Advice
Clinical and technical evidence
Clinical and technical evidence
A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.
Published evidence
This briefing summarises 3 randomised controlled trials including 209 patients. Two are fully published journal articles (n=155) and the other is a conference abstract reporting results from a 2016 trial (n=54). Table 2 summarises the clinical evidence as well as its strengths and limitations.
Overall assessment of the evidence
There are very few published studies using Hemosep, and those that exist have small sample sizes and are most likely underpowered to detect a true difference between groups. Two of the studies were part-funded by the manufacturer.
Two of the 3 studies in this briefing were done in the UK, making their results relevant to NHS practice.
Larger trials are needed to improve the evidence base for the effectiveness of Hemosep compared with standard care. Hogan et al. (2015) commented that larger trials could compare Hemosep with other haemofiltration methods, centrifugation cell salvage methods, bagged pumped blood and allogenic blood transfusion. They estimated that around 176 patients would be needed per group for adequate statistical power for their study design.
Table 2: Summary of included studies
|
Study size, design and location |
RCT including 54 low-risk cardiac patients from St Thomas' NHS Trust, London. |
|
Intervention and comparator(s) |
The intervention group received autologous blood returned from the Hemosep device. The comparator group had autologous red blood cells returned from cell salvage. |
|
Key outcomes |
Cell saver volume was significantly higher in the intervention group. PT was shorter in the intervention group postoperatively. aPTT was increased in the intervention group following transfusion. DDimer and ETP were higher in the comparator group following transfusion. |
|
Strengths and limitations |
NHS-based, has good relevance to NHS practice. Conference abstract and so limited details of the study are available. |
|
Study size, design and location |
RCT including 102 cardiac patients with a EuroSCORE exceeding 6 from University of Kirikkale (Turkey). |
|
Intervention and comparator(s) |
The intervention group received autologous blood returned from the Hemosep device. The comparator group had blood salvaged by conventional methods without the use of a haemoconcentrator. |
|
Key outcomes |
Within the Hemosep group, haematocrit, white blood cells, serum albumin and blood coagulation factor VII levels were all statistically significantly concentrated after 15 and 40 minutes compared to baseline. Levels of post-operative bleeding were not significantly different between groups. Patients in the control group received statistically significantly more perioperative allogenic RBCs compared to the intervention group. Statistically significantly more patients within the control group needed a transfusion perioperatively compared to patients within the intervention group. |
|
Strengths and limitations |
Not UK-based and so generalisability to the NHS is unclear. Doesn't fully explain what is meant by standard care. General lack of discussion. |
|
Study size, design and location |
RCT including 53 patients with a EuroSCORE above a mean of 4.8 from Papworth Hospital NHS Foundation Trust. |
|
Intervention and comparator(s) |
The intervention group received residual blood concentrated using Hemosep. The comparator group received heparinised (but not concentrated) residual cardiopulmonary bypass blood. |
|
Key outcomes |
There was no difference between groups in haemoglobin concentration, platelets, PT or aPTT after autotransfusion. There was no difference between groups in the rate of red blood cell, platelets or FFP transfusions with 12 hours after surgery. There was no difference in blood loss within 12 hours after surgery between groups. The intervention group did show a reduction in weight of blood compared to the comparator group. |
|
Strengths and limitations |
NHS-based, has good relevance to NHS practice. Brightwake provided an unrestricted educational grant. |
|
Abbreviations: ETP, endogenous thrombin potential; FFP, fresh frozen plasma; RBC, red blood cell; RCT, randomised controlled trial; PT, prothrombin time; aPPT, activated partial thromboplastin time. |
|