The purpose of this study is to document the efficacy, measured by allogeneic blood transfusion rate, of the Sangvia® Blood Management System when used for intra-operative, and if bleeding continues after surgery, possibly also postoperative…
ID
Source
Brief title
Condition
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Frequency and amount of allogeneic blood transfusion
Secondary outcome
- Post-operative infection rate (SIRS reaction, clinical symptoms, wound
infection, CRP and LPC)
- Post-operative antibiotic use
- Length of hospital stay
- Post-operative haemoglobin concentration
- Demographical data (e.g. vital signs, age, gender etc)
- Health status questionnaire (i.e. EQ-5D)
Background summary
Transfusion of postoperative autologous blood has been found to reduce the need
for allogeneic
blood transfusion and also reduce the number of postoperative infections.
Publications
on the effect of intraoperative filtrated whole blood collection and
transfusion are however today
very limited or non-existing. The purpose of this study is to document the
efficacy, measured by
allogeneic blood transfusion rate, of the Sangvia® Blood Management System when
used for
intra-operative, and if bleeding continues after surgery, possibly also
postoperative autologous
whole blood transfusion in total hip replacement surgery. The study will also
add safety data to
previously reported studies.
Study objective
The purpose of this study is to document the efficacy, measured by allogeneic
blood transfusion rate, of the Sangvia® Blood Management System when used for
intra-operative, and if bleeding continues after surgery, possibly also
postoperative autologous whole blood transfusion in total hip replacement
surgery. The study will also add safety data to
previously reported studies.
Study design
The study is an assessor blind, prospective, randomized, controlled,
multi-centre investigation of
300 patients. Patients will be followed during their hospital stay and at 2
months after discharge.
Intervention
Intra-operative, and if bleeding continues after surgery, possibly also
post-operative autologous
blood transfusion with the Sangvia® system (test group).
Study burden and risks
Patients will as much as possible be followed during hospital stay and at
routine follow-up. The extra blood samples taken from the patient can also be
combined with standard hospital policy.
Aminogatan 1
SE-432 21 Molndal
Sweden
Aminogatan 1
SE-432 21 Molndal
Sweden
Listed location countries
Age
Inclusion criteria
- provision of informed consent
- scheduled for primary or secondary, cemented or non-cemented, total hip arthroplasty
- ASA classification I-III
Exclusion criteria
- current symptoms of haemophilia
- current symptoms of hyperkalaemia
- current symptoms of impaired renal function (normal reference level)
- current untreated anaemia (Hb level < 7 mmo/L)
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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 |
|---|---|
| ClinicalTrials.gov | NCT00822588 |
| CCMO | NL26575.098.09 |