An interventional study of Tranexamic acid and Placebo in Vaginal Hysterectomy, sponsored by Wolfson Medical Center. Status unknown at 1 site in Israel. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by Wolfson Medical Center · Not applicable, Interventional, and Supportive care
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.
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.
Wolfson Medical Center is the lead sponsor of 118 studies on the registry; 17 are open to participants now.
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*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:
One gram of tranexamic acid (Hexakapron) is administered intravenously before surgery.
Drug: Tranexamic acid
patients will receive 10 ml of normal saline 0.9% intravenously.
Drug: Placebo
One gram of tranexamic acid (Hexakapron) is administered intravenously before surgery
Also known as: Hexakapron
patients will receive 10 ml of normal saline 0.9% intravenously.
Also known as: Normal Selaine 0.9%
Mean objective assessment of blood loss
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.
Time frame: Immediately after surgery
Mean subjective blood loss (SBL)
SBL will be estimated by the senior surgeon.
Time frame: Immediately after surgery
Mean difference in hemoglobin levels before and after surgery
Preoperative and postoperative hemoglobin level difference
Time frame: One day after surgery
The number of patients who need blood products transfusion
The need of blood transfusion or other blood products in order to treat excessive blood loss
Time frame: 30 days after surgery
The size of pelvic hematoma after surgery
Postoperative pelvic hematoma, diagnosed and measured by ultrasound
Time frame: One day after surgery
This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tranexamic Acid