Chong Sung 2006.
| Study characteristics | ||
| Methods |
Type of study: single‐centre, parallel‐group randomised controlled trial. Full‐text paper Country: South Korea Dates of trial (start and end): June 2003 to January 2004 Follow‐up until: 24 hours postoperatively |
|
| Participants |
Inclusions: 1. Children (6 months to 10 years) undergoing elective cardiac surgery with CPB Exclusions: 1. Renal failure 2. Abnormal pre‐operative clotting parameters 3. Infants (> 6 months) undergoing cardiac surgery Age: Intervention arm: median 24 months (range 6 to 120 months) Comparator arm: median 24 months (range 6 to 72 months) Ethnicity: Not reported Gender: Not reported Operations: Intervention arm: elective surgery only; 21 non‐cyanotic heart disease and 0 cyanotic heart disease Comparator arm: elective surgery only; 19 non‐cyanotic heart disease and 2 cyanotic heart disease |
|
| Interventions |
Intervention arm: Transfusion of 10 ml/kg FFP after CPB and heparin neutralisation (n = 21) Comparator arm: Infusion of 10 ml/kg hydroxyethyl starch (HES) 130/0.4 after CPB and heparin neutralisation) (n = 21) |
|
| Outcomes |
Primary: Blood loss at 24 hours postoperatively Other outcomes: 1. Red cell transfusion requirements 24 hours postoperatively 2. INR immediately after transfusion of FFP or HES and at 24 hours postoperatively 3. APTT immediately after transfusion of FFP or HES and at 24 hours postoperatively 4. Haematocrit immediately after transfusion of FFP or HES 5. Return to theatre within 24 hours postoperatively 6. Mortality (time period not stated) |
|
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Study subjects received either 10mL/kg FFP ...or HES ...in a random manner shortly after protamine infusion." How the random sequence was generated is not described |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information about allocation concealment to permit judgement |
| Blinding of participants | Unclear risk | Insufficient information about blinding of participants to permit judgement |
| 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 | 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 7.3 ± 10.2 ml/kg FFP whereas those in the FFP group received an additional 3.8 ± 7.1 ml/kg FFP. This may confound the outcomes |
| Balance of baseline factors | Low risk | Similar age groups and body weight of participants |