Establishment of Optimal Transfusion Threshold During Spine Surgery

Anemia Clinical Trial

Official title:

Establishment of Optimal Transfusion Threshold During Spine Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00967109
• Other study ID #: H-C-2009-072
• Status: Completed
• Phase: N/A
• First received: August 24, 2009
• Last updated: February 24, 2011
• Start date: September 2009
• Est. completion date: February 2011

Study information

• Verified date: February 2011
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anemia
• Spine Surgery

Intervention

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
• 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

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	Østerbro

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in subcutaneous oxygen tension from incision.	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	No
Secondary	Oxygenation of the brain		Every fifteen minutes throughout surgery	Yes
Secondary	The concentration of lactate in plasma		Every half an hour throughout surgery	Yes
Secondary	Variation in the ST-segment of the ECG		Every fifteen minutes throughout surgery	Yes
Secondary	Muscular saturation of the deltoid muscle	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	No
Secondary	The change in subcutaneous oxygen tension from incision.	The lowest measured subcutaneous oxygen tension and the last measured subcutaneous oxygen tension throughout surgery.	Every fifteen minutes throughout surgery	No