Blood Management in Orthopedic Surgery

Osteoarthritis Clinical Trial

— TOMaat  

Official title:

Optimal Blood Management in Elective Orthopaedic Surgery: The Transfusion "Op Maat" (TOMaat) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00998088
• Other study ID #: ISRCTN96327523
• Secondary ID: ISRCTN96327523NT
• Status: Completed
• Phase: Phase 4
• First received: October 19, 2009
• Last updated: October 19, 2009
• Start date: May 2004
• Est. completion date: September 2009

Study information

• Verified date: October 2009
• Source: Sanquin Research & Blood Bank Divisions
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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.

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2598
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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

Drug:
• erythropoietin
weekly 40.000 IU s.c. for 4 weeks pre-operatively

Device:
• OrthoPAT
for intra- and post-operative re-infusion of autologous wound blood
• Post-operative drain device
For post-operative re-infusion of unwashed wound blood

Other:
• Erythropoietin and OrthoPAT
weekly 40.000 IU s.c. for 4 weeks pre-operatively
• Erythropoietin and drain device
weekly 40.000 IE s.c.for 4 weeks pre-operatively; drain use in post-operative period

Device:
• OrthoPAT
For intra- and post-operative reinfusion of autologous blood

Locations

Country	Name	City	State
Netherlands	Slotervaart Hospital	Amsterdam	Noord-Holland
Netherlands	Albert Schweitzer Hospital	Dordrecht	Zuid-Holland
Netherlands	Groene Hart Hospital	Gouda	Zuid Holland
Netherlands	LUMC	Leiden	Zuid-Holland

Sponsors (4)

Lead Sponsor	Collaborator
Sanquin Research & Blood Bank Divisions	Haemonetics Corporation, Roche BV Netherlands, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of allogeneic red blood cell (RBC) transfusions.		up to 3 months after surgery	No
Secondary	Peri- and post-operative complications during hospitalization		up to 3 months after surgery	No
Secondary	Rehabilitation time		in hospital	No
Secondary	Hb/Ht post-operative		at 14 days and 3 months after surgery	No
Secondary	Quality of life		Up to 3 months after surgery	No
Secondary	Transfusion reactions		up to 3 months after surgery	Yes
Secondary	Harris hip / knee society score (for determination of the mobility of the operated joint)		pre-operative and after 3 months	No
Secondary	Cost analysis		up to 3 months after surgery	No
Secondary	Length of hospital stay		In hospital	No