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Recruiting NCT04760301

Local Tranexamic Acid During Vaginal Hysteractomy to Reduce Blood Loss

No phase Interventional Blood Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: local tranexamic acid injection, local normal saline injection to cervix.
Who it may be relevant to
Registry conditions: Blood Loss. Basic parameters: 20 years — 90 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Local Tranexamic Acid During Vaginal Hysterectomy to Reduce Blood Loss

Overview

Assessing the efficiency of Prophylactic use of local tranexamic acid during vaginal hysterectomy to reduce blood loss during operation

Detailed description

This randomized control trial will investigate whether local tranexamic acid is efficient for decreasing bleeding during vaginal hysterectomy.

The investigators will randomize local placebo (saline) vs. local 1 gr tranexamic acid; local 1gr tranexamic acid diluted in 10 ml saline and local 10 ml saline at the beginning of surgery.

Interventions

  • Drug local tranexamic acid injection
    local tranexamic acid injection to cervix- 1 g tranexamic acid diluted in 10 ml saline
  • Other local normal saline injection to cervix
    local normal saline injection to the cervix- 20 ml saline

Primary outcome measures

  • Blood loss during operation - measure in ml [Time frame: End of surgery]

Eligibility criteria

Inclusion criteria

  • 20-90 years old female patients going through vaginal hysterctomy

Exclusion criteria

  • massive bleeding during operation due to major vessles injury
  • known coagulopathies
  • sensitivity to tranexamic acid
  • medical need in tranexamic acid administration during operation due to bleeding

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Single group
Masking
Double blind
Primary purpose
Prevention

Study locations

Israel · 2 centers
  • Meir Medical Center — Kfar Saba
  • Meir medical center — Kfar Saba

Identifiers

NCT: NCT04760301 · 0354-19-MMC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗