Långström 2008.
| Study characteristics | ||
| Methods | Type of study: single‐centre, parallel‐group randomised controlled trial. Full‐text paper Dates of trial (start and end): not reported Follow‐up until: 30 days postoperatively | |
| Participants |
Inclusions:
Neonates (aged less than 1 month) undergoing open heart surgery with CPB
Exclusions:
Infusions other than red blood cells or crystalloid in the 2 hours postoperatively before FFP or human albumin solution (HAS) been given Age: All patients aged less than 1 month but not reported separately for each arm of study Ethnicity: Not reported Gender: Not reported Operations: 10 non‐cyanotic heart disease. Not reported separately for each arm of the study |
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| Interventions | Intervention arm: Transfusion of 20 ml/kg FFP on admission to ICU postoperatively (n = 9) Comparator arm: Transfusion of 20 ml/kg 4% HAS on admission to ICU postoperatively (n = 8) | |
| Outcomes |
Primary:
Prothrombin fragments 1 + 2 post‐infusion and 2 hours postoperatively
Other outcomes:
1. Mortality within 30 days postoperatively 2. Thromboembolism within 30 days postoperatively 3. Overt bleeding within 30 days postoperatively 4. Thrombin‐antithrombin complexes post‐infusion and 2 hours postoperatively 5. D‐dimers post‐infusion and 2 hours postoperatively |
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| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information about the sequence generation process to permit judgement |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information about allocation concealment to permit judgement |
| Blinding of participants | Low risk | Neonates (aged < 1 month) will be unaware of allocation |
| Blinding of personnel | Unclear risk | Insufficient information about blinding of personnel to permit judgement |
| 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 | 2 patients were excluded after randomisation. This was pre‐specified in the protocol |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported |
| Equal use of co‐interventions in each arm | Low risk | Quote: "Aprotinin (30,000 IU/kg to the prime, 30,000 IU/kg as a bolus to the patient 1 h after the induction of anesthesia, and a steady infusion of 8,000 IU/kg/h during CPB) was administered to all patients." "All patients received 200 IU prothrombin complex concentrate (PCC, Prothromblex‐T TIM 4, Baxter, Vienna, Austria) after protamine." |
| Balance of baseline factors | Unclear risk | Insufficient information about baseline factors to permit judgement |