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. 2014 Aug 15;2014(8):CD005355. doi: 10.1002/14651858.CD005355.pub5

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
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
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
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
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