
April 6 2016
Active Locations (1)
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1
Hospital de la Esperanza (Parc de Salut MAR)
Barcelona, Barcelona, Spain, 08024