Establishment of Optimal Transfusion Threshold During Spine Surgery

Rigshospitalet

Status: Completed

Conditions: Spine Surgery; Anemia

Treatments: Other: Allowed drop in hemoglobin to level between 5,6-6,5 mmol/L; Other: Allowed drop in hemoglobin to level between 4,5-5,6 mmol/L

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00967109

H-C-2009-072

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups

Allowed drop in hemoglobin to 4,5-5,5 mmol/L

Active Comparator group

Description:

Transfusion with red blood cells to level between 4.5-5.5 mmol/L

Treatment:

Other: Allowed drop in hemoglobin to level between 4,5-5,6 mmol/L

Allowed drop in hemoglobin to 5,5-6,5 mmol/L

Experimental group

Description:

Transfusion with red blood cells to level between 5.5-6.5 mmol/L

Treatment:

Other: Allowed drop in hemoglobin to level between 5,6-6,5 mmol/L