NCT00906295

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

May 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 6, 2011

Status Verified

June 1, 2011

Enrollment Period

1.9 years

First QC Date

May 20, 2009

Last Update Submit

June 3, 2011

Conditions

AnemiaArthroplastyReplacementHip

Keywords

HemoglobinAmbulation

Outcome Measures

Primary Outcomes (1)

  • Timed Up and Go-test (TUG)in seconds.

    Timed Up and Go-test is performed when the patient is able to undertake the test after surgery. This is judged by a physiotherapist. The test measures how long it takes the patient to rise, walk 3 meters, turn around, walk back and sit down again.

    30 days

Secondary Outcomes (3)

  • The postoperative day patients can walk ten meters

    30 days

  • Length of stay at hospital

    30 days

  • The day the patient is able to perform Timed Up and Go-test

    30 days

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 4.5-5.5 mmol/L

Allowed drop in hemoglobin to 5.6-6.5 mmol/L

EXPERIMENTAL

Transfusion with red blood cells to level between 5.6-6.5 mmol/L

Other: Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L

Interventions

Allowed drop in hemoglobin to 4.5-5.5 mmol/LOTHER

Transfusion with red blood cells to hemoglobin between 4.5-5.5 mmol/L (Transfusion threshold of 4.5 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 between hemoglobin 5.6-6.5 mmol/L (Transfusion threshold of 5.5 mmol/L)

Allowed drop in hemoglobin to 5.6-6.5 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 replacement of hip arthroplasty
  • Be legally competent
  • Read and understand Danish

You may not qualify if:

  • Present malignant disease
  • 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 (2)

Bispebjerg Hospital

Copenhagen, Copenhagen NV, 2400, Denmark

Location

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Østerbro, 2100, Denmark

Location

Related Publications (3)

  • Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

    PMID: 41114449DERIVED

  • Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.

    PMID: 34932836DERIVED

  • Nielsen K, Johansson PI, Dahl B, Wagner M, Frausing B, Borglum J, Jensen K, Sturup J, Hvolris J, Rasmussen LS. Perioperative transfusion threshold and ambulation after hip revision surgery--a randomized trial. BMC Anesthesiol. 2014 Oct 10;14:89. doi: 10.1186/1471-2253-14-89. eCollection 2014.

    PMID: 25337035DERIVED

Related Links

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
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 20, 2009

First Posted

May 21, 2009

Study Start

June 1, 2009

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

June 6, 2011

Record last verified: 2011-06

Locations

DK(2)