Early Phase 1
N=20
Evaluation of Anti-Xa Levels in Surgery Patients Receiving Fixed Dose Heparin
Deep-Venous Thrombosis · Pulmonary Embolism · Venous Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT02970032 ↗Enrolled (actual)
20
Serious AEs
5.0%
Results posted
Jun 2019
Primary outcome: Primary: Number of Participants With Anti-Xa Levels Within Target Range (0.1-0.35 IU/mL) — 0; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Real time heparin dose adjustment (Drug); Standard heparin dose (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Anti-Xa Levels Within Target Range (0.1-0.35 IU/mL) |
0; 12 | — |
| SECONDARY Number of Rate Adjustments |
4.5 | — |
Summary
The purpose of this study is to determine if fixed dose heparin infusions at a rate of 500 units/hour are sufficient to maintain a target anti-Xa of 0.1-0.35 IU/mL for venous thromboembolism (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 500 units/hour.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02970032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.