The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery

Phase 4

Withdrawn

• Conditions: Blood Loss Following Open Femur Fracture Surgery
• Interventions: Drug: Tranexamic acid (TXA); Drug: Normal saline

• Registration Number: NCT03679481
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-24
• Study First Submitted QC: 2018-09-19
• Study First Posted: 2018-09-20
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-14
• Last Update Posted: 2019-10-17
• Study Start: 2020-04-01
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid (TXA)	Tranexamic acid (TXA)	Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline.
Normal saline	Normal saline	Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline.

Primary Outcome Measures

Name	Time	Method
Transfusion requirements as assessed by number of packed red blood cell units received	from the time of surgery to hospital discharge (about 3-5 days)

Secondary Outcome Measures

Name	Time	Method
Surgical blood loss as assessed by an intraoperative cell salvage machine	at the time of surgery	The intraoperative cell salvage machine allows for a precise estimation of surgical blood loss.
Surgical blood loss as assessed by change in red blood cell volume	baseline, while in PACU (which is about 4-6 hours after surgery)	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) \]
Length of hospital stay	from the time of hospital admission to the time of hospital discharge (about 5 days)
Number of participants with complications	6 weeks after surgery	Complications include infection, venous thromboembolic event, and mortality.