Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery

NCT ID: NCT00906295

Last Updated: 2011-06-06

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

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-06-30

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 postoperative ambulation.

Detailed Description

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Conditions

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Anemia Arthroplasty Replacement Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants 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 4.5-5.5 mmol/L

Intervention Type OTHER

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 5.6-6.5 mmol/L

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

Interventions

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Allowed drop in hemoglobin to 4.5-5.5 mmol/L

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

Intervention Type OTHER

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

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* Patients undergoing replacement of hip arthroplasty
* Be legally competent
* Read and understand Danish

Exclusion Criteria

* Present malignant disease
* 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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Bispebjerg Hospital

Copenhagen, Copenhagen NV, Denmark

Site Status

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Østerbro, Denmark

Site Status

Countries

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Denmark

References

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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:CD002042. doi: 10.1002/14651858.CD002042.pub6.

Reference Type DERIVED
PMID: 41114449 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34932836 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25337035 (View on PubMed)

Related Links

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http://www.rigshospitalet.dk

Official hospital homepage

Other Identifiers

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H-D-2009-024

Identifier Type: -

Identifier Source: org_study_id

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