Clinical trial NCT00998088: Blood Management in Orthopedic Surgery
Official title: Optimal Blood Management in Elective Orthopaedic Surgery: The Transfusion "Op Maat" (TOMaat) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: Blood management
Orthopedic surgery
elective
randomized study
adults
hip replacement
knee replacement
Lead sponsor: Sanquin Research & Blood Bank Divisions
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Roche BV Netherlands
name: Haemonetics Corporation
First posted: 2009-10-20
Enrollment: 2598
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Aim: to investigate whether the use of several transfusion alternatives (erythropoietin, the cell-saver or postoperative drainage and reinfusion systems) in patients undergoing elective total knee or hip replacement surgery can lead to allogeneic red blood cell (RBC) saving if a restrictive transfusion policy is used.

Study design: a prospective, double randomized, open, multicenter study in which patients are stratified according to their preoperative hemoglobin(Hb) level: stratum I= Hb between 6,1 and 8,2 mmol/l. These patients are first randomized for Erythropoetin (Epo) or no Epo.

Stratum II= Hb of 6,1 and lower or 8,2 mmol/l and higher, are not eligible for Epo and thus not randomized. Patients in both strata will be randomized for three modalities: a cell saver (CS)(to wash, filter and reinfuse autologous shed blood) which is used intra- and postoperatively or a postoperative autologous reinfusion drainage system (D) only (to filter and reinfuse autologous shed blood) or a restrictive transfusion trigger only (controls).

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

Outcome measures:

Primary outcome: number of allogeneic red blood cell (RBC) transfusions.

Secondary outcome: transfusion reactions, rehabilitation time, length of hospital stay (days), peri- and post-operative complications during hospitalization, quality of life, cost analysis

Detailed description: Power/data analysis: In order to be able to detect a 75% reduction of allogeneic transfusions by Epo and a reduction of 30% by autologous (shed blood) transfusions (CS or D) with a power= 0.9 and an alpha= 0.05, inclusion of 2250 surgery patients (in a worst case scenario of high standard deviations) are required for intention-to-treat analysis.

Knee surgery patients are not randomized for cell saver (no intra-operative blood loss).

Eligibility criteria: Inclusion Criteria:

* Orthopaedic patients of 18 years and older being scheduled for a primary or revision total knee (TKR) or total hip replacement (THR).

Exclusion Criteria:

* Patients who refuse homologous blood (e.g.Jehovah's witnesses),
* Patients with untreated hypertension (diastolic blood pressure \> 95 mm Hg),
* Patients with a serious disorder of the coronary artery, peripheral arteries and/or carotid arteries,
* A recent myocardial infarction or CVA,
* Sickle cell anaemia patients,
* Malignancy in the operated area,
* Pregnancy,
* Unsuitability for peri-operative anticoagulation prophylaxis,
* Known allergy to erythropoietin,
* An infected wound bed,
* Revision of an infected prosthesis which is being treated with antibiotics, OR
* Patients with difficulty understanding the Dutch language (unable to give informed consent or patients who insufficiently control the Dutch language).

Primary outcomes:
measure: Number of allogeneic red blood cell (RBC) transfusions.
timeFrame: up to 3 months after surgery
Secondary outcomes:
measure: Peri- and post-operative complications during hospitalization
timeFrame: up to 3 months after surgery
measure: Rehabilitation time
timeFrame: in hospital
measure: Hb/Ht post-operative
timeFrame: at 14 days and 3 months after surgery
measure: Quality of life
timeFrame: Up to 3 months after surgery
measure: Transfusion reactions
timeFrame: up to 3 months after surgery
measure: Harris hip / knee society score (for determination of the mobility of the operated joint)
timeFrame: pre-operative and after 3 months
measure: Cost analysis
timeFrame: up to 3 months after surgery
measure: Length of hospital stay
timeFrame: In hospital
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Slotervaart Hospital
state: Noord-Holland
city: Gouda
country: Netherlands
facility: Groene Hart Hospital
state: Zuid Holland
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital
state: Zuid-Holland
city: Leiden
country: Netherlands
facility: LUMC
state: Zuid-Holland
Study officials:
affiliation: Leiden University Medical Center
name: Rob Nelissen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: