DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Blood Management in Orthopedic Surgery

Information source: Sanquin Research & Blood Bank Divisions
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoarthritis

Intervention: erythropoietin and cell saver (Other); erythropoietin (Drug); OrthoPAT (Device); Post-operative drain device (Device); Erythropoietin and OrthoPAT (Other); Erythropoietin and drain device (Other); OrthoPAT (Device)

Phase: Phase 4

Status: Completed

Sponsored by: Sanquin Research & Blood Bank Divisions

Official(s) and/or principal investigator(s):
Rob Nelissen, MD, PhD, Principal Investigator, Affiliation: Leiden University Medical Center

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

Clinical Details

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

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

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

Secondary outcome:

Peri- and post-operative complications during hospitalization

Rehabilitation time

Hb/Ht post-operative

Quality of life

Transfusion reactions

Harris hip / knee society score (for determination of the mobility of the operated joint)

Cost analysis

Length of hospital stay

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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).

Locations and Contacts

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

Additional Information

Starting date: May 2004
Last updated: October 19, 2009

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017