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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03606109
Other study ID # 18-00535
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 26, 2018
Est. completion date June 2, 2021

Study information

Verified date August 2022
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing high tibial osteotomy (HTO) and tibial tubercle osteotomy (TTO) to minimize hemarthrosis within the knee joint and post operative pain and swelling.


Description:

Not Provided


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date June 2, 2021
Est. primary completion date June 2, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Patients undergoing TTO - Age 18-60 - Willing and able to provide consent Exclusion Criteria: - Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.) - Younger than 18 years of age - Older than 60 years of age - Any patient considered a vulnerable subject - Have bleeding or clotting disorder - Preoperative anticoagulation therapy - Abnormal coagulation profile - Renal disorder or insufficiency - Sickle cell disease

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tranexamic Acid (TXA)
One gram of intravenous tranexamic acid (TXA) will be administrated before tourniquet inflation and before closure of the incision, as 1 g has been shown to be a safe amount with minimal side effects

Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perioperative Blood Loss Perioperative, up to 2 hours
Secondary Score on Visual Analogue Scale (VAS) for Pain VAS will be used to report post-operative pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain. Day 1
Secondary Score on Visual Analogue Scale (VAS) for Pain VAS will be used to report post-operative pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain. Day 4
Secondary Score on Visual Analogue Scale (VAS) for Pain VAS will be used to report post-operative pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain. Day 7
See also
  Status Clinical Trial Phase
Recruiting NCT05759039 - SHould You transFer the Tubercle? N/A