Paniagua 2011.

Methods	Only published as conference abstract, stopped before completion due to slow inclusion. Have unpublished data on 44 patients (planned for 100 patients) Two‐group parallel RCT, one centre ITT: no. 52 patients were randomized: 24 patients in control group and 28 in the intervention group. But 6 patients in control group and 2 patients in the intervention were excluded from analysis due to patients having received off‐pump surgery or did not fulfil the criteria of excessive bleeding Funding: not for profit Overall study quality: high risk of bias Sample size calculation was reported in protocol (additional information from authors)
Participants	Inclusion criteria: adult patients undergoing cardiac surgery and with trial consent given before surgery were randomized if: • they presented diffuse bleeding after protamine and/or • they bled excessively after surgery. With criteria for excessive bleeding: the mediastinal chest tube drainage ≥ 300 mL in the first hour after surgery; ≥ 250 mL in the second hour or ≥ 150 mL at any later time. "Bleeding stopped" was defined as mediastinal chest tube drainage < 150 mL/hour Exclusion criteria: • patients ≤ 18 years • surgery without cardiopulmonary bypass • surgery with mini extracorporeal circulation • refuse to participate in the study
Interventions	Intervention group: ROTEM‐guided transfusion algorithm, (n = 26). Hypofibrinogenemia was diagnosed if MCF in EXTEM < 50 and in FIBTEM < 9 and thrombocytopenia if MCF in EXTEM < 50 and in FIBTEM ≥ 9 Control group: routine transfusion therapy based on standard laboratory coagulation testing, (n = 18). Hypofibrinogenaemia was diagnosed if fibrinogen (Clauss method) < 1 g/L and thrombocytopenia if platelet count is below 80x109/L Duration of intervention: peri‐ and postoperative algorithm (until patient stops bleeding (mediastinal chest tube drainage bellow 150 mL/hour))
Outcomes	Primary: the number of transfused units of packed red blood cells during the period between inclusion into the study and after mediastinal chest tube drainage was < 150 mL/hour (stops bleeding) Secondary: the number of transfused units of FFP, platelet concentrates and any other administered haemostatic therapy during the period between inclusion into the study and after mediastinal chest tube drainage was < 150 mL/hour ( stops bleeding) Postoperative chest tube blood loss (until chest tube withdrawal, during acute bleeding and at 24 hours after ICU admission) Mortality during hospital stay. No data on adverse events
Notes	Country: Spain. Language: English Letter sent to authors on 18 December 2015. Reply received 19 December 2015. Additional information provided by author. A total of 13 in control group and 8 in ROTEM group had chronic kidney disease at baseline, defined as a creatinine clearance of less than 60 mL/min/m2before the operation. Ten patients had pre‐existing thrombocytopenia Follow‐up: until stopped bleeding for primary outcome and until discharge on mortality. No patients lost to follow‐up Authors conclusion:"Our objective is to include 100pts in order to archive statistical significance, but in this preliminary analysis we have already seen a clear tendency towards reduction in need of RBC and FFP transfusion.The reduction of platelet transfusion and total bleeding time reached statistical significant levels" Wound infection as outcome was insignificant with one case in each group
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated.
Allocation concealment (selection bias)	Low risk	Sealed envelopes.
Blinding (performance bias and detection bias) All outcomes	High risk	Only participants were blinded.
Incomplete outcome data (attrition bias) All outcomes	High risk	No patients were lost to follow‐up but no ITT analysis ‐ Authors description: "We actually randomized 52 patients in both groups: 24 patients in control group and 28 in the intervention group. Unfortunatelly when we start to analyze data we realized that 6 patients in control group and 2 patients in the intervention group didn’t meet inclusion criteria. Reasons for exclusion were: patients had received off‐pump surgery or didn’t fulfil the criteria of excessive bleeding laid down in the protocol" Terminated before time due to slow inclusion.
Selective reporting (reporting bias)	Low risk	Clinical trials registration: NCT01919840. Appears free of selection bias.
Other bias	Low risk	Funding: not for profit. Apears free of other biases.