Vaginal Hysterectomy
Conditions
Brief summary
This is a randomized control, double-blind study in which women who are about to go an elective vaginal hysterectomy are offered to participate. Patients will be randomly assigned to one of two groups: the tranexamic acid group, in which 1 gram of tranexamic acid (Hexakapron) is administered intravenously before surgery, and the control group, in which patients will receive 10 ml of normal saline 0.9% intravenously.
Detailed description
This is a randomized control, double-blind study in which women who are about to go for an elective vaginal hysterectomy are offered to participate. Patients will be randomly assigned to one of two groups: the tranexamic acid group, in which 1 gram of tranexamic acid (Hexakapron) is administered intravenously before surgery, and the control group, in which patients will receive 10 ml of normal saline 0.9% intravenously. A nurse will prepare the solution according to the randomization and will handle it to the anesthesiologist.
Interventions
DRUGTranexamic acid
One gram of tranexamic acid (Hexakapron) is administered intravenously before surgery
DRUGPlacebo
patients will receive 10 ml of normal saline 0.9% intravenously.
Sponsors
Wolfson Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Randomized control
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
\*Women in general good health (defined as American Society of Anesthesiologists grade 1-2) who are about to undergo elective vaginal hysterectomy indicated by pelvic organ prolapse (POP).
Exclusion criteria
* allergy to TXA * familial or personal history of hypercoagulability disorder or thromboembolic events * impaired renal function or hematuria * patients receiving antithrombotic therapy * additional concurrent abdominal/ laparoscopic procedures * malignancy * Post-assignment exclusion will be executed in cases of conversion to laparotomy/ laparoscopy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean objective assessment of blood loss | Immediately after surgery | Objective assessment of blood loss is calculated by subtraction the weight of used pads after the surgery from the preoperative weight (blood lost during surgery will be absorbed by pads only, without using suction); 1 g of absorbed fluid will be converted to 1 mL of blood. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean subjective blood loss (SBL) | Immediately after surgery | SBL will be estimated by the senior surgeon. |
| Mean difference in hemoglobin levels before and after surgery | One day after surgery | Preoperative and postoperative hemoglobin level difference |
| The number of patients who need blood products transfusion | 30 days after surgery | The need of blood transfusion or other blood products in order to treat excessive blood loss |
| The size of pelvic hematoma after surgery | One day after surgery | Postoperative pelvic hematoma, diagnosed and measured by ultrasound |
Countries
Israel
Contacts
Primary ContactOhad Gluck
Outcome results
None listed