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ISRCTN
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ISRCTN87597684
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ClinicalTrials.gov identifier
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Public title
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Preoperative Acute Normovolaemic Haemodilution (ANH) in combination with Hypotensive Epidural Anaesthesia (HEA)
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Denmark
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Disease/condition/study domain
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Knee arthroplasty surgery
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Participants - inclusion criteria
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Patients scheduled for primary cemented Total Knee Replacement (TKR) surgery
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/2000
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Anticipated end date
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01/01/2001
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Status of trial
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Completed
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Patient information material
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Target number of participants
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28
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Interventions
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Patients were consecutive and blindly randomised to hypotensive epidural anaesthesia with or without acute normovolaemic haemodilution.
A mean of 877 ml blood was predonated (19.7% of the total blood volume). Blood loss was, except from the intraoperative loss, significantly higher in the ANH group. The total loss was 1306 mL (ANH) versus 1026 mL (non-ANH), P < 0.05. Except from the first hour postoperatively, haematocrit was identical in between groups postoperatively. The amount of blood transfusion was identical 386 ml (ANH) versus 343 ml (non-ANH) (NS). 50% went through surgery without receiving blood (ANH) versus 58% (non-ANH). No renal, neurological or cardiopulmonary complications were registered.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Not provided at time of registration
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=pubmed&dopt=AbstractPlus&list_uids=11960557
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Contact name
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Mr
Palle
Juelsgaard
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Address
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Department of Anaesthesia
Aarhus University Hospital
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City/town
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Aarhus Amtssygehus
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Zip/Postcode
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DK-8000
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Country
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Denmark
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Tel
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+45 89497575
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Fax
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+45 89497279
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Email
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Palle.Juelsgaard@aas.auh.dk
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Sponsor
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Aarhus University Hospital (Denmark)
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Address
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Department of Anaesthesia
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City/town
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Aarhus Amtssygehus
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Zip/Postcode
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DK-8000
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Country
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Denmark
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Date applied
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12/04/2002
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Last edited
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06/09/2007
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Date ISRCTN assigned
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12/04/2002
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