OsteoarthritisPhase 4TOMaatNCT00998088
Blood Management in Orthopedic Surgery
A Phase 4 study testing erythropoietin and cell saver, erythropoietin and OrthoPAT in people with Osteoarthritis, run by Sanquin Research & Blood Bank Divisions at 4 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- erythropoietin and cell saver, erythropoietin and OrthoPAT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,598 participants
- Where
- 4 sitesNetherlands
- Study dates
- May 2004to Sep 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Orthopaedic patients of 18 years and older being scheduled for a primary or revision total knee (TKR) or total hip replacement (THR).
Who cannot join
- 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,
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- 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).
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Slotervaart Hospital
Amsterdam, North Holland
Albert Schweitzer Hospital
Dordrecht, South Holland
Groene Hart Hospital
Gouda, South Holland
LUMC
Leiden, South Holland
About this study
Official title: Optimal Blood Management in Elective Orthopaedic Surgery: The Transfusion "Op Maat" (TOMaat) Study
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.
Read more
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
Read the 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).
- Conditions
- Osteoarthritis
- Being tested
- erythropoietin and cell saver, erythropoietin, OrthoPAT, Post-operative drain device, Erythropoietin and OrthoPAT
- Keywords
- Blood management, Orthopedic surgery, elective, randomized study, adults, hip replacement, knee replacement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erythropoietin and cell saverOther
Also called Eprex, Ortho-Biotech, Neorecormon, Roche, OrthoPAT, Haemonetics
weekly 40.000 IU s.c. for 4 weeks pre-operatively; use of cell saver includes intra- and post-operative drainage and reinfusion
erythropoietinDrug
Also called Eprex, Ortho-Biotech, Neorecormon, Roche
weekly 40.000 IU s.c. for 4 weeks pre-operatively
OrthoPATDevice
Also called OrthoPAT, Haemonetics
for intra- and post-operative re-infusion of autologous wound blood
Post-operative drain deviceDevice
Also called Bellovac-ABT, Astra-Tech, The Netherlands, DONOR-drain, Van Straten Medical, The Netherlands
For post-operative re-infusion of unwashed wound blood
Erythropoietin and OrthoPATOther
Also called Eprex, Ortho-Biotech, Neorecormon, Roche, OrthoPAT, Haemonetics
weekly 40.000 IU s.c. for 4 weeks pre-operatively
Erythropoietin and drain deviceOther
Also called Eprex, Ortho-Biotech, Neorecormon, Roche, Bellovac-ABT, Astra-Tech, DONOR-drain, Van Straten Medical
weekly 40.000 IE s.c.for 4 weeks pre-operatively; drain use in post-operative period
OrthoPATDevice
Also called OrthoPAT, Haemonetics
For intra- and post-operative reinfusion of autologous blood
| Study group | Role | What they receive |
|---|---|---|
| Erythropoietin | Experimental | Not described Receives: Drug: erythropoietin |
| Control arm | No intervention | Not described |
| cell saver | Experimental | Not described Receives: Device: OrthoPAT |
| drain | Experimental | Not described Receives: Device: Post-operative drain device |
| Erythropoietin and cell saver | Experimental | Not described Receives: Other: erythropoietin and cell saver; Other: Erythropoietin and OrthoPAT |
| Erythropoietin and drain | Experimental | Not described Receives: Other: Erythropoietin and drain device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of allogeneic red blood cell (RBC) transfusions.
Measured: up to 3 months after surgery
Secondary outcomes (8)
Peri- and post-operative complications during hospitalization
Measured: up to 3 months after surgery
Rehabilitation time
Measured: in hospital
Hb/Ht post-operative
Measured: at 14 days and 3 months after surgery
Quality of life
Measured: Up to 3 months after surgery
Transfusion reactions
Measured: up to 3 months after surgery
Harris hip / knee society score (for determination of the mobility of the operated joint)
Measured: pre-operative and after 3 months
Cost analysis
Measured: up to 3 months after surgery
Length of hospital stay
Measured: In hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startMay 2004
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 2,598 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanquin Research & Blood Bank Divisions
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Roche BV Netherlands, Haemonetics Corporation
- Investigators
- Rob Nelissen, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998088
- Sponsor's protocol ID
- ISRCTN96327523
- Other IDs
- ISRCTN96327523, NTR303, ZonMW945-06-601, Sanquin PPOC-03-002
- Acronym
- TOMaat
- Status last verified
- Oct 2009
- First submitted
- 19 Oct 2009
- Last updated
- 20 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Blood Management in Elective Orthopaedic Surgery: The Transfusion "Op Maat" (TOMaat) Study
- ClinicalTrials.gov ID
- NCT00998088
- Acronym / sponsor ID
- TOMaat / ISRCTN96327523
- Conditions
- Osteoarthritis
- Keywords
- Blood management, Orthopedic surgery, elective, randomized study, adults, hip replacement, knee replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,598 participants (actual)
- Lead sponsor
- Sanquin Research & Blood Bank DivisionsUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Roche BV Netherlands, Haemonetics Corporation
- Study start
- May 2004
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 20 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Erythropoietin | Experimental | Drug: erythropoietin |
| Control arm | No intervention | – |
| cell saver | Experimental | Device: OrthoPAT |
| drain | Experimental | Device: Post-operative drain device |
| Erythropoietin and cell saver | Experimental | Other: erythropoietin and cell saver, Other: Erythropoietin and OrthoPAT |
| Erythropoietin and drain | Experimental | Other: Erythropoietin and drain device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Orthopaedic patients of 18 years and older being scheduled for a primary or revision total knee (TKR) or total hip replacement (THR).
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| erythropoietin and cell saverAlso: Eprex, Ortho-Biotech, Neorecormon, Roche, OrthoPAT, Haemoneticsweekly 40.000 IU s.c. for 4 weeks pre-operatively; use of cell saver includes intra- and post-operative drainage and reinfusion | Other | Erythropoietin and cell saver |
| erythropoietinAlso: Eprex, Ortho-Biotech, Neorecormon, Rocheweekly 40.000 IU s.c. for 4 weeks pre-operatively | Drug | Erythropoietin |
| OrthoPATAlso: OrthoPAT, Haemoneticsfor intra- and post-operative re-infusion of autologous wound blood | Device | cell saver |
| Post-operative drain deviceAlso: Bellovac-ABT, Astra-Tech, The Netherlands, DONOR-drain, Van Straten Medical, The NetherlandsFor post-operative re-infusion of unwashed wound blood | Device | drain |
| Erythropoietin and OrthoPATAlso: Eprex, Ortho-Biotech, Neorecormon, Roche, OrthoPAT, Haemoneticsweekly 40.000 IU s.c. for 4 weeks pre-operatively | Other | Erythropoietin and cell saver |
| Erythropoietin and drain deviceAlso: Eprex, Ortho-Biotech, Neorecormon, Roche, Bellovac-ABT, Astra-Tech, DONOR-drain, Van Straten Medicalweekly 40.000 IE s.c.for 4 weeks pre-operatively; drain use in post-operative period | Other | Erythropoietin and drain |
| OrthoPATAlso: OrthoPAT, HaemoneticsFor intra- and post-operative reinfusion of autologous blood | Device | cell saver |
Primary outcome
Number of allogeneic red blood cell (RBC) transfusions.
Time frame: up to 3 months after surgery
8 secondary outcomes
Peri- and post-operative complications during hospitalization
Time frame: up to 3 months after surgery
Rehabilitation time
Time frame: in hospital
Hb/Ht post-operative
Time frame: at 14 days and 3 months after surgery
Quality of life
Time frame: Up to 3 months after surgery
Transfusion reactions
Time frame: up to 3 months after surgery
Harris hip / knee society score (for determination of the mobility of the operated joint)
Time frame: pre-operative and after 3 months
Cost analysis
Time frame: up to 3 months after surgery
Length of hospital stay
Time frame: In hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob Nelissen, MD, PhD principal investigator
Leiden University Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing erythropoietin and cell saver, erythropoietin and OrthoPAT in people with Osteoarthritis, run by Sanquin Research & Blood Bank Divisions at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of allogeneic red blood cell (RBC) transfusions. (time frame: up to 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2009.