CHIPs-VTE Study in Hospitalized Patients With Lung Cancer
- Conditions
- Pulmonary EmbolismDeep Venous ThrombosisVenous Thromboembolic Disease
- Interventions
- Other: Bleeding-risk based prophylaxis strategy during hospitalization and extended pharmacological treatment after dischargeOther: Routine VTE prophylaxis in hospital
- Registration Number
- NCT04158973
- Lead Sponsor
- China-Japan Friendship Hospital
- Brief Summary
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.
- Detailed Description
Randomization and sequence generation A computerized random-number generator will be used to generate the allocation sequence. In this multicenter trial involving 10 hospitals, randomization procedures will be organized centrally.
Stratified block randomization with a varying block size of 4 or 6 will be used to allocate patients into experimental or control group. Patients with lung cancer will be stratified into those under planned medical or surgical treatments.
In each stratum, patients will be blocked according to their admission sequence. Four or six patients consecutively admitted will be one block depending on the block size. In each block, patients will be randomly allocated into experimental or control group according to sequence generated in advance by software.
Allocation concealment/Blinded randomization Patient assignments will be enclosed in a sequentially numbered, opaque, sealed envelopes (SNOSE). Clinicians in charge of patient enrollment will not know the allocation sequence until eligible patients who meet inclusion and exclusion criteria are enrolled.
An independent statistician will generate the random allocation sequence. Physicians will enroll participants and assign interventions in experimental or control group.
Blinding/Open label This is an open-label trial that patients, clinicians and researchers will know allocation assignments after enrollment. But imaging experts providing the duplex ultrasound and CTPA results will be blinded in order to objectively assess the 30-day CTPA-proven VTE incidence and other outcomes in both groups. An independent data monitoring board will evaluate the trial data and safety.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 3200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VTE prophylaxis based on bleeding risk assessment Bleeding-risk based prophylaxis strategy during hospitalization and extended pharmacological treatment after discharge Patients will undergo a bleeding risk assessment to determine their entering VTE prophylaxis. Low bleeding risk patients will have once daily sc LMWH prophylaxis. Intermediate bleeding risk patients will have q 12 h sc low dose unfractionated heparin prophylaxis. High bleeding risk patients will have mechanical prophylaxis. Assigned prophylaxis can be interrupted as clinical judgement requires, e.g., for peri-procedural reasons. When patients are discharged, if they have low risk of bleeding at the time of discharge, whatever their bleeding risk assessment at the time of randomization, will begin 5 mg rivaroxaban prophylaxis (two 2.5 mg tablets) once daily with food, starting on the day of discharge, for 15 days. Routine VTE prophylaxis in local clinical practice Routine VTE prophylaxis in hospital VTE risk assessment and prophylaxis if indicated during hospitalization according to current policies for hospitals in China but no further treatment prophylaxis after discharge.
- Primary Outcome Measures
Name Time Method Incidence of symptomatic and asymptomatic objectively proven VTE 30 days after randomization PE incidence detected by CTPA and/or DVT by ultrasound
- Secondary Outcome Measures
Name Time Method Clinically relevant bleeding 30 days after randomization Bleeding that occur in the study
All-cause mortality 30 days after randomization All-cause deaths that occur during study
Adverse events 30 days after randomization Safety events related to drug use