Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery
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|ClinicalTrials.gov Identifier: NCT02334007|
Recruitment Status : Recruiting
First Posted : January 8, 2015
Last Update Posted : April 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Venous Thromboembolism Lung Neoplasms Pulmonary Embolism||Drug: LMWH: Dalteparin Other: Placebo||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Extended Low-Molecular Weight Heparin VTE Prophylaxis in the Thoracic Surgery Population, a Prospective, Randomized Controlled Study|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||July 2018|
Experimental: LMWH: Dalteparin
Consenting patients undergoing lung resection will receive standard postoperative thromboprophylaxis in hospital until the time of discharge. Subsequently, patients will be administered LMWH for duration of 30 days as outpatients.
Drug: LMWH: Dalteparin
Dalteparin is a low-molecular weight heparin. The dosage used will be 5000 units once daily (administered as a subcutaneous injection). This is an established prophylactic dose used to prevent the incidence of VTE after surgery.
Other Name: Fragmin
Placebo Comparator: Placebo
After undergoing lung resection these patients will research standard post-op TE prophylaxis and upon discharge will be administered a placebo injection of subcutaneous saline for 30 days duration.
Upon hospital discharge, half of the patients will be assigned to receive saline placebo injections for up to 35 days after surgery. These injections will have no effect.
- Composite primary outcome: To determine the feasibility of a full scale trial by determining the recruitment rates and loss to follow up rates [ Time Frame: 1-1.5 years ]Measuring accrual rates, patient compliance, adherence to protocol, any-cause loss to follow up, tolerability of the intervention (safety), adverse events, and coordination of participating centre infrastructure
- 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) [ Time Frame: 30 days, +/- 5 days ]As a pilot study, there is an insufficient number of patients to definitively calculate incidence and compare treatment arms. However, this is a key outcome and the study will seek to determine this outcome. Outcome will be measured by a Chest Computed Tomography (CT) scan with PE contrast protocol and a full leg doppler ultrasound at approximately 30 days after surgery to seek the occurrence of clots
- Occurrence of major and minor bleeding at 30 days post-surgery, +/- 5 days [ Time Frame: 30 days after surgery ]Bleeding is a potential adverse event of Fragmin use. Major bleeding is defined as: Fatal bleeding OR Critical bleeding in a symptomatic area (intracranial, intraspinal, retroperitoneal, pericardial, or intramuscular with compartment syndrome) OR Bleeding causing a fall in hemoglobin level of 2g/dL or more as measured by a blood test at 30 days follow up, OR Bleeding requiring a blood transfusion of at least 2 units of packed red blood cells (excluding transfusions administered intra-operatively or 6-hrs post-operatively since these could not be impacted by post-surgical prophylaxis). Minor bleeding is defined as any bleeding episode not classified as major.
- Comparison of mortality within 90 days of surgery between control and interventional arms [ Time Frame: 90 days ]Both procedure-specific and all-cause mortality rates will be calculated
- Number of cases of heparin administration related HIT (Heparin Induced Thrombocytopenia) within 90 days of surgery [ Time Frame: 90 days ]
- Number of participants with study-related adverse events within 90 days of surgery [ Time Frame: 90 days ]
- Comparison of non-DVT-associated PE events (those occurring without an antecedent DVT) between control and interventional arms [ Time Frame: 90 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334007
|Contact: Yaron Shargall, MD, FRCSC, FCCP||905-522-1155 ext 33229|
|St. Joseph's Healthcare Hamilton||Recruiting|
|Hamilton, Ontario, Canada, L8N 4A6|
|Credit Valley Hospital||Recruiting|
|Mississauga, Ontario, Canada, L5M 2N1|
|Toronto General Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Yaron Shargall, MD, FRCSC, FCCP||McMaster University|