- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00967109
Establishment of Optimal Transfusion Threshold During Spine Surgery
February 24, 2011 updated by: Rigshospitalet, Denmark
The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the tissue oxygenation.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Østerbro
-
Copenhagen, Østerbro, Denmark, 2100
- Rigshospitalet
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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
|
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
|
Transfusion with red blood cells to hemoglobin level between 5,6-6,5 mmol/L
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Every fifteen minutes throughout surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxygenation of the brain
Time Frame: Every fifteen minutes throughout surgery
|
Every fifteen minutes throughout surgery
|
|
The concentration of lactate in plasma
Time Frame: Every half an hour throughout surgery
|
Every half an hour throughout surgery
|
|
Variation in the ST-segment of the ECG
Time Frame: Every fifteen minutes throughout surgery
|
Every fifteen minutes throughout surgery
|
|
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.
|
Every fifteen minutes throughout surgery
|
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.
|
Every fifteen minutes throughout surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kamilla Nielsen, MD, Rigshospitalet, Denmark
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
August 24, 2009
First Submitted That Met QC Criteria
August 26, 2009
First Posted (Estimate)
August 27, 2009
Study Record Updates
Last Update Posted (Estimate)
February 25, 2011
Last Update Submitted That Met QC Criteria
February 24, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-C-2009-072
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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