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Antifibrinolytic Agent
Tranexamic Acid for Hip Socket Surgery
Phase < 1
Recruiting
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Upper extremity fractures that are non-operative and have no impact on weight-bearing status will be included
Patients with an isolated, closed, posterior wall acetabular fracture managed surgically within 7 days of injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative day 2
Awards & highlights
Study Summary
This trial will evaluate whether the use of tranexamic acid can reduce blood loss in patients undergoing surgery to repair a fracture in their hip socket.
Who is the study for?
This trial is for adults with isolated, closed posterior wall acetabular fractures needing surgery within a week of injury. It's not for those with multiple injuries requiring several surgeries, pre-existing blood clots, bleeding disorders, kidney issues, or who can't consent.Check my eligibility
What is being tested?
The study tests if applying tranexamic acid (TXA) directly to the fracture site before and after surgery affects hemoglobin/hematocrit levels compared to using normal saline in patients with specific hip fractures.See study design
What are the potential side effects?
While the document doesn't specify side effects of TXA in this context, generally it may include risks like nausea, diarrhea, seizures in high doses or allergic reactions. Normal saline typically has minimal risk when used topically.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a non-operative fracture in my arm that doesn't affect my ability to bear weight.
Select...
I had surgery for a specific hip fracture within a week of the injury.
Select...
My bones have stopped growing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ postoperative day 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative day 2
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hematocrit (Hct)
Hemoglobin (Hb)
Side effects data
From 2015 Phase 4 trial • 29 Patients • NCT020630358%
Postoperative wound infection
8%
Postoperative wound infection after release from hospital
8%
Myocardial infaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Tranexamic Acid
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Topical TXA TreatmentExperimental Treatment1 Intervention
2 gm TXA/100 ml of normal saline
Group II: No Topical TreatmentPlacebo Group1 Intervention
Normal saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic Acid
2011
Completed Phase 4
~2740
Find a Location
Who is running the clinical trial?
Foundation for Orthopedic TraumaUNKNOWN
1 Previous Clinical Trials
30 Total Patients Enrolled
University of CincinnatiLead Sponsor
428 Previous Clinical Trials
634,288 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was admitted for injuries to internal organs from a severe accident.I had a blood clot before my surgery.I need several surgeries.I need surgery for other injuries besides my current condition.I have a known bleeding disorder.My bleeding is not caused by a broken hip socket.I am unable to give consent or am unconscious.I have a non-operative fracture in my arm that doesn't affect my ability to bear weight.I have a history of kidney problems.My bones are still growing.I have had a blood clot in my lungs or other parts of my body before.I had surgery for a specific hip fracture within a week of the injury.I have injuries to my legs, pelvis, or spine.My bones have stopped growing.
Research Study Groups:
This trial has the following groups:- Group 1: Topical TXA Treatment
- Group 2: No Topical Treatment
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the upper ceiling of participants for this experiment?
"Affirmative. The information available from clinicaltrials.gov attests to the fact that this research project is currently enrolling participants. It was initially posted on August 25th 2017 and most recently refreshed on May 2nd 2022, with a target of 98 patients across one trial site."
Answered by AI
Does this investigation still accept new participants?
"Yes, according to the data hosted on clinicaltrials.gov, this medical trial is looking for volunteers and was initially posted in August 2017 with its last edit occurring in May 2022. A total of 98 people are required from one site."
Answered by AI
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