Establishment of Optimal Transfusion Threshold During Spine Surgery

Not Applicable

Completed

• Conditions: Anemia; Spine Surgery
• Interventions: 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

• Registration Number: NCT00967109
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-26
• Study First Posted: 2009-08-27
• Study Start: 2009-09
• Primary Completion: 2011-01
• Status Verified: 2011-02
• Study Completion: 2011-02
• Last Update Submitted: 2011-02-24
• Last Update Posted: 2011-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allowed drop in hemoglobin to 4,5-5,5 mmol/L	Allowed drop in hemoglobin to level between 4,5-5,6 mmol/L	Transfusion with red blood cells to level between 4.5-5.5 mmol/L
Allowed drop in hemoglobin to 5,5-6,5 mmol/L	Allowed drop in hemoglobin to level between 5,6-6,5 mmol/L	Transfusion with red blood cells to level between 5.5-6.5 mmol/L

Primary Outcome Measures

Name	Time	Method
The change in subcutaneous oxygen tension from incision.	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

Name	Time	Method
Oxygenation of the brain	Every fifteen minutes throughout surgery
The concentration of lactate in plasma	Every half an hour throughout surgery
Variation in the ST-segment of the ECG	Every fifteen minutes throughout surgery
Muscular saturation of the deltoid muscle	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.
The change in subcutaneous oxygen tension from incision.	Every fifteen minutes throughout surgery	The lowest measured subcutaneous oxygen tension and the last measured subcutaneous oxygen tension throughout surgery.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Østerbro, Denmark