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Completed

NCT Number: NCT00967109

Establishment of Optimal Transfusion Threshold During Spine Surgery

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

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases Spine Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, Østerbro, 2100, Denmark

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 spine surgery
  • Be legally competent
  • Read and understand Danish

Exclusion criteria

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

Treatment and study plan

Allowed drop in hemoglobin to level between 4,5-5,6 mmol/L

Other

Transfusion with red blood cells to hemoglobin level between 4,5-5,5 mmol/L

Allowed drop in hemoglobin to level between 5,6-6,5 mmol/L

Other

Transfusion with red blood cells to hemoglobin level between 5,6-6,5 mmol/L

Primary outcomes

  1. The change in subcutaneous oxygen tension from incision.

    Time frame: Every fifteen minutes throughout surgery

    The primary endpoint is the change in subcutaneous oxygen tension from incision until the time most patients is still undergoing surgery. Subcutaneous oxygen tension is measured every fifteen minutes throughout surgery. The oxygen tension is measured with a polygraphic electrode (Clark's electrode).

Secondary outcomes

  1. Oxygenation of the brain

    Time frame: Every fifteen minutes throughout surgery

  2. The concentration of lactate in plasma

    Time frame: Every half an hour throughout surgery

  3. Variation in the ST-segment of the ECG

    Time frame: Every fifteen minutes throughout surgery

  4. Muscular saturation of the deltoid muscle

    Time frame: Every fifteen minutes throughout surgery

    The change in muscular saturation from incision until the time when most patientes are still undergoing surgery. Furthermore the lowest measured and the last measured muscular saturation is also evaluated.

  5. The change in subcutaneous oxygen tension from incision.

    Time frame: Every fifteen minutes throughout surgery

    The lowest measured subcutaneous oxygen tension and the last measured subcutaneous oxygen tension throughout surgery.

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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
Aug 27, 2009
Registry last updated
Feb 25, 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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