Intervention for Hip Fracture

Phase 3
Waitlist Available
Led By Gregory Tocks, DO
Research Sponsored by Lancaster General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Must not have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up3 months
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial

Study Summary

This trial will compare the effects of tranexamic acid (TXA) versus placebo on blood loss and transfusion requirements in patients over 60 years old who have undergone hip fracture surgery.

Eligible Conditions
  • Hip Fracture

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood Transfusions
Secondary outcome measures
Complication Rate
Hospital Readmission
Mortality Rate

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: InterventionActive Control1 Intervention
100 cc normal saline with 1g of tranexamic acid in solution
Group II: PlaceboPlacebo Group1 Intervention
100 cc normal saline

Find a site

Who is running the clinical trial?

Lancaster General HospitalLead Sponsor
22 Previous Clinical Trials
3,512 Total Patients Enrolled
1 Trials studying Hip Fracture
Gregory Tocks, DOPrincipal Investigator
Penn Medicine / Lancaster General Hospital

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT03923959 — Phase 3
Hip Fracture Research Study Groups: Intervention, Placebo
Hip Fracture Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT03923959 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT03923959 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given the go-ahead to this new method/drug/etc.?

"There is some evidence that the intervention being tested is effective, as well as numerous reports confirming its safety, so our team has given it a score of 3."

Answered by AI

What is the typical reason why a doctor would prescribe Intervention?

"Although hyperfibrinolysis is the primary use case, Intervention is also effective for treating other conditions like hemophilia, bleeding, and tooth extractions."

Answered by AI

Are new volunteers being sought for this experiment?

"The clinicaltrials.gov website indicates that this trial is not presently looking for participants. This particular trial was first posted on February 1st, 2020 and was last updated on October 25th, 2022. There are 455 other trials that are actively recruiting patients."

Answered by AI

Is Intervention a common medical procedure?

"At the moment, 69 clinical trials studying Intervention are ongoing. Among these, 29 are in Phase 3. Many of the studies for Intervention are based in Kansas City, Kansas; however, 305 locations across the globe are running trials for this treatment."

Answered by AI
Recent research and studies
European Journal of Cardio-Thoracic SurgeryJournal
Tranexamic Acid and Aprotinin in Low- and Intermediate-risk Cardiac Surgery: A Non-sponsored, Double-blind, Randomised, Placebo-controlled Trial☆
Later, Alexander F.L., Jacinta J. Maas, Frank H.M. Engbers, Michel I.M. Versteegh, Eline F. Bruggemans, Robert A.E. Dion, and Robert J.M. Klautz. 2009. “Tranexamic Acid and Aprotinin in Low- and Intermediate-risk Cardiac Surgery: A Non-sponsored, Double-blind, Randomised, Placebo-controlled Trial☆”. European Journal of Cardio-thoracic Surgery. Oxford University Press (OUP). doi:10.1016/j.ejcts.2008.11.038.
The Journal of ArthroplastyJournal
The Efficacy of Tranexamic Acid in Total Hip Arthroplasty: A Network Meta-analysis
Fillingham, Yale A., Dipak B. Ramkumar, David S. Jevsevar, Adolph J. Yates, Peter Shores, Kyle Mullen, Stefano A. Bini, et al.. 2018. “The Efficacy of Tranexamic Acid in Total Hip Arthroplasty: A Network Meta-analysis”. The Journal of Arthroplasty. Elsevier BV. doi:10.1016/j.arth.2018.06.023.
Acta Orthopaedica ScandinavicaJournal
Tranexamic Acid, Given at the End of the Operation, Does Not Reduce Postoperative Blood Loss in Hip Arthroplasty
Benoni, Göran, Stefan Lethagen, Paul Nilsson, and Hans Fredin. 2000. “Tranexamic Acid, Given at the End of the Operation, Does Not Reduce Postoperative Blood Loss in Hip Arthroplasty”. Acta Orthopaedica Scandinavica. Medical Journals Sweden AB. doi:10.1080/000164700317411834.
Journal of Bone and Joint SurgeryJournal
Topical (intra-articular) Tranexamic Acid Reduces Blood Loss and Transfusion Rates Following Total Hip Replacement
Alshryda, Sattar, James Mason, Praveen Sarda, Antoni Nargol, Nick Cooke, Hafeez Ahmad, S. Tang, et al.. 2013. “Topical (intra-articular) Tranexamic Acid Reduces Blood Loss and Transfusion Rates Following Total Hip Replacement”. Journal of Bone and Joint Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.l.00908.
~86 spots leftby Oct 2024
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