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Venous Thromboembolic DiseaseNCT04158973

CHIPs-VTE Study in Hospitalized Patients With Lung Cancer

A study testing Bleeding-risk based prophylaxis strategy during hospitalization and extended pharmacological treatment after discharge and Routine VTE prophylaxis in hospital in people with Venous Thromboembolic Disease and Pulmonary Embolism, run by China-Japan Friendship Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Bleeding-risk based prophylaxis strategy during hospitalization and extended pharmacological treatment after discharge and Routine VTE prophylaxis in hospital
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,200 participants
Where
No sites listed yet
Study dates
1 Dec 2021to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Pregnancy or breastfeeding
  • Inability to be followed-up at until 3 months after randomization
  • have participated in similar trials or are undergoing other clinical trials
  • refuse or are unable to give informed consent VTE/bleeding-related criteria
  • Incidental VTE identified on spiral CT scans which are ordered primarily for staging the malignancy at or any time before enrollment
  • Neurosurgery, vascular procedures, orthopedic surgery intended during the admission
Show all 15Show fewer
  • Severe renal failure not receiving dialysis (creatinine clearance [CrCl] <30 mL/min), moderate to severe liver dysfunction, severe anemia
  • Uncontrolled hypertension (systolic blood pressure [BP] >180 mmHg, diastolic BP >110 mmHg)
  • severe platelet dysfunction or inherited bleeding disorder (such as haemophilia and von Willebrand's disease)
  • Acute stroke or recent stroke (within 4 weeks)
  • Recent major bleeding (within 3 months)
  • Requiring a full dose of anticoagulant treatment (e.g., recent VTE, atrial fibrillation)
  • 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.
  • Contraindication to mechanical prophylaxis, e.g., acute deep vein thrombosis, severe arterial insufficiency (pertains to graduated compression stockings only)
  • Concurrent use of anticoagulants known to increase the risk of bleeding (such as warfarin with INR>2).

Trial locations and contacts

No sites are listed yet.

Zhenguo Zhai, Doctor contact

86-10-84206265

zhaizhenguo2011@126.com

About this study

Official title: Bleeding Risk Guided VTE Prophylaxis Strategy for Hospitalized Patients With Lung Cancer: Rationale and Design for a Multicenter, Adjudicator-blinded, Parallel, Randomized Clinical Trial in China

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.

Read the 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.

Being tested
Bleeding-risk based prophylaxis strategy during hospitalization and extended pharmacological treatment after discharge, Routine VTE prophylaxis in hospital
Medical subject headings
Pulmonary Embolism, Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bleeding-risk based prophylaxis strategy during hospitalization and extended pharmacological treatment after dischargeOther

    At admission, patents undergo bleeding risk assessment and receive prophylaxis according to bleeding risk. After discharge, they will undergo an extended treatment of 5mg Rivaroxaban once daily for 15 consecutive days,

  • Routine VTE prophylaxis in hospitalOther

    Patients randomized to the standard treatment (Control) group will receive routine VTE prophylaxis according to current guidelines and clinical practices, VTE risk assessment and prophylaxis if indicated during hospitalization according to current policies for hospitals in China but no further treatment prophylaxis after discharge

Study groups in NCT04158973
Study groupRoleWhat they receive
VTE prophylaxis based on bleeding risk assessmentExperimentalPatients 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.
Receives: Other: Bleeding-risk based prophylaxis strategy during hospitalization and extended pharmacological treatment after discharge
Routine VTE prophylaxis in local clinical practiceActive comparatorVTE risk assessment and prophylaxis if indicated during hospitalization according to current policies for hospitals in China but no further treatment prophylaxis after discharge.
Receives: Other: Routine VTE prophylaxis in hospital

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of symptomatic and asymptomatic objectively proven VTE

    PE incidence detected by CTPA and/or DVT by ultrasound

    Measured: 30 days after randomization

Secondary outcomes (3)
  1. All-cause mortality

    All-cause deaths that occur during study

    Measured: 30 days after randomization

  2. Clinically relevant bleeding

    Bleeding that occur in the study

    Measured: 30 days after randomization

  3. Adverse events

    Safety events related to drug use

    Measured: 30 days after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2019
  2. Study start1 Dec 2021 (estimated)
  3. Primary completion30 Apr 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04158973
Sponsor's protocol ID
CHIPs-VTE in lung cancer
Status last verified
Aug 2021
First submitted
4 Sep 2019
Last updated
3 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vitale C, D'Amato M, Calabro P, Stanziola AA, Mormile M, Molino A. Venous thromboembolism and lung cancer: a review. Multidiscip Respir Med. 2015 Sep 15;10(1):28. doi: 10.1186/s40248-015-0021-4. eCollection 2015.

    PubMed 26380084
  • Connolly GC, Dalal M, Lin J, Khorana AA. Incidence and predictors of venous thromboembolism (VTE) among ambulatory patients with lung cancer. Lung Cancer. 2012 Dec;78(3):253-8. doi: 10.1016/j.lungcan.2012.09.007. Epub 2012 Sep 29.

    PubMed 23026639
  • Zhang Y, Yang Y, Chen W, Guo L, Liang L, Zhai Z, Wang C; China Venous Thromboembolism (VTE) Study Group. Prevalence and associations of VTE in patients with newly diagnosed lung cancer. Chest. 2014 Sep;146(3):650-658. doi: 10.1378/chest.13-2379.

    PubMed 24676401
  • Song C, Shargall Y, Li H, Tian B, Chen S, Miao J, Fu Y, You B, Hu B. Prevalence of venous thromboembolism after lung surgery in China: a single-centre, prospective cohort study involving patients undergoing lung resections without perioperative venous thromboembolism prophylaxisdagger. Eur J Cardiothorac Surg. 2019 Mar 1;55(3):455-460. doi: 10.1093/ejcts/ezy323.

    PubMed 30289479
  • Lyman GH, Kuderer NM; American Society of Clinical Oncology. Prevention and treatment of venous thromboembolism among patients with cancer: the American Society of Clinical Oncology Guidelines. Thromb Res. 2010 Apr;125 Suppl 2:S120-7. doi: 10.1016/S0049-3848(10)70029-3. No abstract available.

    PubMed 20433991
  • Zhai Z, Kan Q, Li W, Qin X, Qu J, Shi Y, Xu R, Xu Y, Zhang Z, Wang C; DissolVE-2 investigators. VTE Risk Profiles and Prophylaxis in Medical and Surgical Inpatients: The Identification of Chinese Hospitalized Patients' Risk Profile for Venous Thromboembolism (DissolVE-2)-A Cross-sectional Study. Chest. 2019 Jan;155(1):114-122. doi: 10.1016/j.chest.2018.09.020. Epub 2018 Oct 6.

    PubMed 30300652

Questions about this trial

What is this clinical trial studying?

A study testing Bleeding-risk based prophylaxis strategy during hospitalization and extended pharmacological treatment after discharge and Routine VTE prophylaxis in hospital in people with Venous Thromboembolic Disease and Pulmonary Embolism, run by China-Japan Friendship Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhenguo Zhai, Doctor (86-10-84206265, zhaizhenguo2011@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of symptomatic and asymptomatic objectively proven VTE (time frame: 30 days after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04158973, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.

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