Establishment of Optimal Transfusion Threshold During Spine Surgery

February 24, 2011 updated by: Rigshospitalet, Denmark
The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the tissue oxygenation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Østerbro
      • Copenhagen, Østerbro, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
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
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in subcutaneous oxygen tension from incision.
Time Frame: 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).
Every fifteen minutes throughout surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

TrygFonden, Denmark

Investigators

  • Principal Investigator: Kamilla Nielsen, MD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

August 24, 2009

First Submitted That Met QC Criteria

August 26, 2009

First Posted (Estimate)

August 27, 2009

Study Record Updates

Last Update Posted (Estimate)

February 25, 2011

Last Update Submitted That Met QC Criteria

February 24, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-C-2009-072

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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