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Trial: NCT00998088 [RDF]

Label NCT00998088
Slug nct00998088
Trialid NCT00998088
Lookup name NCT00998088
Provenance http://clinicaltrials.gov/show/NCT00998088?displayxml=true
Lastchanged date October 19, 2009
Firstreceived results date
Firstreceived date October 19, 2009
Id info nct id NCT00998088
Overall status Completed
Id info secondary id ISRCTN96327523
Biospec retention
Required header link text Link to the current ClinicalTrials.gov record.
Enrollment 2598
Number of arms 6
Is section 801
Is fda regulated No
Brief title Blood Management in Orthopedic Surgery
Acronym TOMaat
Official title Optimal Blood Management in Elective Orthopaedic Surgery: The Transfusion "Op Maat" (TOMaat) Study
Study type Interventional
Id info nct alias
Completion date September 2009
Verification date October 2009
Why stopped
Id info org study id ISRCTN96327523
Required header url https://clinicaltrials.gov/show/NCT00998088
Study design Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Source Sanquin Research & Blood Bank Divisions
Primary completion date September 2009
Brief summary
Number of groups
Required header download date ClinicalTrials.gov processed this data on September 07, 2016
Phase Phase 4
Start date May 2004
Has expanded access No
Biospec descr
Detailed description Power/data analysis: In order to be able to detect a 75% reduction of allogeneic transfusions by Epo and a reduction of 30% by autologous (shed blood) transfusions (CS or D) with a power= 0.9 and an alpha= 0.05, inclusion of 2250 surgery patients (in a worst case scenario of high standard deviations) are required for intention-to-treat analysis. Knee surgery patients are not randomized for cell saver (no intra-operative blood loss).
Condition browse b1938f5b898b1b333bd4a4660edafd0f
Intervention browse 11b0d68660959ea7791c9cfc5c389354
Responsible party 8f370bd7a8e2569d2beafc3aa7e4a41b
Overall contact None
Overall contact backup None
Sponsor group 9c8c91fcb9aa0025ddea4c80d9f70b9a
Oversight info Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) (Oversight_info)
Eligibility f7a2cfd04fe92fef02f42a8bf6739f0f
Keywords adults, Blood management, elective, hip replacement, knee replacement, Orthopedic surgery, randomized study
Conditions Osteoarthritis
Locations 6521b8764fb54d266db88f85eb0cbe8f, 6576a3b161b9be3421a4c67890e394da, 9208dd9d3a4693b4f037c289501a450a, e26e094417aeda3c508511950f3a2362
Links None
Results references None
Arm groups drain (Arm Group), Erythropoietin and drain (Arm Group), Erythropoietin (Arm Group), Erythropoietin and cell saver (Arm Group), cell saver (Arm Group), Control arm (Arm Group)
Location countries Netherlands
Interventions None
Secondary outcomes 38160c127d01cb1b9b1caf7325bb9d29, 50ba9c4ff77a04588fbee39cb2bdb5aa, 6240dc063bc2a5d811f85d48159c8aff, 6e3db7c584d1fc7cca4d2bd8c2bcc607, cbfc03f064447dc179020779a928a5c3, e66be74e1f14764c9294ae0ed3278535, ef348fd7e0b3431352f27c0ff2f4edf1, f884903c26717757fe4e2cf6d291efe9
References None
Primary outcomes b67cbfcdc5ffb44784305e954668da61
Removed countries None
Overall officials 00048fff1eb093984f2f502975bae8e2