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Establishment of Optimal Transfusion Threshold During Spine Surgery

Primary Purpose

Anemia, Spine Surgery

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional supportive care trial for Anemia focused on measuring Anemia, Tissue oxygenation, Spine surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

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

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

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Oxygenation of the brain

The concentration of lactate in plasma

Variation in the ST-segment of the ECG

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.

The change in subcutaneous oxygen tension from incision.

The lowest measured subcutaneous oxygen tension and the last measured subcutaneous oxygen tension throughout surgery.

Full Information

NCT ID

NCT00967109

First Posted

August 24, 2009

Last Updated

February 24, 2011

Sponsor

Rigshospitalet, Denmark

Collaborators

TrygFonden, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT00967109

Brief Title

Establishment of Optimal Transfusion Threshold During Spine Surgery

Official Title

Establishment of Optimal Transfusion Threshold During Spine Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Rigshospitalet, Denmark

Collaborators

TrygFonden, Denmark

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, Spine Surgery

Keywords

Anemia, Tissue oxygenation, Spine surgery

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Arm Title

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

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

Transfusion with red blood cells to hemoglobin level between 4,5-5,5 mmol/L

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

Transfusion with red blood cells to hemoglobin level between 5,6-6,5 mmol/L

Primary Outcome Measure Information:

Title

The change in subcutaneous oxygen tension from incision.

Description

Time Frame

Every fifteen minutes throughout surgery

Secondary Outcome Measure Information:

Title

Oxygenation of the brain

Time Frame

Every fifteen minutes throughout surgery

Title

The concentration of lactate in plasma

Time Frame

Every half an hour throughout surgery

Title

Variation in the ST-segment of the ECG

Time Frame

Every fifteen minutes throughout surgery

Title

Muscular saturation of the deltoid muscle

Description

Time Frame

Every fifteen minutes throughout surgery

Title

The change in subcutaneous oxygen tension from incision.

Description

The lowest measured subcutaneous oxygen tension and the last measured subcutaneous oxygen tension throughout surgery.

Time Frame

Every fifteen minutes throughout surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kamilla Nielsen, MD

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rigshospitalet

City

Copenhagen

State/Province

Østerbro

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

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Establishment of Optimal Transfusion Threshold During Spine Surgery

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