CHIPs-VTE Study in Hospitalized Patients With Lung Cancer

Venous thromboembolism (VTE) is a common complication of malignancies, in particular to lung cancer. Patients with lung cancer in surgical and medical departments are at high risk of VTE development. Prophylaxis is one major way to to prevent it. Currently, VTE prophylaxis is mainly based on VTE-risk assessment. However, all patients hospitalized for cancer are at intermediate or high risk of VTE but their bleeding risk vary. To improve effect of VTE prophylaxis and reduce bleeding events in patients with lung cancer, we will conduct an open-label parallel randomized clinical tria to assess the effect of bleeding risk based prophylaxis strategy among lung cancer patients. We hypothesize that VTE prophylaxis based on bleeding risk assessment with a short post-discharge treatment course is superior to VTE propohylaxis based on VTE risk assessment among hospitalized patients with lung cancer A sample of 3200 eligible patients will be randomized into experimental or control group with an allocation rate of 1:1. Stratified by medical/surgical units, block randomization with a varying block size of 4 or 6 will be adopted to randomize patients into experimental or control group. In experimental group, patients will undergo bleeding risk assessment and receive prophylaxis according to bleeding risk during hospitalization, and they will also receive an extended pharmacological prophylaxis of 5mg Rivaroxaban once daily for up to 15 consecutive days after discharge. In control group, patients will receive routine VTE prophylaxis, VTE risk assessment and prophylaxis if indicated during hospitalization according to current policies for hospitals in China but no further treatment prophylaxis after discharge. Patients in both groups will be followed up for 30 days. The primary outcome is symptomatic and asymptomatic objectively proven VTE (deep vein thrombosis (DVT) and/or pulmonary embolism (PE)) within 30 days after initiation of randomization. Ultrasound and CTPA will be performed to detect DVT and PE, respectively. Clinically relevant bleeding (non-major clinically relevant and major bleeding, HIT) and death are secondary outcomes.

Sex

All

Minimum age

40 Years

Patients with primary lung cancer admitted to medical units (for chemotherapy, complications, etc) or to surgical units for operations.

Inclusion criteria

1. Aged ≥40 years
2. Have an expected hospital stay ≥72 hours for medical and/or surgical treatment
3. Confirmed lung cancer at admission or proven lung cancer within prior 6 months
4. Evidence of active lung cancer within 6 prior months
5. Written informed consent

Exclusion criteria Patient-related criteria

1. Pregnancy or breastfeeding
2. Inability to be followed-up at until 3 months after randomization
3. have participated in similar trials or are undergoing other clinical trials
4. refuse or are unable to give informed consent VTE/bleeding-related criteria
5. Incidental VTE identified on spiral CT scans which are ordered primarily for staging the malignancy at or any time before enrollment
6. Neurosurgery, vascular procedures, orthopedic surgery intended during the admission
7. Severe renal failure not receiving dialysis (creatinine clearance \[CrCl\] \<30 mL/min), moderate to severe liver dysfunction, severe anemia
8. Uncontrolled hypertension (systolic blood pressure \[BP\] \>180 mmHg, diastolic BP \>110 mmHg)
9. severe platelet dysfunction or inherited bleeding disorder (such as haemophilia and von Willebrand's disease)
10. Acute stroke or recent stroke (within 4 weeks)
11. Recent major bleeding (within 3 months)
12. Requiring a full dose of anticoagulant treatment (e.g., recent VTE, atrial fibrillation)
13. Contraindication to heparin or rivaroxaban, e.g., heparin induced thrombocytopenia or history of documented episode of heparin or LMWH induced thrombocytopenia and/or thrombosis (HIT, HAT, or HITTS); recent central nervous system (CNS) bleed, hemorrhagic CNS metastases; active major bleeding with more than 2 units transfused in 24 hours.
14. Contraindication to mechanical prophylaxis, e.g., acute deep vein thrombosis, severe arterial insufficiency (pertains to graduated compression stockings only)
15. Concurrent use of anticoagulants known to increase the risk of bleeding (such as warfarin with INR\>2).

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