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Extended Out-of-hospital Low-molecular-weight Heparin Prophylaxis Against DVT and PE in Patients Undergoing Major Lung Resection

16 grudnia 2014 zaktualizowane przez: Yaron Shargall, McMaster University

Extended Out-of-hospital Low-molecular-weight Heparin Prophylaxis Against Deep Venous Thrombosis and Pulmonary Embolus in Patients Undergoing Major Lung Resection: A Pilot Study to Evaluate the Incidence of DVT and PE After Major Lung Resection

Postoperative venous thromboembolism (VTE) is a significant health-care problem, resulting in significant morbidity, mortality and resource utilization. The true incidence is unknown, and may range from 1% to 15%. At the current time, the clinical practice of VTE prophylaxis in thoracic surgery includes administration of unfractionated or low molecular weight heparin starting at the perioperative period and finishing at the time of patients' discharge. In orthopaedic surgery, prolonged thromboprophylaxis beyond 10 days and up to 35 days has become the standard of care. There is a clear need to systematically evaluate the incidence of VTE after resection of lung malignancies and to evaluate the role of extended VTE prophylaxis in preventing Deep Vein Thrombosis (DVT) and pulmonary embolus (PE) after those major lung resections. This study will involve patients undergoing lung resection for malignancy at St. Joseph's Healthcare Hamilton and the University Health Network's Toronto General Hospital. The study will include 150 consecutively recruited patients. Study interventions will include Computed Tomography with pulmonary embolus (PE) protocol and bilateral extended leg Doppler Ultrasound for the detection of Deep Vein Thrombosis 30 days post-surgery.

In summary, this study is aimed at evaluating, for the first time in a prospective manner, the actual incidence of DVT and PE in patients undergoing major lung resections for malignancies. The knowledge gained in this study will be used to inform a future investigation involving a Randomized Controlled Trial (RCT) to compare current post-operative thromboprophylaxis with an extended 30-day prophylaxis protocol with the hope of providing an evidence-based practice change in VTE prophylaxis care for this high risk population.

Przegląd badań

Szczegółowy opis

Postoperative venous thromboembolism (VTE) is a significant health-care problem, resulting in significant morbidity, mortality and resource utilization. The true incidence is unknown, and may range from 1% to 15%. The latest American College of Chest Physicians (ACCP) guidelines on VTE prevention clearly outlines the perioperative thromboprophylaxis regiments for specific surgical populations. Specifically for patients undergoing orthopaedic procedures, such as total hip replacement, there is strong Grade 1A evidence for the use of extended thromboprophylaxis. For other surgical subgroups such as vascular and thoracic surgery, the evidence is less clear.

Therefore at the current time, the clinical practice of VTE prophylaxis in thoracic surgery includes administration of unfractionated or low molecular weight heparin starting at the perioperative period and finishing at the time of patients' discharge. Prolonged thromboprophylaxis in orthopaedic surgery beyond 10 days and up to 35 days has become the standard of care and has Grade 1A recommendations from ACCP. This approach has never been tested or validated in thoracic surgery, where major lung resection exposes the patient to an increased VTE risk not only due to the surgical stress and existence of malignancy, but also due to direct in-situ vascular injury secondary to resection of pulmonary arterial branches during the lung resection. Hence, there is a clear need to systematically evaluate the incidence of VTE after resection of lung malignancies and to evaluate the role of extended VTE prophylaxis in preventing DVT and pulmonary embolus (PE) after those major lung resections.

The study will involve patients undergoing sub-lobar resection, lobectomy, bilobectomy or pneumonectomy for lung cancer or metastatic lung disease at St. Joseph's Healthcare Hamilton, a regional tertiary thoracic surgery program with more than 350 major lung resections performed within the institution annually, as well as the University Health Network's Toronto General Hospital. The study will evaluate the incidence of post-operative venous thromboembolism (VTE) and will include 150 consecutively recruited patients. Study interventions will include Computed Tomography with pulmonary embolus (PE) protocol and bilateral extended leg Doppler Ultrasound for the detection of Deep Vein Thrombosis 30 days post-surgery.

In summary, this study is aimed at evaluating, for the first time in a prospective manner, the actual incidence of DVT and PE in patients undergoing major lung resections for malignancies. The knowledge gained in this study will be used to inform a future investigation involving an RCT to compare current post-operative thromboprophylaxis with an extended 30-day prophylaxis protocol with the hope of providing an evidence-based practice change in VTE prophylaxis care for this high risk population.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

150

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Ontario
      • Hamilton, Ontario, Kanada, L8N 4A6
        • St. Joseph's Healthcare Hamilton
      • Toronto, Ontario, Kanada, M5G 2C4
        • Toronto General Hospital (UHN)

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

All adults of at least 18 years of age who are to undergo sub-lobar resection, lobectomy, bilobectomy or pneumonectomy for lung cancer or metastatic lung disease will be offered the opportunity to participate in the study. The inclusion criteria are intentionally broad to increase the generalizability of the study. Eligibility criteria will be considered for enrollment in the study and are listed in the methodology section. The study population for both phases one and two of the study will have the same inclusion and exclusion criteria but will not include the same participants.

Opis

Patient Inclusion Criteria

  • At least 18 years of age
  • Either gender
  • Diagnosed with resectable lung cancer or metastatic lung disease eligible to complete metastasectomy
  • Undergoing one of the following surgeries: Segmentectomy, wedge resection, lobectomy, bilobectomy or pneumonectomy
  • Competent to understand and sign consent documents

Patient Exclusion Criteria

  • Known allergic or anaphylactic reaction to contrast dye, heparin or low molecular weight heparin (LMWH)
  • Under current anticoagulation for venous thromboembolism or other medical conditions
  • Known renal impairment, defined as creatinine clearance value of less than 55ml/min/m2 as calculated by the Cockroft-Gault method
  • History of, or ongoing liver disease, manifested as ascites or previous peritoneal tapping for ascites
  • Pregnant or planning to become pregnant
  • Diagnosed or treated for VTE in the past 3 months prior to surgery
  • Present or previous increase risk of haemorrhage
  • History of previous HIT (heparin induced thrombocytopenia)
  • Platelet count must be below 75,000
  • Previously inserted Inferior Vena Cava Filter (IVC) filter.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Ramy czasowe
To determine the incidence of PE/DVT after lung resection for malignancies
Ramy czasowe: 30 days post hospital discharge
30 days post hospital discharge

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Incidence of post-operative PE and DVT comparing thoracotomy vs. VATS
Ramy czasowe: 30 days post hospital discharge
30 days post hospital discharge
Complications and mortality of DVT and PE post lung resection
Ramy czasowe: 30 days post hospital discharge
30 days post hospital discharge
Risk factors for the development of VTE post lung resection
Ramy czasowe: 30 days post hospital discharge
30 days post hospital discharge
Correlation between DVT and PE in patients developing PE
Ramy czasowe: 30 days post hospital discharge
In this specific population, many PE events might not be initiated by VTE, but rather by the result of in-situ arterial injury such as division, tying and/or clamping of the pulmonary artery branches during the lung resection. As a result, we postulate that we might identify patients with PE without a preceding DVT.
30 days post hospital discharge

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Yaron Shargall, MD BSc, St. Joseph's Healthcare Hamilton

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 stycznia 2014

Zakończenie podstawowe (Rzeczywisty)

1 grudnia 2014

Ukończenie studiów (Rzeczywisty)

1 grudnia 2014

Daty rejestracji na studia

Pierwszy przesłany

3 października 2014

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 października 2014

Pierwszy wysłany (Oszacować)

8 października 2014

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

18 grudnia 2014

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

16 grudnia 2014

Ostatnia weryfikacja

1 grudnia 2014

Więcej informacji

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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