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Establishment of Optimal Transfusion Threshold During Spine Surgery

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ClinicalTrials.gov Identifier: NCT00967109
Recruitment Status : Completed
First Posted : August 27, 2009
Last Update Posted : February 25, 2011
Sponsor:
Collaborator:
TrygFonden, Denmark
Information provided by:
Rigshospitalet, Denmark

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

Condition or disease Intervention/treatment Phase
Anemia Spine Surgery Other: Allowed drop in hemoglobin to level between 4,5-5,6 mmol/L Other: Allowed drop in hemoglobin to level between 5,6-6,5 mmol/L Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Establishment of Optimal Transfusion Threshold During Spine Surgery
Study Start Date : September 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : February 2011

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U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Allowed drop in hemoglobin to 4,5-5,5 mmol/L
Transfusion with red blood cells to level between 4.5-5.5 mmol/L
Other: Allowed drop in hemoglobin to level between 4,5-5,6 mmol/L
Transfusion with red blood cells to hemoglobin level between 4,5-5,5 mmol/L
Experimental: Allowed drop in hemoglobin to 5,5-6,5 mmol/L
Transfusion with red blood cells to level between 5.5-6.5 mmol/L
Other: Allowed drop in hemoglobin to level between 5,6-6,5 mmol/L
Transfusion with red blood cells to hemoglobin level between 5,6-6,5 mmol/L



Primary Outcome Measures :
  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 Outcome Measures :
  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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967109


Locations
Denmark
Rigshospitalet
Copenhagen, Østerbro, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
TrygFonden, Denmark
Investigators
Principal Investigator: Kamilla Nielsen, MD Rigshospitalet, Denmark

Responsible Party: Kamilla Nielsen, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00967109     History of Changes
Other Study ID Numbers: H-C-2009-072
First Posted: August 27, 2009    Key Record Dates
Last Update Posted: February 25, 2011
Last Verified: February 2011

Keywords provided by Rigshospitalet, Denmark:
Anemia
Tissue oxygenation
Spine surgery