- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02687204
Twice Daily Enoxaparin Prophylaxis in Reconstructive Surgery Patients
Optimization of Enoxaparin Prophylaxis Using Real-time Anti-Factor Xa Levels in Major Reconstructive Surgery Patients
Blood clots that form in the extremities (deep venous thrombosis) and lungs (pulmonary embolus) are feared complications of reconstructive surgery. One in ten patients with symptomatic pulmonary embolus will be dead in 60 minutes. Patients with deep venous thrombosis can develop the post-thrombotic syndrome, known to be a major driver of poor quality of life. These phenomena, broadly known as venous thromboembolism (VTE), have substantial downstream ramifications, and the US Surgeon General and the American Society of Plastic Surgeons (ASPS), among others, have underscored the importance of VTE prevention in surgical patients. Reconstructive surgery, most commonly performed to fix traumatic injuries or defects after cancer excision, often involves borrowing tissue from adjacent or distant areas on the body; reconstructive surgery patients can routinely have surgical injury involving 20% or more of their total body surface area. Injury and resultant inflammation are known to increase metabolism of certain drugs, including those used to prevent VTE after surgery.
Enoxaparin is a blood-thinning medication that decreases likelihood of blood clot formation. Previous research has shown that reconstructive surgery patients who are given enoxaparin after surgery are less likely to develop VTE. However, despite receiving of a standard dose of enoxaparin, many patients still develop this life-threatening complication. The investigators believe that patients metabolize enoxaparin differently based on the degree of surgical injury created during reconstruction, and seek to critically examine enoxaparin metabolism in reconstructive surgery patients. The proposed research will evaluate how enoxaparin affects the blood based on standard, ASPS-recommended dosing after reconstructive surgeries; the investigators will also examine whether the extent of surgical injury alters metabolism as well. Enoxaparin effectiveness will be tracked using anti-Factor Xa (aFXa) levels. If subtherapeutic aFXa levels are observed, the study will also design, implement and test a clinical enoxaparin dose-adjustment protocol to achieve appropriate post-operative aFXa levels. Further research based on these data will examine reduction in VTE risk when aFXa-driven enoxaparin dosing is used.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Utah
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Salt Lake City, Utah, Forente stater, 84132
- University of Utah Hospitals
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion criteria:
- Adult patients having plastic and reconstructive surgery who are placed on twice daily enoxaparin prophylaxis after surgery.
Exclusion criteria:
- Contraindication to use of enoxaparin.
- Intracranial bleeding/stroke, hematoma or bleeding disorder.
- Known heparin-induced thrombocytopenia
- Creatinine clearance ≤30mL/min
- Serum creatinine >1.6mg/dL
- Epidural anesthesia.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Enoxaparin prophylaxis
All enrolled patients will receive twice daily enoxaparin prophylaxis.
Patients with identified out of range peak anti-Xa levels will receive real time dose adjustment and will be considered as the experimental arm.
|
Patients will have peak and trough steady state anti-Xa levels drawn.
For patients with out of range peak levels, real time enoxaparin dose adjustment using a clinical protocol will be performed.
Repeat steady state levels will be checked.
Andre navn:
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Eksperimentell: Real time dose adjustment
Patients with identified out of range peak anti-Xa levels will receive real time enoxaparin dose adjustment
|
Patients will have peak and trough steady state anti-Xa levels drawn.
For patients with out of range peak levels, real time enoxaparin dose adjustment using a clinical protocol will be performed.
Repeat steady state levels will be checked.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of patients with a 90-day VTE (either a 90-day DVT or 90-day PE)
Tidsramme: 90 days
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Outcome measure number one will be deep venous thrombosis or pulmonary embolus confirmed with imaging within 90 days of the initial surgery.
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90 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of patients with a 90-day re-operative hematoma
Tidsramme: 90 days
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Outcome number two will be bleeding (hematoma) requiring return to the operating room within 90 days of the initial operation.
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90 days
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Christopher Pannucci, MD MS, University of Utah
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Pannucci CJ, Fleming KI, Agarwal J, Rockwell WB, Prazak AM, Momeni A. The Impact of Once- versus Twice-Daily Enoxaparin Prophylaxis on Risk for Venous Thromboembolism and Clinically Relevant Bleeding. Plast Reconstr Surg. 2018 Jul;142(1):239-249. doi: 10.1097/PRS.0000000000004517.
- Pannucci CJ, Fleming KI, Momeni A, Prazak AM, Agarwal J, Rockwell WB. Twice-Daily Enoxaparin among Plastic Surgery Inpatients: An Examination of Pharmacodynamics, 90-Day Venous Thromboembolism, and 90-Day Bleeding. Plast Reconstr Surg. 2018 Jun;141(6):1580-1590. doi: 10.1097/PRS.0000000000004379.
- Pannucci CJ, Fleming KI. Comparison of face-to-face interaction and the electronic medical record for venous thromboembolism risk stratification using the 2005 Caprini score. J Vasc Surg Venous Lymphat Disord. 2018 May;6(3):304-311. doi: 10.1016/j.jvsv.2017.10.016. Epub 2018 Feb 13.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Sykdommer i luftveiene
- Lungesykdommer
- Embolisme og trombose
- Embolisme
- Trombose
- Venøs trombose
- Tromboemboli
- Venøs tromboembolisme
- Lungeemboli
- Molekylære mekanismer for farmakologisk virkning
- Fibrinolytiske midler
- Fibrinmodulerende midler
- Antikoagulanter
- Enoksaparin
- Enoksaparinnatrium
Andre studie-ID-numre
- 86052
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- Statistisk analyseplan (SAP)
Legemiddel- og utstyrsinformasjon, studiedokumenter
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