Caglar 2008.
Methods | Single centre study Patients were randomised according to a computer‐generated sequence Participants allocated into groups by sequentially numbered drug containers of identical appearance Patients, surgeons and anaesthesiologists were blinded Power calculation: performed No losses to follow up and all patients were analysed in the group in which they were allocated No details given about the source of funding |
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Participants | Setting: Ankara Etlik Maternity and Women's Health Teaching Research Hospital, Ankara, Turkey Inclusion criteria: participants were women scheduled for myomectomy due to myoma uteri Exclusion criteria: patients with malignancy, history of thromboembolic disease, ischaemic heart disease, subarachnoidal bleeding, hematuria, and body mass index >30 were excluded n = 100 Age: mean age of the patients was 35.3 ± 5 years (range 23 to 40) Ethnicity: not described Total volume of myomas: 457cm3 (SD = 669) in the intervention group and 286cm3 (SD = 259) in the control group |
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Interventions | Treatment arm (n = 50): a bolus intravenous injection of tranexamic acid (a medication that prevents bleeding by inhibiting the breakdown of blood clots) 10mg/kg (maximum 1g) 15 min before incision followed by continuous infusion of 1mg/kg/h dissolved in 1 L of saline for 10 h (maximum 1 g/10 h) Control arm (n = 50): a bolus injection of placebo (saline of similar volume to tranexamic acid) 15 min before incision followed by continuous infusion of 1 L of saline for 10 h Type of operation: laparotomy |
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Outcomes | Perioperative blood loss, postoperative blood loss, total blood loss, duration of surgery, postoperative haemoglobin, postoperative haematocrit, blood transfusion requirements on ward | |
Notes | Authors contacted No significant difference in the baseline characteristics such as age, body mass index, bleeding time, coagulation time, prothrombin time, the number and volume of myomas removed between the intervention and control groups |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Patients were randomised according to a computer‐generated sequence |
Allocation concealment (selection bias) | Low risk | Participants allocated into groups by sequentially numbered drug containers of identical appearance |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No incomplete outcome data |
Selective reporting (reporting bias) | Unclear risk | We do not have access to the study protocol |
Other bias | Low risk | No other sources of bias identified |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and personnel were blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were blinded |