Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02580227
Other study ID # 15-021
Secondary ID
Status Recruiting
Phase Phase 4
First received October 5, 2015
Last updated October 27, 2015
Start date June 2015
Est. completion date March 2017

Study information

Verified date October 2015
Source Good Samaritan Regional Medical Center, Oregon
Contact Stefan Yakel, DO
Phone 541-768-4810
Email styakel@samhealth.org
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate the effect of Tranexamic Acid (TXA) on blood loss and need for perioperative blood transfusion following intertrochanteric and subtrochanteric femur fractures. TXA is a antifibrinolytic medication that prevents the breakdown of blood clots by inhibiting the activation of plasminogen to plasmin in the coagulation cascade. Our hypothesis is that by providing TXA at the time of hospital admission it will decrease the amount of preoperative and intraoperative bleeding thereby leading to a decreased need for post-operative transfusion. This a double blinded, placebo controlled, therapeutic trial in which half of patients will be randomized to receive TXA at the time of hospital admission and half of patients will receive a placebo.


Description:

Tranexamic Acid has a long and proven history of clinical safety and effectiveness in the Orthopaedic literature. Its use in perioperative blood management in total joint arthroplasty is wide spread and is quickly becoming a standard of care. However, evidence on the effectiveness of TXA in lower extremity fracture care is more limited. There is a logical expectation that the use of TXA in lower extremity fracture care will provide a similar benefit in minimizing blood loss and reducing transfusion requirements, based on TXA's success in total joint arthroplasty, however this has not yet been validated in the literature. This study will seek to evaluate the effectiveness of TXA in perioperative blood management within a subset of lower extremity fracture, specifically intertrochanteric femur fractures. Hip fractures represent a common orthopedic injury in a fragile patient population that often necessitates post-operative blood transfusion thereby putting the patient at additional risk of complications. Intertrochanteric femur fractures have an increased risk of post-operative blood transfusion when compared to femoral neck fractures. It is presumed that the difference in blood loss between these two fracture types is caused by increased pre-operative bleeding of intertrochanteric fractures secondary to the extracapsular nature of the fracture, as opposed to a tamponade effect that occurs with intracapsular femoral neck fractures. It can therefore be expected that the use of TXA in intertrochanteric femur fractures will decrease perioperative bleeding leading to a decrease in total blood loss and a decrease in transfusion rates.

Limited research has shown that TXA is effective in reducing perioperative blood loss in hip fracture when compared to placebo, but not as effectively as when used in joint arthroplasty. One explanation for this difference is that TXA is circulating at the time of iatrogenic fracture in total joint arthroplasty or given shortly after, whereas intraoperative TXA administration in hip fractures usually doesn't occur until 6-48 hours after the initial injury. Administering TXA at the time of hospital admission in intertrochanteric femur fracture allows the drug time to decrease blood loss resulting from the fracture as well as the subsequent surgical intervention.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date March 2017
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients sustaining a closed intertrochanteric femur fracture presenting to the Good Samaritan Regional Medical Center.

- Patients who are willing and able to consent to participate in the study

- >18 years of age

Exclusion Criteria:

- Patients with an allergy to tranexamic acid.

- History of thromboembolic event (pulmonary embolism, cerebral vascular accident, deep venous thrombosis),

- History of renal impairment (Cr > 1.5 or glomerular filtration rate < 30)

- Coronary stents

- History of hypercoagulability (Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant).

- Color blindness

- Subarachnoid hemorrhage

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention


Intervention

Drug:
Tranexamic Acid
All subjects will be given 1g of TXA in 100cc normal saline, or placebo of 100cc normal saline at time of admission, after consent is given.
Other:
Placebo
All subjects will be given 1g of TXA in 100cc normal saline, or placebo of 100cc normal saline at time of admission, after consent is given.

Locations

Country Name City State
United States Good Samaritan Hospital Corvallis Corvallis Oregon

Sponsors (1)

Lead Sponsor Collaborator
Good Samaritan Regional Medical Center, Oregon

Country where clinical trial is conducted

United States, 

References & Publications (4)

Desai SJ, Wood KS, Marsh J, Bryant D, Abdo H, Lawendy AR, Sanders DW. Factors affecting transfusion requirement after hip fracture: can we reduce the need for blood? Can J Surg. 2014 Oct;57(5):342-8. — View Citation

Kadar A, Chechik O, Steinberg E, Reider E, Sternheim A. Predicting the need for blood transfusion in patients with hip fractures. Int Orthop. 2013 Apr;37(4):693-700. doi: 10.1007/s00264-013-1795-7. Epub 2013 Feb 5. — View Citation

Vijay BS, Bedi V, Mitra S, Das B. Role of tranexamic acid in reducing postoperative blood loss and transfusion requirement in patients undergoing hip and femoral surgeries. Saudi J Anaesth. 2013 Jan;7(1):29-32. doi: 10.4103/1658-354X.109803. — View Citation

Zufferey PJ, Miquet M, Quenet S, Martin P, Adam P, Albaladejo P, Mismetti P, Molliex S; tranexamic acid in hip-fracture surgery (THIF) study. Tranexamic acid in hip fracture surgery: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):23-30. doi: — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Calculated Blood Loss Admission to discharge, 3-4 days on average. Yes
Other Length of Stay Admission to discharge, 3-4 days on average. No
Other Myocardial Infarction Admission to discharge, 3-4 days on average. Yes
Other Deep Venous Thrombosis Admission to discharge, 3-4 days on average. Yes
Other Pulmonary Embolism Admission to discharge, 3-4 days on average. Yes
Other Cerebrovascular Accident Admission to discharge, 3-4 days on average. Yes
Other Surgical Site Infection Rate Admission to discharge, 3-4 days on average. Yes
Primary Perioperative Blood Loss Perioperative blood loss measured by serial hemoglobin and hematocrit Admission to discharge, 3-4 days on average. Yes
Primary Blood Transfusion Rates Admission to discharge, 3-4 days on average. Yes
See also
  Status Clinical Trial Phase
Completed NCT02507609 - Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium N/A
Completed NCT03906864 - Care Pathway for Sub-acute Hip Rehabilitation N/A
Recruiting NCT04063891 - Vibration Therapy as an Intervention for Enhancing Trochanteric Hip Fracture Healing in Elderly Patients N/A
Completed NCT05039879 - Life Improving Factors After a Hip Fracture
Not yet recruiting NCT03887494 - Study of the Impact of the Femoral Implant "Y-strut" on Lytic Bone Metastases of the Femoral Neck (WAZA-ARY) N/A
Terminated NCT03065101 - Trigen InterTAN vs Sliding Hip Screw RCT N/A
Completed NCT03695081 - Patient Pathway Pharmacist - Optimal Drug-related Care N/A
Completed NCT03545347 - Physiotherapy, Nutritional Supplement and Anabolic Steroids in Rehabilitation of Patients With Hip Fracture. Phase 2
Recruiting NCT05971173 - Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery Early Phase 1
Active, not recruiting NCT04957251 - Anterior vs Posterior Approach for Hip Hemiarthroplasty N/A
Terminated NCT04372966 - Uncemented Versus Cemented Total Hip Arthroplasty for Displaced Intracapsular Hip Fractures N/A
Withdrawn NCT05030688 - Fascia Iliaca Compartment Block and PENG Block for Hip Arthroplasty N/A
Completed NCT04424186 - 'Rehabilitation for Life' N/A
Not yet recruiting NCT04183075 - Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture N/A
Withdrawn NCT05518279 - Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures Phase 3
Not yet recruiting NCT02892968 - ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients N/A
Not yet recruiting NCT02223572 - Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture N/A
Active, not recruiting NCT02247791 - Uncemented Compared to Cemented Femoral Stems in Total Hip Arthroplasty N/A
Completed NCT00746876 - Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures. N/A
Completed NCT00058864 - The HIP Impact Protection Program (HIP PRO) N/A