Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboembolism
Conditions
Brief summary
The purpose of this study is to determine if weight-based heparin infusions at a rate of 10 units/kg/hour are sufficient to maintain a target anti-Xa of 0.1-0.35 IU/mL for VTE prophylaxis in patients undergoing microvascular surgery. Additionally, a pilot protocol has been developed to titrate these heparin infusions to ensure patients have sufficient VTE prophylaxis. All patients will be enrolled in the observational arm of the study and receive anti-Xa level monitoring. Patients with out-of-range anti-Xa levels will cross over to the interventional arm of the study and receive real time heparin infusion dose adjustments per the pilot protocol. The primary outcome measured will be the percentage of patients with anti-Xa levels in the target range of 0.1-0.35 IU/mL while on a heparin infusion at 10 units/kg/hour.
Interventions
Patients will be placed on heparin infusions per their surgeon's discretion.
Patients will have steady state anti-Xa levels drawn at least 6 hours after initiation of heparin infusion. Patients with out of range anti-Xa levels will receive real time heparin dose adjustment followed by repeat anti-Xa levels.
Sponsors
University of Utah
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing surgical procedures * Initiation of a heparin infusion at a rate of 500 units/hour intraoperatively or postoperatively
Exclusion criteria
* Age \<18 years old * Pregnant * Incarcerated * Mentally disabled
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Anti-Xa Levels Within Target Range (0.1-0.35 IU/mL) | Through study completion, an average of 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Number of Rate Adjustments | Through study completion, an average of 1 year |
Countries
United States
Outcome results
None listed