Oliver 2003.
| Study characteristics | ||
| Methods |
Type of study: single‐centre, parallel‐group randomised controlled trial. Full‐text paper Country: United States Dates of trial (start and end): not reported Follow‐up until: 24 hours postoperatively |
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| Participants |
Inclusions: 1. Neonates and infants (age range not defined) undergoing open heart surgery with CPB 2. Weight 10 kg or less Exclusions: 1. Pre‐existing haematological disease 2. Abnormal pre‐operative clotting parameters 3. Severe liver failure 4. Blood transfusion in 24 hours before operation Age: Intervention arm: mean 6.9 months (standard deviation 7.4 months) Comparator arm: mean 6.6 months (standard deviation 5.9 months) Ethnicity: Not reported Gender: Intervention arm: 17 male and 11 female Comparator arm: 14 male and 14 female Operations: Intervention arm: elective surgery only; 13 non‐cyanotic heart disease and 15 cyanotic heart disease Comparator arm: elective surgery only; 17 non‐cyanotic heart disease and 11 cyanotic heart disease |
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| Interventions |
Intervention arm: Transfusion with 1 unit FFP with CPB priming intra‐operatively (n = 28) Comparator arm: Infusion of 200 ml 5% HAS with CPB priming intra‐operatively (n = 28) |
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| Outcomes |
Primary: Blood loss 24 hours postoperatively Other outcomes: 1. Blood transfusion requirements in operating room and 24 hours postoperatively 2. Bleeding ('wet surgical field') 10 minutes after protamine administration 3. Prothrombin time 10 minutes after protamine administration and on arrival to ICU 4. Activated partial thromboplastin time 10 minutes after protamine administration and on arrival to ICU 5. Fibrinogen concentration 10 minutes after protamine administration 6. Thromboelastography R time 10 minutes after protamine administration 7. Thromboelastography maximum amplitude 10 minutes after protamine administration 8. Return to theatre during study period 9. Perioperative mortality 10. ICU admission duration |
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| Notes | Fibrin glue also used | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomised to receive either 200mL of albumin 5% or one unit FP in the prime for CPB" Comment: how the random sequence was generated is not described |
| Allocation concealment (selection bias) | Unclear risk | Comment: how allocation was concealed is not described. Although the patient had already been recruited to the study at the time of priming the pump, it remains possible that the treating clinician may have been aware of the group to which a patient had been allocated (e.g. visual cues, as the products look different) and may have been able to influence the allocation sequence |
| Blinding of participants | Unclear risk | Participants were neonates and infants and at this young age are likely to be unaware of their random allocation |
| Blinding of personnel | Low risk | Quote: "All personnel associated with the perioperative care of these infants and children except the perfusionists were blinded to the constitution of the prime" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information about blinding of analysts to permit judgement |
| 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 | High risk | Similar numbers of patients undergoing each type of surgery. In addition to the study intervention, patients in the control group were given 0.6 ± 0.7 units FFP whereas those in the FFP group received an additional 0.3 ± 0.5 units FFP. This may confound the outcomes. Cryoprecipitate transfusions were equal in both groups |
| Balance of baseline factors | Low risk | Similar age, weight and co‐morbidities |