NCT00967109

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

February 25, 2011

Status Verified

February 1, 2011

Enrollment Period

1.3 years

First QC Date

August 24, 2009

Last Update Submit

February 24, 2011

Conditions

AnemiaSpine Surgery

Keywords

AnemiaTissue oxygenationSpine surgery

Outcome Measures

Primary Outcomes (1)

  • 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).

    Every fifteen minutes throughout surgery

Secondary Outcomes (5)

  • 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 subcutaneous oxygen tension from incision.

    Every fifteen minutes throughout surgery

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

EXPERIMENTAL

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

Interventions

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

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

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

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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Patients undergoing spine surgery
  • Be legally competent
  • Read and understand Danish

You may not qualify if:

  • Present malignant disease
  • Previously apoplexia cerebri
  • Known heart disease with functionality equivalent to NYHA II or CCS II or worse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Østerbro, 2100, Denmark

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Kamilla Nielsen, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 27, 2009

Study Start

September 1, 2009

Primary Completion

January 1, 2011

Study Completion

February 1, 2011

Last Updated

February 25, 2011

Record last verified: 2011-02

Locations

DK(1)