Objective of this study is to evaluate the amount of shed blood in patients treated with a postoperative retransfusion system. The influence of the position of the drain will be analysed by comparing intra-articular position versus subfascial…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
wondbloed productie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the amount of shed blood used for autologous
retransfusion.
Secondary outcome
Secundary parameters are perioperative hemoglobine levels and the amount of
allogeneic blood transfusions.
Background summary
Prosthetic surgery is associated with considerable blood loss and blood
transfusions are frequently necessary. Blood transfusion is associated with a
number of risks and complications, including allergic reactions, transmission
of infectious agents, and immunomodulatory effects. These potential risks of
allogeneic blood transfusions have led to a more restrictive transfusion
policy. An other alternative to diminish the use of allogeneic blood is
postoperative cell saving (Bellovac retransfusion system). During clinical
orthopaedic practice variable amounts of shed blood was seen in patients
undergoing total hip arthroplasty. As a results variable amounts of
retransfusion will occur, which finally can lead to variable need to use
allogeneic blood transfusions. A possible factor influencing the amounts of
shed blood can be the position of the drain. To our knowledge, there are no
studies analysing the effect of the position of the drain on the amount of shed
blood, certainly not in patients treated with a retransfusion system .
Study objective
Objective of this study is to evaluate the amount of shed blood in patients
treated with a postoperative retransfusion system. The influence of the
position of the drain will be analysed by comparing intra-articular position
versus subfascial position.
Study design
The study design is a prospective randomised clinical trial. All patients are
randomly allocated to group 1 (intra-articulaire drain) or to group 2
(subfasciale drain)
Intervention
In all patients in group 1 the de drain is positioned intra-articular. In all
patients in group 2 the drain is positioned subfasciaal.
Study burden and risks
Safety of a retransfusion system has been proven in the past. Therefore the
risks are minimal to develop adverse events or undesired reactions. The
Bellovac retransfusion system is already used in daily orthopaedic practice.
The burden is also minimal. Patients will receive a retransfusion of shed blood
within 8 hours after surgery. This will take approximately 15 minutes. Both
groups will receive normal peri-operative standard of care. No extra
investigations will take place.
adelbert van scharnlaan s 19
6226 ez
Nederland
adelbert van scharnlaan s 19
6226 ez
Nederland
Listed location countries
Age
Inclusion criteria
Patients sceduled for elective total hip arthroplasty and treated with postoperative retransfusion system
Exclusion criteria
Patients with already threated anemia, any active infection, current malignancy, uncontrolled hypertension, operated in 3 weeks before randomisation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL17352.096.07 |