Thoracic Surgery Extended Low-Molecular Weight Heparin VTE Prophylaxis--Pilot Trial
Information source: McMaster University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Venous Thromboembolism; Lung Neoplasms; Pulmonary Embolism
Intervention: LMWH: Dalteparin (Drug); Placebo (Other)
Phase: Phase 1/Phase 2
Status: Not yet recruiting
Sponsored by: McMaster University Official(s) and/or principal investigator(s): Yaron Shargall, MD BSc, Principal Investigator, Affiliation: McMaster University
Overall contact: Laura Schneider, BSc, Phone: 905-522-1155, Ext: 35877, Email: lschnei@mcmaster.ca
Summary
After any surgery, there is a risk of venous thromboembolism (VTE), including Deep Vein
Thrombosis (DVT) in the major veins of the legs and Pulmonary Embolus (PE) in the lungs.
These clots are usually prevented by the administration of low-molecular-weight heparin, a
blood thinner that prevents clotting. In most surgical specialties like thoracic or vascular
surgery, this treatment is used until patients are discharged from the hospital. However, in
orthopaedic surgery, there is strong evidence that longer term preventative treatment up to
35 days after hospital discharge helps to reduce VTE occurrences. In thoracic surgery, there
is an even greater risk of developing PE because of the surgical stress, the common presence
of cancer and direct damage to blood vessels in the lung during surgery. Despite the
potential utility, the use of extended VTE prevention has never been evaluated in the
thoracic surgery population. If extended treatment prevents clots, more patients will avoid
complications related to VTE. There is currently very limited information available on the
incidence of venous thromboembolism (VTE) in patients undergoing lung cancer resection and
the utility of extended thromboprophylaxis (ET) in this patient population. Furthermore, in
contrast to patients undergoing orthopaedic surgery where ET has become standard of care,
duration of thromboprophylaxis is not well defined in this patient population. Therefore,
there is a clear need to systematically evaluate the effects of extended VTE prophylaxis on
the incidence of VTE in the post-op population.
Clinical Details
Official title: Extended Low-Molecular Weight Heparin VTE Prophylaxis in the Thoracic Surgery Population--a Randomized Controlled Pilot Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Composite primary outcome: To determine the feasibility of a full scale trial by determining the recruitment rates and loss to follow up rates
Secondary outcome: Clinical outcome:Comparison of Incidence of DVT and PE at 30 days after surgery between control and interventional arms (Outcome will be measured by a Chest Computed Tomography (CT) scan with PE contrast protocol and a full leg doppler ultrasound)Occurrence of major and minor bleeding at 30 days post-surgery, +/- 5 days Comparison of mortality within 90 days of surgery between control and interventional arms Number of cases of heparin administration related HIT (Heparin Induced Thrombocytopenia) within 90 days of surgery Number of participants with study-related adverse events within 90 days of surgery Comparison of non-DVT-associated PE events (those occurring without an antecedent DVT) between control and interventional arms
Detailed description:
There is currently very limited information available on the incidence of venous
thromboembolism (VTE) in patients undergoing lung cancer resection and the utility of
extended thromboprophylaxis (ET) in this patient population. Furthermore, in contrast to
patients undergoing orthopaedic surgery where ET has become standard of care, duration of
thromboprophylaxis is not well defined in this patient population. Therefore, there is a
clear need to systematically evaluate the effects of extended VTE prophylaxis on the
incidence of VTE in the post-op population.
As a pilot study, the primary outcome will involve feasibility measures. The investigators
aim to measure the proportion of recruitment within each centre, compliance, loss to
follow-up, and tolerability of the intervention, defined as the number and severity of
per-defined adverse events. The primary outcome of interest for the future full-scale trial
is the 30-day incidence rate of VTE following extended 30-day prophylaxis (defined as
pulmonary emboli or deep venous thromboembolism of the lower limb as detected by CT
(Computed Tomography) pulmonary angiography and full leg Doppler ultrasound, respectively)
following lung resection for malignancies.
The proposed pilot project is a multicenter blinded placebo-controlled randomized controlled
pilot clinical trial assessing the feasibility and effectiveness of extended-duration VTE
prophylaxis (30 days post-operatively) vs. short-term prophylaxis restricted to in-hospital
stay with outpatient injected placebo, in patients undergoing lung resection for lung cancer
or metastatic disease. All patients will receive both a peri-operative dose followed by
postoperative VTE prophylaxis for the duration of their hospital stay. Those who were
randomized to prolonged prophylaxis will continue the same dosage regime for an overall of
30 days, whereas the control group will receive placebo injections for the same duration of
time.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients must be at least 18 years of age
- Patient may be of either gender
- Patients must be diagnosed with resectable lung cancer or metastatic lung disease
eligible to complete metastasectomy
- Patients must be undergoing one of the following surgeries: Segmentectomy, wedge
resection, lobectomy, bilobectomy or pneumonectomy
- Patients must be competent to understand consent documents
Exclusion Criteria:
- All patients with known allergic or anaphylactic reaction to contrast dye, heparin or
low molecular weight heparin (LMWH)
- Patients must not be under current anticoagulation for venous thromboembolism or
other medical conditions
- Patients must not have known renal impairment (defined as estimated glomerular
filtration rate of less than 30ml/min/m2 as calculated by the Cockcroft-Gault method)
either pre-operatively or as identified based on blood work obtained prior to the
scheduled 30-day post-operative scan
- Patients must not have known hepatic failure, with international normalized ratio
(INR) of >1. 5
- Patients with history of, or ongoing liver disease, manifested as ascites or previous
peritoneal tapping for ascites
- Patients must not be pregnant or planning to become pregnant
- Patients must not have been diagnosed or treated for VTE in the past 3 months prior
to surgery
- Patients must not have a known, objectively confirmed bleeding disorder
- Patients must not have a present or previous increase risk of haemorrhage
- Patients must not have a history of previous heparin induced thrombocytopenia
- Baseline platelet count <75,000 but transient, recovered thrombocytopenia associated
with chemotherapy will not be a basis for exclusion
- Patients must not have previously inserted inferior vena cava filter.
Locations and Contacts
Laura Schneider, BSc, Phone: 905-522-1155, Ext: 35877, Email: lschnei@mcmaster.ca
St. Joseph's Healthcare Hamilton, Hamilton, Ontario L8N 4A6, Canada; Not yet recruiting Yaron Shargall, MD, Principal Investigator Christian J Finley, MD MPH, Sub-Investigator Colin Schieman, MD, Sub-Investigator Wael C Hanna, MDCM, MBA, Sub-Investigator Forough Farrokhyar, PhD, Sub-Investigator Mark Crowther, MD MSc, Sub-Investigator Lori Ann Linkins, MD MSc, Sub-Investigator James Douketis, MD, Sub-Investigator
Toronto General Hospital (UHN), Toronto, Ontario M5G 2C4, Canada; Not yet recruiting Jennifer Lister, BSc, Phone: 4163404857, Email: jennifer.lister@uhn.ca Thomas K Waddell, MD PhD FRCSC, Sub-Investigator Marc De Perrot, MD MSc, Principal Investigator
Additional Information
Starting date: February 2015
Last updated: January 7, 2015
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