Westbrook 2009.
Methods | Two‐group parallel RCT, one centre ITT: unclear Funding: unclear Overall study quality: high risk of bias No sample size calculation was reported |
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Participants | All patients presenting for cardiac surgery with the exception of lung transplantation. 10% of the control group and 9.38% of the TEG group were patients with urgent presentation | |
Interventions |
Intervention group: TEG (plain and heparinase coated cups) before bypass in the re‐warming phase (core body temperature > 36.5 °C), and 15 min after protamine administration (dose matching total heparin dose) at the end of bypass. Platelet Mapping in patients taking aspirin or clopidogrel immediately prior to induction of anaesthesia. Transfusion of blood products, administration of protamine and/or procoagulant blood products strictly according to predefined protocols based on several TEG measurements alone. In ICU transfusion strategy and treatment (additional administration of protamine) strictly according to protocols and TEG analyses. In ICU protocols for: postop ICU monitoring, ICU surgical intervention, Novo 7 administration and ICU red blood cell replacement Control group: transfusion strategy at the attending clinician's discretion based on previous experience and standard coagulation tests (e.g. aPTT, INR, fibrinogen level, platelet count). The timing of these tests were also at clinician's discretion. In case of blood loss > 200 mL over 15 minutes, activated factor 7 was considered Re‐sternotomy was performed when sustained bleeding > 100 mL/hour in the presence of a normal TEG. Timing of a re‐sternotomy was at clinician's discretion Concomitant treatment: aprotinin was used in 41.6% of control group during surgery versus 40.6 in the TEG group |
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Outcomes | Blood loss, intubation time (hours), minimum Hb (g/L), ICU stay, hospital stay (days) | |
Notes |
Country: Australia. Language: English Letter sent to authors in June 2010. No reply received Follow‐up: until hospital discharge Statistical issues: results are based on number of blood units given to each group instead of each patient, hereby wrongly assuming that each unit of blood is independently given Authors conclusion:"This pilot study suggests that a strict protocol for blood product replacement based on the TEG might be highly effective in reducing usage without impairing short‐term outcome" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Unclear, no information provided. |
Allocation concealment (selection bias) | Unclear risk | Unclear, no information provided. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Unclear to which extend the blinding took place but the surgeons were blinded as to the group allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Appears to have adequate follow‐up. |
Selective reporting (reporting bias) | Low risk | Unable to compare with protocol or trial registration but appears to be free of selective reporting. |
Other bias | Unclear risk | No information on funding but otherwise appears free of other types of bias. |
Please see Appendix 4 for abbreviations.