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Optimal blood management in elective orthopaedic surgery. The Transfusion "Op Maat" (TOMaat) study.

Optimal blood management in elective orthopaedic surgery. The Transfusion "Op Maat" (TOMaat) study.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24569
Enrollment
2250
Registered
2005-09-12
Start date
2004-05-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary and revision total knee (TKR)-and hip replacement (THR) surgery patients.

Interventions

Stratification depending on the pre-operative Hemoglobin (Hb) level: Stratum I: 6,1 mmol/L 8,1 mmol/L (not eligible for Epo). Patients in both strata will be sequentially randomised for: a. no use of

Sponsors

LUMC, department of Orthopaedics
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All orthopedic patients of 18 years and older being considered for a primary or revision total knee replacement (TKR) or total hip replacement (THR).

Exclusion criteria

Exclusion criteria: Refusal of allogeneic blood, pregnancy, patients with uncontrolled hypertension, cardiac instability, recent CVA, symptomatic atherosclerosis, sickle cell anaemia, cancer in the wound area , unsuitability for peri-operative anticoagulation prophylaxis, known allergy to erythropoietin and patients with an infected prosthesis or wound.

Design outcomes

Primary

MeasureTime frame
Number of red blood cell (RBC) transfusions in the following blood management strategies: 1. Comparison of Epo versus no Epo; 2. Comparison of cell saver versus no cell saver; 3. Comparison of drain system versus no drain system, independent of cell saver.

Secondary

MeasureTime frame
Postoperative complications, length of hospital stay (LOHS), postoperative Hb/haematocrit (Hct), rehabilitation time, mobility and functional abilities of knee-or hip, quality of life scores, costs analysis.

Contacts

Public ContactCynthia So-Osman

Sanquin Bloodbank ZW, Plesmanlaan 1a

C.So@sanquin.nl+31 (0)71 5685136

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)