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Establishment of Optimal Transfusion Threshold During Spine Surgery

NCT ID: NCT00967109

Last Updated: 2011-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-02-28

Brief Summary

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

Detailed Description

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Conditions

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Anemia Spine Surgery

Keywords

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Anemia Tissue oxygenation Spine surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TrygFonden, Denmark

INDUSTRY

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Rigshospitalet

Principal Investigators

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Kamilla Nielsen, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet

Copenhagen, Østerbro, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-C-2009-072

Identifier Type: -

Identifier Source: org_study_id