Blood Management in Orthopedic Surgery - Full Text View

Sponsor:	Sanquin Research & Blood Bank Divisions
Collaborators:	ZonMw: The Netherlands Organisation for Health Research and Development Roche BV Netherlands Haemonetics Corporation
Information provided by:	Sanquin Research & Blood Bank Divisions
ClinicalTrials.gov Identifier:	NCT00998088

Purpose

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

Condition	Intervention	Phase
Osteoarthritis	Other: erythropoietin and cell saver Drug: erythropoietin Device: OrthoPAT Device: Post-operative drain device Other: Erythropoietin and OrthoPAT Other: Erythropoietin and drain device	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Optimal Blood Management in Elective Orthopaedic Surgery: The Transfusion "Op Maat" (TOMaat) Study

Resource links provided by NLM:

MedlinePlus related topics: Blood Transfusion and Donation Hip Replacement Osteoarthritis Rehabilitation

Drug Information available for: Erythropoietin Epoetin alfa Epoetin beta

U.S. FDA Resources

Further study details as provided by Sanquin Research & Blood Bank Divisions:

Primary Outcome Measures:

Number of allogeneic red blood cell (RBC) transfusions. [ Time Frame: up to 3 months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Peri- and post-operative complications during hospitalization [ Time Frame: up to 3 months after surgery ] [ Designated as safety issue: No ]
Rehabilitation time [ Time Frame: in hospital ] [ Designated as safety issue: No ]
Hb/Ht post-operative [ Time Frame: at 14 days and 3 months after surgery ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: Up to 3 months after surgery ] [ Designated as safety issue: No ]
Transfusion reactions [ Time Frame: up to 3 months after surgery ] [ Designated as safety issue: Yes ]
Harris hip / knee society score (for determination of the mobility of the operated joint) [ Time Frame: pre-operative and after 3 months ] [ Designated as safety issue: No ]
Cost analysis [ Time Frame: up to 3 months after surgery ] [ Designated as safety issue: No ]
Length of hospital stay [ Time Frame: In hospital ] [ Designated as safety issue: No ]

Enrollment:	2598
Study Start Date:	May 2004
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Erythropoietin	Drug: erythropoietin weekly 40.000 IU s.c. for 4 weeks pre-operatively Other Names: Eprex, Ortho-Biotech Neorecormon, Roche
No Intervention: Control arm
Experimental: cell saver	Device: OrthoPAT for intra- and post-operative re-infusion of autologous wound blood Other Name: OrthoPAT, Haemonetics Device: OrthoPAT For intra- and post-operative reinfusion of autologous blood Other Name: OrthoPAT, Haemonetics
Experimental: drain	Device: Post-operative drain device For post-operative re-infusion of unwashed wound blood Other Names: Bellovac-ABT, Astra-Tech, The Netherlands DONOR-drain, Van Straten Medical, The Netherlands
Experimental: Erythropoietin and cell saver	Other: erythropoietin and cell saver weekly 40.000 IU s.c. for 4 weeks pre-operatively; use of cell saver includes intra- and post-operative drainage and reinfusion Other Names: Eprex, Ortho-Biotech Neorecormon, Roche OrthoPAT, Haemonetics Other: Erythropoietin and OrthoPAT weekly 40.000 IU s.c. for 4 weeks pre-operatively Other Names: Eprex, Ortho-Biotech Neorecormon, Roche OrthoPAT, Haemonetics
Experimental: Erythropoietin and drain	Other: Erythropoietin and drain device weekly 40.000 IE s.c.for 4 weeks pre-operatively; drain use in post-operative period Other Names: Eprex, Ortho-Biotech Neorecormon, Roche Bellovac-ABT, Astra-Tech DONOR-drain, Van Straten Medical

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998088

Locations

Netherlands
Slotervaart Hospital
Amsterdam, Noord-Holland, Netherlands
Groene Hart Hospital
Gouda, Zuid Holland, Netherlands
Albert Schweitzer Hospital
Dordrecht, Zuid-Holland, Netherlands
LUMC
Leiden, Zuid-Holland, Netherlands

Sponsors and Collaborators

Sanquin Research & Blood Bank Divisions

ZonMw: The Netherlands Organisation for Health Research and Development

Roche BV Netherlands

Haemonetics Corporation

Investigators

Principal Investigator:

Rob Nelissen, MD, PhD

Leiden University Medical Center

More Information

No publications provided

Responsible Party:	Prof. Dr.R.G.H.H.Nelissen, Leiden University Medical Center
ClinicalTrials.gov Identifier:	NCT00998088 History of Changes
Other Study ID Numbers:	ISRCTN96327523, ISRCTN96327523, NTR303, ZonMW945-06-601, Sanquin PPOC-03-002
Study First Received:	October 19, 2009
Last Updated:	October 19, 2009
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Sanquin Research & Blood Bank Divisions:

Blood management
Orthopedic surgery
elective
randomized study

adults
hip replacement
knee replacement

Additional relevant MeSH terms:

Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012