Blood Loss Following Open Femur Fracture Surgery Clinical Trial
Official title:
The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery
| Verified date | October 2019 |
| Source | The University of Texas Health Science Center, Houston |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | April 1, 2021 |
| Est. primary completion date | April 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| The University of Texas Health Science Center, Houston |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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) ] |
baseline, while in PACU (which is about 4-6 hours after surgery) | |
| Secondary | 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. | at the time of surgery | |
| Secondary | Length of hospital stay | from the time of hospital admission to the time of hospital discharge (about 5 days) | ||
| Secondary | Number of participants with complications | Complications include infection, venous thromboembolic event, and mortality. | 6 weeks after surgery |