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Completed

NCT Number: NCT00906295

Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery

The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the postoperative ambulation.

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Key information

Conditions

Anemia Arthroplasty Hematologic Diseases Hemic and Lymphatic Diseases Hip Replacement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital, Copenhagen, Copenhagen NV, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • Patients undergoing replacement of hip arthroplasty
  • Be legally competent
  • Read and understand Danish

Exclusion criteria

  • Present malignant disease
  • Known heart disease with functionality equivalent to NYHA II or CCS II or worse

Treatment and study plan

Allowed drop in hemoglobin to 4.5-5.5 mmol/L

Other

Transfusion with red blood cells to hemoglobin between 4.5-5.5 mmol/L (Transfusion threshold of 4.5 mmol/L)

Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L

Other

Transfusion with red blood cells to between hemoglobin 5.6-6.5 mmol/L (Transfusion threshold of 5.5 mmol/L)

Primary outcomes

  1. Timed Up and Go-test (TUG)in seconds.

    Time frame: 30 days

    Timed Up and Go-test is performed when the patient is able to undertake the test after surgery. This is judged by a physiotherapist. The test measures how long it takes the patient to rise, walk 3 meters, turn around, walk back and sit down again.

Secondary outcomes

  1. The postoperative day patients can walk ten meters

    Time frame: 30 days

  2. Length of stay at hospital

    Time frame: 30 days

  3. The day the patient is able to perform Timed Up and Go-test

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • TrygFonden, Denmark

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 21, 2009
Registry last updated
Jun 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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