PRIVIRON: Intravenous Ferric Carboxymaltose (Ferinject) in Patients Undergoing Orthopaedic Surgery

• Sponsor: University Hospital Muenster (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01345968
• Collaborator: Vifor Pharma (Industry)
• Enrollment: 3
• Locations: 2
• Arms: 2
• Duration (Months): 20.1
• Patients Per Site: 1.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The primary purpose of this study is to evaluate the safety and efficacy of preoperative intravenous ferric carboxymaltose in patients with anemia undergoing hip or knee replacement

Condition or Disease	Intervention/Treatment	Phase
Anemia; Orthopedic Surgery; High Risk of Blood Loss	Drug: Ferinject 50 mg/ml; Drug: NaCl 0.9%	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Preoperative Intravenous Ferric Carboxymaltose (Ferinject) in Patients With Orthopedic Surgery and High Risk of Blood Loss
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: NaCl 0.9%	Drug: NaCl 0.9%; iv administration of max. 50 ml in 30 minutes
Experimental: Ferinject	Drug: Ferinject 50 mg/ml; iv administration of max. 50 ml (Dilution: 20 ml in 30 ml NaCl 0.9%) in 30 minutes

Outcome Measures

Primary Outcome Measures

1. Number of RBC units [Until postoperative day 7]

Secondary Outcome Measures

1. Blood transfusion rate [Until postoperative day 7]

   Number of patients with blood transfusions

2. Frequency of postoperative complications [Until postoperative day 7]

   Number of postoperative complications from baseline until postoperative day 7

3. Frequency of postoperative complications [Until 6 weeks after surgical intervention]

   Number of postoperative complication from baseline until 6 weeks after surgical intervention

4. Length of hospital stay [6 weeks after surgical intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age >= 18 years

• Patients scheduled to undergo hip or knee replacement

• 8 g/dl < Hb < 13 g/dl for men and 8 g/dl < Hb < 12 g/dl for women at screening (3-4 weeks prior to surgery)

• anemia

• signed written informed consent

Exclusion Criteria:

• immunosuppressive or myelosuppressive therapy

• history of thromboembolic events

• a concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient

• hypersensitivity to any component of the formulation

• transfusion within 1 month prior to study inclusion

• liver values 3 times higher than normal

• active severe infection/inflammation

• renal insufficiency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charité Universitätsmedizin Berlin	Berlin		Germany
2	University Hospital Muenster	Muenster		Germany	D-48149

Sponsors and Collaborators

• University Hospital Muenster
• Vifor Pharma

Investigators

• Principal Investigator: Hugo K Van Aken, PhD, MD, Department of Anesthesia and Intensiv Care, University Hospital Muenster

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital Muenster
• ClinicalTrials.gov Identifier: NCT01345968
• Other Study ID Numbers: UKM10_0027; 2010-024115-14; 05-AnIt-09
• First Posted: May 2, 2011
• Last Update Posted: Aug 9, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by University Hospital Muenster: anemia; transfusion; intravenous ferric carboxymaltose
• Additional relevant MeSH terms: Hemorrhage

Study Results

No Results Posted as of Aug 9, 2013