The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery
Primary Purpose
Blood Loss Following Open Femur Fracture Surgery
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tranexamic acid (TXA)
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Blood Loss Following Open Femur Fracture Surgery
Eligibility Criteria
Inclusion Criteria:
- Patients admitted to Memorial Hermann Medical Center with acute femur fractures that require open surgical approaches for fracture reduction and implant application, including patients with subtrochanteric, high-energy intertrochanteric, periprosthetic, and intra-articular distal femur fractures.
Exclusion Criteria:
- Preoperative use of any anticoagulant
- History of deep venous thrombosis or pulmonary embolus
- Allergy to TXA
- Hepatic dysfunction (AST/ALT > 60)
- Renal dysfunction (Cr > 1.5 or GFR < 30)
- History of cerebrovascular accident in the past 12 months
- Active coronary artery disease (event in the past 12 months)
- Presence of drug-eluting stent
- Color blindness
- Presence of an additional acute injury that could contribute to blood transfusion requirements
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tranexamic acid (TXA)
Normal saline
Arm Description
Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline.
Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline.
Outcomes
Primary Outcome Measures
Transfusion requirements as assessed by number of packed red blood cell units received
Secondary Outcome Measures
Surgical blood loss as assessed by change in red blood cell volume
Blood loss will be determined using the following calculations:
[Patient's Blood Volume (PBV) = (k1 x Height^3 (m)) + (k2 x Weight (kg)) + k3] (- k1 = 0.3669, k2 = 0.03219, and k3 = 0.6041 for men) (- k1 = 0.3561, k2=0.03308, and k3 = 0.1833 for women)
Multiplying the PBV by the hematocrit (Hct) gives the red blood cell (RBC) volume. As such, a change in the RBC volume can be calculated from a change in the Hct level as follows. PACU is post-anesthesia care unit: [Operative RBC volume loss = PBV x (Day of surgery Hct - PACU Hct)]
If a patient requires an intraoperative transfusion, the calculation will be adjusted as follows:
Operative RBC volume loss = [ [PBV x (Day of surgery Hct - PACU Hct)] +)] + (No. of Units Transfused x 0.285) / (Day of surgery Hct - Post-op Hct) / 2) ]
Surgical blood loss as assessed by an intraoperative cell salvage machine
The intraoperative cell salvage machine allows for a precise estimation of surgical blood loss.
Length of hospital stay
Number of participants with complications
Complications include infection, venous thromboembolic event, and mortality.
Full Information
NCT ID
NCT03679481
First Posted
July 24, 2018
Last Updated
October 14, 2019
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT03679481
Brief Title
The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery
Official Title
The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Withdrawn
Why Stopped
study not started due to lack of funding
Study Start Date
April 1, 2020 (Anticipated)
Primary Completion Date
April 1, 2021 (Anticipated)
Study Completion Date
April 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of this study is to determine the effect of tranexamic acid (TXA) on blood loss and transfusion requirements in patients with femur fractures requiring open surgical approaches.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss Following Open Femur Fracture Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic acid (TXA)
Arm Type
Experimental
Arm Description
Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline.
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid (TXA)
Intervention Description
Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline.
Primary Outcome Measure Information:
Title
Transfusion requirements as assessed by number of packed red blood cell units received
Time Frame
from the time of surgery to hospital discharge (about 3-5 days)
Secondary Outcome Measure Information:
Title
Surgical blood loss as assessed by change in red blood cell volume
Description
Blood loss will be determined using the following calculations:
[Patient's Blood Volume (PBV) = (k1 x Height^3 (m)) + (k2 x Weight (kg)) + k3] (- k1 = 0.3669, k2 = 0.03219, and k3 = 0.6041 for men) (- k1 = 0.3561, k2=0.03308, and k3 = 0.1833 for women)
Multiplying the PBV by the hematocrit (Hct) gives the red blood cell (RBC) volume. As such, a change in the RBC volume can be calculated from a change in the Hct level as follows. PACU is post-anesthesia care unit: [Operative RBC volume loss = PBV x (Day of surgery Hct - PACU Hct)]
If a patient requires an intraoperative transfusion, the calculation will be adjusted as follows:
Operative RBC volume loss = [ [PBV x (Day of surgery Hct - PACU Hct)] +)] + (No. of Units Transfused x 0.285) / (Day of surgery Hct - Post-op Hct) / 2) ]
Time Frame
baseline, while in PACU (which is about 4-6 hours after surgery)
Title
Surgical blood loss as assessed by an intraoperative cell salvage machine
Description
The intraoperative cell salvage machine allows for a precise estimation of surgical blood loss.
Time Frame
at the time of surgery
Title
Length of hospital stay
Time Frame
from the time of hospital admission to the time of hospital discharge (about 5 days)
Title
Number of participants with complications
Description
Complications include infection, venous thromboembolic event, and mortality.
Time Frame
6 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients admitted to Memorial Hermann Medical Center with acute femur fractures that require open surgical approaches for fracture reduction and implant application, including patients with subtrochanteric, high-energy intertrochanteric, periprosthetic, and intra-articular distal femur fractures.
Exclusion Criteria:
Preoperative use of any anticoagulant
History of deep venous thrombosis or pulmonary embolus
Allergy to TXA
Hepatic dysfunction (AST/ALT > 60)
Renal dysfunction (Cr > 1.5 or GFR < 30)
History of cerebrovascular accident in the past 12 months
Active coronary artery disease (event in the past 12 months)
Presence of drug-eluting stent
Color blindness
Presence of an additional acute injury that could contribute to blood transfusion requirements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen J Warner, MD, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery
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