Do Patients Who Received Tranexamic Acid in Vaginal Hysterectomy Loose Les Blood, Comparing to Patients Who Did Not?

Study Overview
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Brief Summary
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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
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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.

Official Title
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Do Patients Who Are Treated With Tranexamic Acid Loose Les Blood, Comparing to Patients Who Are Not Treated, During Vaginal Hysterectomy? a Randomized Control Study

Conditions
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Vaginal Hysterectomy

Intervention / Treatment
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* Drug: Tranexamic acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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, or malignancy. Post-assignment exclusion will be executed in cases of conversion to laparotomy/ laparoscopy.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tranexamic acid arm<br>One gram of tranexamic acid (Hexakapron) is administered intravenously before surgery. | Drug: Tranexamic acid<br>* One gram of tranexamic acid (Hexakapron) is administered intravenously before surgery<br>* Other names: Hexakapron;|
| Placebo Comparator: Placebo arm<br>patients will receive 10 ml of normal saline 0.9% intravenously. | Drug: Placebo<br>* patients will receive 10 ml of normal saline 0.9% intravenously.<br>* Other names: Normal Selaine 0.9%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Immediately after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean subjective blood loss (SBL) | SBL will be estimated by the senior surgeon. | Immediately after surgery | 
| Mean difference in hemoglobin levels before and after surgery | Preoperative and postoperative hemoglobin level difference | 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 | 30 days after surgery | 
| The size of pelvic hematoma after surgery | Postoperative pelvic hematoma, diagnosed and measured by ultrasound | One day after surgery |