Wilhelmi 2001.
| Study characteristics | ||
| Methods |
Type of study: single‐centre randomised controlled trial. Full‐text paper Country: Germany Dates of trial (start and end): September 2007 to April 2008 Follow‐up until: 24 hours postoperatively |
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| Participants |
Inclusions: 1. Adults undergoing cardiac surgery with coronary artery bypass surgery (with or without CPB) Exclusions: 1. Previous cardiac surgery procedures 2. Antiplatelet agents in 72 hours prior to surgery 3. Known coagulation disorders 4. Left ventricular ejection fraction < 40% Age: Intervention arm: mean 63 years (standard deviation 8 years) Comparator arm: mean 65 years (standard deviation 7 years) Ethnicity: Not reported Gender: Intervention arm: 43 male and 17 female Comparator arm: 44 male and 16 female Operations: Intervention arm: 60 elective coronary artery bypass grafts with CPB Comparator arm: 58 elective coronary artery bypass grafts with CPB and 2 emergency coronary artery bypass grafts with CPB |
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| Interventions |
Intervention arm: Transfusion of 4 units (1000 ml) FFP after CPB and heparin neutralisation (n = 60) Comparator arm: Transfusion of 1000 ml hydroxyethyl starch (HES) after CPB and heparin neutralisation (n = 60) |
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| Outcomes |
Primary: Not stated Other outcomes: 1. Postoperative blood loss after 6 and 24 hours 2. Haematocrit on admission to ICU and 24 hours postoperatively 3. Prothrombin time on admission to ICU; 3, 6 and 24 hours after transfusion of FFP or HES; and on discharge from hospital 4. Activated partial thromboplastin time on admission to ICU; 3, 6 and 24 hours after transfusion of FFP or HES; and on discharge from hospital 5. Mortality up to day 9 6. Return to theatre during admission 7. ICU admission duration 8. Red cell transfusions during hospital admission |
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| Notes | Block randomisation. All patients treated with FFP operated on first, followed by control group. 4 units (1000 ml) FFP given in either arm if excessive bleeding postoperatively | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Quote: "Patients were block‐randomised into groups of n = 60 patients. All patients in the FFP group were operated on first, followed by the 60 control patients." |
| Allocation concealment (selection bias) | High risk | Not concealed, as FFP group were all operated on first |
| Blinding of participants | High risk | Not blinded, as FFP group were all operated on first |
| Blinding of personnel | High risk | Not blinded, as FFP group were all operated on first |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Not blinded, as FFP group were all operated on first |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All patients analysed |
| Selective reporting (reporting bias) | Low risk | All pre‐reported outcomes analysed |
| Equal use of co‐interventions in each arm | Low risk | Operations and techniques similar in both groups with the same 2 surgeons performing all the operations. Additional FFP could be given to both groups but the mean volumes given to both groups were substantially different (4 units in FFP group and 0.2 units in control group) |
| Balance of baseline factors | Low risk | Similar age, gender, rates of pre‐operative infarction and pulmonary function tests in both groups |
APTT: activated partial thromboplastin time CPB: cardiopulmonary bypass FFP: fresh frozen plasma HAS: human albumin solution HBV: hepatitis B HES: hydroxyethyl starch ICU: intensive care unit INR: international normalised ratio PT: prothrombin time