Blood Loss After Early TXA in Hip Fractures.
Primary Purpose
Hip Fractures
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tranexamic acid
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures focused on measuring tranexamic acid, TXA, hip fracture
Eligibility Criteria
Inclusion Criteria:
- Femoral neck, intertrochanteric, subtrochanteric femur fracture
- Age >18
- Undergoing surgical stabilization or arthroplasty by any method as determined by attending surgeon
Exclusion Criteria:
- Age <18
- Concomitant fracture
- Preoperative anemia needing blood transfusion before surgery
- Severe comorbidity (active cancer, severe pulmonary disease, ESRD)
- Allergy for tranexamic acid
- History of acute thromboembolic event (Deep Vein Thrombosis, Pulmonary Embolism, Stroke, TIA) in the previous 12 months
- Myocardial infarction in the previous 12 months
- Renal function impairment (creatinine clearance <30 mL/min), or kidney transplant
- History of hypercoagulability (Factor V Leiden, Protein C/S deficiency)
Sites / Locations
- Community Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Early TXA
Control
Arm Description
Experimental group will receive 10 mg/kg IV TXA while in the Emergency Department, and repeat preoperative and postoperative doses.
Control group will receive 100 mL 0.9% normal saline in the Emergency Department, and 10 mg/kg IV TXA before skin incision and again in post anesthesia care unit.
Outcomes
Primary Outcome Measures
Change in calculated and recorded hemoglobin
Change in hemoglobin (blood loss) will be assessed based on preoperative blood draw and blood draws post op and on each inpatient day during hospitalization.
Total postoperative units of red blood cell transfusion
The number of units of RBC transfusions will be recorded and compared between treatment and placebo groups.
Secondary Outcome Measures
VTE
DVT or PE
Infection
Superficial and deep infections
Readmission
30 day readmission
Other complications
Any additional unforeseen complications
Full Information
NCT ID
NCT04488367
First Posted
July 16, 2020
Last Updated
July 18, 2022
Sponsor
Community Memorial Health System
1. Study Identification
Unique Protocol Identification Number
NCT04488367
Brief Title
Blood Loss After Early TXA in Hip Fractures.
Official Title
The Effects of the Timing of Tranexamic Acid Administration on Blood Loss in Hip Fractures.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Community Memorial Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Our present study aims to initiate TXA administration immediately upon diagnosis of hip fracture in the Emergency Department. This will be a single blind randomized controlled trial comparing early administration of TXA in the ED in addition to perioperative dosing versus the standard perioperative administration only. The study population will include patients who have sustained a femoral neck, intertrochanteric, or subtrochanteric femur fracture and are undergoing surgical internal fixation or arthroplasty. We will prospectively compare the need for blood transfusion, total and hidden blood loss, postoperative complications, length of stay and readmission within 30 days.
Detailed Description
Consent will be obtained for study enrollment from the patient or legal decision maker. The patient will then be randomized and stratified based on the fracture type, fixation method anticipated, and presence of anticoagulation.
Treatment drug and saline placebo will be blinded from the patient. Treatment arm patients will receive a dose of 10 mg/kg of TXA IV as soon as possible in the ED. They will then receive repeat doses prior to skin incision and again after the end of surgery. Control group will receive a placebo dose of normal saline in the ED and then the standard 10 mg/kg TXA doses prior to surgery and again after the end of surgery. The perioperative doses will not be blinded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
tranexamic acid, TXA, hip fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early TXA
Arm Type
Experimental
Arm Description
Experimental group will receive 10 mg/kg IV TXA while in the Emergency Department, and repeat preoperative and postoperative doses.
Arm Title
Control
Arm Type
Other
Arm Description
Control group will receive 100 mL 0.9% normal saline in the Emergency Department, and 10 mg/kg IV TXA before skin incision and again in post anesthesia care unit.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
Early TXA
Intervention Description
10 mg/kg IV TXA in the ED, repeat doses before skin incision and in PACU
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
Control Placebo
Intervention Description
100 mL 0.9% normal saline in the ED, 10 mg/kg IV TXA before skin incision and in PACU
Primary Outcome Measure Information:
Title
Change in calculated and recorded hemoglobin
Description
Change in hemoglobin (blood loss) will be assessed based on preoperative blood draw and blood draws post op and on each inpatient day during hospitalization.
Time Frame
From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first.
Title
Total postoperative units of red blood cell transfusion
Description
The number of units of RBC transfusions will be recorded and compared between treatment and placebo groups.
Time Frame
From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first.
Secondary Outcome Measure Information:
Title
VTE
Description
DVT or PE
Time Frame
Postoperative for 30 days
Title
Infection
Description
Superficial and deep infections
Time Frame
Postoperative for 30 days
Title
Readmission
Description
30 day readmission
Time Frame
Within 30 days postoperative
Title
Other complications
Description
Any additional unforeseen complications
Time Frame
Postoperative for 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Femoral neck, intertrochanteric, subtrochanteric femur fracture
Age >18
Undergoing surgical stabilization or arthroplasty by any method as determined by attending surgeon
Exclusion Criteria:
Age <18
Concomitant fracture
Preoperative anemia needing blood transfusion before surgery
Severe comorbidity (active cancer, severe pulmonary disease, ESRD)
Allergy for tranexamic acid
History of acute thromboembolic event (Deep Vein Thrombosis, Pulmonary Embolism, Stroke, TIA) in the previous 12 months
Myocardial infarction in the previous 12 months
Renal function impairment (creatinine clearance <30 mL/min), or kidney transplant
History of hypercoagulability (Factor V Leiden, Protein C/S deficiency)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Allen, DO
Phone
805-948-5100
Email
mallen@cmhshealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Allen, DO
Organizational Affiliation
Resident physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Memorial Hospital
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Allen
Phone
805-948-5100
Email
mallen@cmhshealth.org
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18349013
Citation
Foss NB, Kristensen MT, Kehlet H. Anaemia impedes functional mobility after hip fracture surgery. Age Ageing. 2008 Mar;37(2):173-8. doi: 10.1093/ageing/afm161.
Results Reference
background
PubMed Identifier
27551568
Citation
Praetorius K, Madsen CM, Abrahamsen B, Jorgensen HL, Lauritzen JB, Laulund AS. Low Levels of Hemoglobin at Admission Are Associated With Increased 30-Day Mortality in Patients With Hip Fracture. Geriatr Orthop Surg Rehabil. 2016 Sep;7(3):115-20. doi: 10.1177/2151458516647989. Epub 2016 May 17.
Results Reference
background
PubMed Identifier
20554319
Citation
CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
Results Reference
background
PubMed Identifier
28810918
Citation
Lei J, Zhang B, Cong Y, Zhuang Y, Wei X, Fu Y, Wei W, Wang P, Wen S, Huang H, Wang H, Han S, Liu S, Zhang K. Tranexamic acid reduces hidden blood loss in the treatment of intertrochanteric fractures with PFNA: a single-center randomized controlled trial. J Orthop Surg Res. 2017 Aug 15;12(1):124. doi: 10.1186/s13018-017-0625-9.
Results Reference
background
PubMed Identifier
28031511
Citation
Baruah RK, Borah PJ, Haque R. Use of tranexamic acid in dynamic hip screw plate fixation for trochanteric fractures. J Orthop Surg (Hong Kong). 2016 Dec;24(3):379-382. doi: 10.1177/1602400322.
Results Reference
background
PubMed Identifier
28983887
Citation
Baskaran D, Rahman S, Salmasi Y, Froghi S, Berber O, George M. Effect of tranexamic acid use on blood loss and thromboembolic risk in hip fracture surgery: systematic review and meta-analysis. Hip Int. 2018 Jan;28(1):3-10. doi: 10.5301/hipint.5000556.
Results Reference
background
PubMed Identifier
29426608
Citation
Tian S, Shen Z, Liu Y, Zhang Y, Peng A. The effect of tranexamic acid on hidden bleeding in older intertrochanteric fracture patients treated with PFNA. Injury. 2018 Mar;49(3):680-684. doi: 10.1016/j.injury.2018.01.026. Epub 2018 Feb 2.
Results Reference
background
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Blood Loss After Early TXA in Hip Fractures.
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