Condition category
Musculoskeletal Diseases
Date applied
12/04/2002
Date assigned
12/04/2002
Last edited
06/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Palle Juelsgaard

ORCID ID

Contact details

Department of Anaesthesia
Aarhus University Hospital
Aarhus Amtssygehus
DK-8000
Denmark
+45 89497575
Palle.Juelsgaard@aas.auh.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Knee arthroplasty surgery

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2000

Overall trial end date

01/01/2001

Reason abandoned

Eligibility

Participant inclusion criteria

Patients scheduled for primary cemented Total Knee Replacement (TKR) surgery

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

28

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2000

Recruitment end date

01/01/2001

Locations

Countries of recruitment

Denmark

Trial participating centre

Department of Anaesthesia
Aarhus Amtssygehus
DK-8000
Denmark

Sponsor information

Organisation

Aarhus University Hospital (Denmark)

Sponsor details

Department of Anaesthesia
Aarhus Amtssygehus
DK-8000
Denmark

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=pubmed&dopt=AbstractPlus&list_uids=11960557

Publication citations

  1. Results

    Juelsgaard P, Møller M, Larsen U, Preoperative Acute Normovolaemic Hemodilution (ANH) in combination with Hypotensive Epidural Anaesthesia (HEA) during knee arthroplasty surgery. No effect on transfusion rate. A randomized controlled trial [ISRCTN87597684]., BMC Anesthesiol, 2002, 2, 1, 1.

Additional files

Editorial Notes