From: Viscoelastic testing for hepatic surgery: a systematic review with meta-analysis—a protocol
Outcome | Criteria | Data type | Planned summary measure |
---|---|---|---|
Primary outcome | 1. 30-day mortality (all-cause) Using mortality data in each eligible trial that is less than and closest to 30 days | Categorical | Relative risk |
Secondary outcomes | 1. Long-term mortality Using mortality data in each eligible trial that is >30 days and the longest follow-up time for that trial | Categorical | Relative risk |
2. Blood loss (mL)—included if measured from the start of surgery, defined a priori and measured equally in both groups. We will use follow-up that is closest to including 24 h after the end of surgery. | Numerical | Standardised mean difference | |
Number of participants receiving blood products—included if measured from the start of surgery, defined a priori and measured equally in both groups. We will use follow-up that is closest to including 24 h after the end of surgery. | Categorical | Relative risk | |
3. Any type of blood product | |||
4. Autologous red blood cells | |||
5. Any type of autologous coagulation factor | |||
6. Autologous fresh frozen plasma | |||
7. Autologous cryoprecipitate | |||
8. Autologous platelets | |||
Volume of blood products administered—included if measured from the start of surgery, defined a priori and measured equally in both groups. We will use follow-up that is closest to including 24 h after the end of surgery. | Numerical | Standardised mean difference | |
9. Red blood cells (mLs or units) | |||
10. Fresh frozen plasma (mLs or units) | |||
11. Cryoprecipitate (mLs or units) | |||
12. Platelets (mLs or units) | |||
Use of other pro-coagulant interventions—included if measured from the start of surgery, defined a priori and measured equally in both groups. We will use follow-up that is closest to including 24 h after the end of surgery. | Categorical | Relative risk | |
13. Tranexamic acid | |||
14. Recombinant Factor VIIa | |||
15. Other recombinant factor concentrates | |||
16. Serious complications associated with blood loss and blood product transfusion—included if measured from the start of surgery, defined a priori and measured equally in both groups. We will use follow-up that is closest to including 24 h after the end of surgery. - Unplanned intensive care unit (ICU) admission <24 h - Myocardial infarction (MI) <7 days - Cardiac arrest <24 h - Central nervous system complications – Cerebrovascular accident (CVA) or traumatic brain injury (TBI) <7 days post-operation - renal complications <7 days—where a clear definition of renal complications has been provided in the paper and measured equally in both groups | Categorical | Relative risk | |
17. Thromboembolic complications—included if measured from the start of surgery, defined a priori and measured equally in both groups. We will use follow-up that is closest to including 7 days after the end of surgery. - New arterial or deep venous thrombosis - Pulmonary embolism | Categorical | Relative risk | |
18. Cost—we will include any cost outcomes from studies where a numerical cost outcome has been clearly defined and equally measured for both groups. | Numerical | Standardised mean difference |