Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-03-01 @ 3:58 PM
Study NCT ID:
NCT03923959
Status:
COMPLETED
Last Update Posted:
2024-10-10
First Post:
2019-04-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of TXA Prior to Surgery in the Geriatric Hip Fracture Population
Sponsor:
Lancaster General Hospital
Organization:
Study Overview
Official Title:
Evaluation of Tranexamic Acid Prior to Surgery in the Geriatric Hip Fracture Population for the Reduction of Post-Operative Blood Transfusion
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAHFT
Brief Summary:
The overall design of the study is a prospective, double-blinded, randomized study in the geriatric hip fracture population comparing those who receive intravenous tranexamic acid prior to incision to those who receive a placebo.
Detailed Description:
A significant portion of the geriatric hip fracture population have comorbidities including chronic kidney disease, congestive heart failure, ischemic heart disease, stroke, etc. These patients may be anemic prior to the surgery, and are at increased risk for further blood loss as a result of the fracture and surgical operation. However, intra-operative or post-operative blood transfusions also increase the risk of renal and cardiac complications in this population.
Tranexamic acid (TXA) is an anti-fibrinolytic medication that has transformed total joint replacement management regarding blood loss prevention. Geriatric patients requiring emergent hip fracture repair may significantly benefit from routine administration of TXA prior to the procedure to decrease the risk of blood loss. Thus, treatment may further reduce the percentage of patients who experience blood transfusions and complications associated with transfusions.
The investigators will examine if administration of TXA prior to incision in the geriatric hip fracture patient population decreases the risk of intra-operative or post-operative blood transfusions compared to placebo.
Tranexamic acid (TXA) is an anti-fibrinolytic medication that has transformed total joint replacement management regarding blood loss prevention. Geriatric patients requiring emergent hip fracture repair may significantly benefit from routine administration of TXA prior to the procedure to decrease the risk of blood loss. Thus, treatment may further reduce the percentage of patients who experience blood transfusions and complications associated with transfusions.
The investigators will examine if administration of TXA prior to incision in the geriatric hip fracture patient population decreases the risk of intra-operative or post-operative blood transfusions compared to placebo.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: