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Establishment of Optimal Transfusion Threshold During Spine Surgery

This study has been completed.
Sponsor:
Collaborator:
TrygFonden, Denmark
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00967109
First received: August 24, 2009
Last updated: February 24, 2011
Last verified: February 2011
History of Changes
  Purpose

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


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Establishment of Optimal Transfusion Threshold During Spine Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • The change in subcutaneous oxygen tension from incision. [ Time Frame: Every fifteen minutes throughout surgery ] [ Designated as safety issue: No ]
    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:
  • Oxygenation of the brain [ Time Frame: Every fifteen minutes throughout surgery ] [ Designated as safety issue: Yes ]
  • The concentration of lactate in plasma [ Time Frame: Every half an hour throughout surgery ] [ Designated as safety issue: Yes ]
  • Variation in the ST-segment of the ECG [ Time Frame: Every fifteen minutes throughout surgery ] [ Designated as safety issue: Yes ]
  • Muscular saturation of the deltoid muscle [ Time Frame: Every fifteen minutes throughout surgery ] [ Designated as safety issue: No ]
    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.

  • The change in subcutaneous oxygen tension from incision. [ Time Frame: Every fifteen minutes throughout surgery ] [ Designated as safety issue: No ]
    The lowest measured subcutaneous oxygen tension and the last measured subcutaneous oxygen tension throughout surgery.


Estimated Enrollment: 60
Study Start Date: September 2009
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00967109

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

No publications provided

Responsible Party: Kamilla Nielsen, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00967109     History of Changes
Other Study ID Numbers: H-C-2009-072
Study First Received: August 24, 2009
Last Updated: February 24, 2011
Health Authority: Denmark: Ethics Committee

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

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013