Is the use of postoperative autologous retransfusion drainage (ARD) systems useful in hip and knee arthroplasty?
ID
Source
Brief title
Condition
- Joint disorders
- Vascular therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the amount of allogeneic blood transfusions in the
three groups. Allogeneic blood transfusions are given by specific haemoglobin
levels.
Secondary outcome
Secondary endpoints are haemoglobin levels in the perioperative period, and
complications with special focus on wound problems after surgery. Furthermore,
all clinical data will be collected such as length of hospitalisation, co
morbidity and others.
Background summary
Use of post operative wound drains in hip and knee arthroplasty is still
debated. Drainage is said to reduce wound haematoma, improves wound healing and
prevents infection. Therefore many patients are treated with wound drainage
until the first postoperative day. However, it is also said that continual
drainage after surgery will increase the amount of shed blood because the
counteraction of haematoma formation will not take place. In addition, drains
may act as access route for bacterial contamination of the wound which can
cause a periprosthetic infection. This favours no drainage at all. These
assumptions are based on results in patients where a drain was used as a
drainage system only. However, retransfusion drainage systems after
arthroplasty are gaining popularity. These retransfusion systems are used to
reduce the need for allogeneic blood transfusions. It is interesting if the
potential benefits outweigh the controversial thoughts in drainage. Therefore
we want to evaluate whether drainage, using a retransfusion system, after major
arthroplasty is useful at all.
Study objective
Is the use of postoperative autologous retransfusion drainage (ARD) systems
useful in hip and knee arthroplasty?
Study design
After inclusion, patients are randomised into three groups. Group 1: no
drainage, group 2: drainage for 6 hours after surgery and group 3: drainage for
24 hours after surgery. Randomisation with sealed envelopes (stratification per
clinic) will be done at the end of surgery just before wound closure. Shed
blood in group 2 and 3 is collected and retransfused 6 hours after surgery.
After retransfusion the drain is removed in group 2 whereas the drain is
continued for drainage until drain removal the first postoperative morning.
Intervention
An existing intervention will be investigated, autologous retransfusion
drainage with the Bellovac® ABT retransfusion system.
Study burden and risks
There are no potential risks for the patients participating in the trial
Lijnbaan 32
2501 CK Den Haag
NL
Lijnbaan 32
2501 CK Den Haag
NL
Listed location countries
Age
Inclusion criteria
- Patients scheduled to undergo elective major orthopaedic surgery (hip, knee)
- Male and non-pregnant female patients between 18-80 years of age.
- Patients who signed the Ethics Committee approved specific Informed Consent Form prior to surgery.
Exclusion criteria
- Patients with a major surgical procedure during the 12 weeks before the study-related operation.
- No other used alternatives to reduce allogeneic blood transfusions, such as preoperative epoetin alpha (Eprex®) injections or intra-operative cell saving (Sangvia®).
- Clinical or laboratory evidence of untreated iron, folate or vitamin B12 deficiency.
- Recent Myocardial Infarction or CVA (<3 months).
- Dutch language not mastered.
- The patient is pregnant or planning a pregnancy after surgery (or is using inadequate birth control).
- Mentally disabled patients.
- Current malignancy or any active infection.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL27458.098.10 |