Colorectal CancerNCT06259149
A Study of Initiation Timing of VTE Prevention After Colorectal Cancer Surgery
An observational study of Colorectal Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
This project intends to conduct a single-center, prospective, observational cohort study to explore the impact of the timing of drug prophylaxis on the risk of postoperative bleeding and the preventive effect of VTE in the prevention and management of postoperative venous thromboembolism (VTE) after colorectal cancer… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Nardraparin calcium injection
- Type of treatment
- Injection or infusion
- How many people
- 914 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 1 Jun 2025
- Phase
- Observational
- 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 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient was diagnosed with colorectal cancer and underwent radical surgery (laparoscopic or open surgery) with an estimated operation time of >45 minutes. Patients with expected survival >6 months after surgery
Who may be able to join
- ① Age > 18 years old;
- ② The patient was diagnosed with colorectal cancer, and the cTMN stage was cT1-2, N0 or cT3, N0 or any cT, N1-2; (3) The patient was diagnosed with colorectal cancer and was able to receive radical surgery (laparoscopic or open surgery). The expected operation time was >45 minutes, and the expected postoperative survival time was >6 months.
- ④ The patient or guardian agrees to the study plan and signs the informed consent.
Who cannot join
- ① Renal insufficiency (CrCl<30 mL/min) or hepatic insufficiency (ALT> 3 times the upper limit of normal);
- The patient was diagnosed with colorectal cancer with a cTMN stage of cT4 and/or local unresectable lesions. Unresectable local recurrent lesions included: (1) extensive lateral pelvic wall invasion, (2) external iliac vascular involvement, (3) tumor invasion into the great sciatic notch, sciatic nerve invasion, and (4) invasion of the second sacrum level and above.
- Known allergy to low molecular weight heparin (LWMH), narcotic drugs or radiocontrast agents; The presence of systemic hemorrhagic disease or bleeding tendency, such as active peptic ulcer, uncontrolled hypertension, cerebral thrombosis, cerebral hemorrhage or neurosurgical history within 6 months;
- known brain metastases, endocarditis, or history of heparin-induced thrombocytopenia;
- VTE occurred within 3 months before surgery;
- Use heparin or oral anticoagulant therapy within 5 days before surgery; Women who are pregnant or breastfeeding;
- Any situation in which the investigator determines that the subject is not suitable for anticoagulant therapy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastrointestinal Surgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Meng Hu, PhD, +8615000090636, humeng@renji.com
About this study
Official title: A Study of Initiation Timing of VTE Prevention After Colorectal Cancer Surgery: a Single-center, Prospective, Observational Cohort Study
This project intends to conduct a single-center, prospective, observational cohort study to explore the impact of the timing of drug prophylaxis on the risk of postoperative bleeding and the preventive effect of VTE in the prevention and management of postoperative venous thromboembolism (VTE) after colorectal cancer (CRC) surgery in Chinese population, and to determine its application and promotion value. The research results of this project can provide useful reference for optimizing the prevention and management of VTE after CRC operation.
Read the detailed description
This study is a single-center, prospective, observational cohort study. The design and implementation of the whole study were carried out according to the CONSORT principle. The study was conducted at the Department of Gastrointestinal Surgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine, and patients were followed up for 28 days.
Postoperative patients with colorectal cancer who met the criteria were included. All patients were initiated with low molecular weight heparin (nardraparin calcium injection) for drug prophylaxis after surgery. In clinical practice, patients who underwent surgery at different times on the same day received prophylactic administration of low molecular weight heparin at 24h after surgery, forming two cohorts of early initiation (within 24 hours after surgery) and late initiation (beyond 24 hours after surgery). According to the previous clinical data survey in the past year, since the number of operating tables and the end time of surgery are relatively fixed every day, the number of people in each group of early start and late start groups is about 300 per group per year according to the end time of surgery, which basically conforms to the ratio of 1:1.
The dose of low molecular weight heparin (Nardrheparin calcium injection) was 100AxaIU/kg, adjusted according to the patient's body weight, and was administered subcutaneously once a day throughout the patient's hospital stay. All patients underwent color Doppler ultrasound of lower limbs before discharge (7-10 days after surgery) and 28 days after surgery, including screening for thrombus in the proximal deep vein (femoral vein, popliteal vein), distal deep vein (posterior tibial vein, peroneal vein and muscular vein) and venous communication branch. Each enrolled patient will be followed up for 28 days, and all patients will be followed up 28 days after surgery. If the patient is unable to return to the hospital at the scheduled follow-up time point, the patient can be reminded by phone to be admitted for follow-up visit.
- Conditions
- Colorectal Cancer
- Being tested
- Nardraparin calcium injection
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nardraparin calcium injectionDrug
The dose of nardraparin calcium injection is 100AxaIU/kg, adjusted according to the patient's body weight, and is injected subcutaneously once a day
| Study group | Role | What they receive |
|---|---|---|
| Early initiation of drug prophylaxis (within 24 hours after surgery) | Patients who underwent surgery received prophylactic administration of low molecular weight heparin (nardraparin calcium injection) at a time point of 24 hours after surgery，this group carries out early initiation of drug prophylaxis (within 24 hours after surgery) Receives: Drug: Nardraparin calcium injection | |
| Late initiation of drug prophylaxis (24 hours after surgery) | Patients who underwent surgery received prophylactic administration of low molecular weight heparin (nardraparin calcium injection) at a time point of 24 hours after surgery，this group carries out late initiation of drug prophylaxis ( 24 hours after surgery) Receives: Drug: Nardraparin calcium injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
VTE events within 28 days after surgery
Patients were followed up for VTE events, including deep vein thrombosis (DVT) and pulmonary thromboembolism (PE), within 28 days after surgery. Diagnosis of DVT: The lower limb is examined based on clinical symptoms (swelling and pain in the lower limb, tenderness in the back of the lower limb and/or in the inner thigh) and/or by color ultrasound or venography. The diagnosis of PE is based on clinical findings (dyspnea and shortness of breath), laboratory tests (plasma D-dimer), and CT pulmonary angiography (CTPA). Vte events were evaluated at 7 and 28 days after surgery. If a patient develops a VTE event, the patient is treated with VTE and assessed for thrombotic progression by ultrasound in both lower limb veins after 2 weeks.
Measured: 7 and 28 days after surgery
Secondary outcomes (1)
Any bleeding event within 28 days after surgery
Patients were followed up for any bleeding events within 28 days after surgery, including major and minor bleeding events. According to the International Society of Thrombosis and Hemostasis Standards (ISTH standards). All patients were followed up at 1, 7, and 28 days after surgery through inpatient or outpatient follow-up and bleeding investigation.
Measured: 1，7 and 28 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Feb 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 914 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhi-Chun Gu, Principal investigator, Department of Pharmacy, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259149
- Sponsor's protocol ID
- IIT-2023-0295
- Status last verified
- Aug 2024
- First submitted
- 6 Feb 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Initiation Timing of VTE Prevention After Colorectal Cancer Surgery: a Single-center, Prospective, Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06259149
- Acronym / sponsor ID
- IIT-2023-0295
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 914 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project intends to conduct a single-center, prospective, observational cohort study to explore the impact of the timing of drug prophylaxis on the risk of postoperative bleeding and the preventive effect of VTE in the prevention and management of postoperative venous thromboembolism (VTE) after colorectal cancer (CRC) surgery in Chinese population, and to determine its application and promotion value. The research results of this project can provide useful reference for optimizing the prevention and management of VTE after CRC operation.
Detailed description
This study is a single-center, prospective, observational cohort study. The design and implementation of the whole study were carried out according to the CONSORT principle. The study was conducted at the Department of Gastrointestinal Surgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine, and patients were followed up for 28 days.
Postoperative patients with colorectal cancer who met the criteria were included. All patients were initiated with low molecular weight heparin (nardraparin calcium injection) for drug prophylaxis after surgery. In clinical practice, patients who underwent surgery at different times on the same day received prophylactic administration of low molecular weight heparin at 24h after surgery, forming two cohorts of early initiation (within 24 hours after surgery) and late initiation (beyond 24 hours after surgery). According to the previous clinical data survey in the past year, since the number of operating tables and the end time of surgery are relatively fixed every day, the number of people in each group of early start and late start groups is about 300 per group per year according to the end time of surgery, which basically conforms to the ratio of 1:1.
The dose of low molecular weight heparin (Nardrheparin calcium injection) was 100AxaIU/kg, adjusted according to the patient's body weight, and was administered subcutaneously once a day throughout the patient's hospital stay. All patients underwent color Doppler ultrasound of lower limbs before discharge (7-10 days after surgery) and 28 days after surgery, including screening for thrombus in the proximal deep vein (femoral vein, popliteal vein), distal deep vein (posterior tibial vein, peroneal vein and muscular vein) and venous communication branch. Each enrolled patient will be followed up for 28 days, and all patients will be followed up 28 days after surgery. If the patient is unable to return to the hospital at the scheduled follow-up time point, the patient can be reminded by phone to be admitted for follow-up visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early initiation of drug prophylaxis (within 24 hours after surgery) | – | Drug: Nardraparin calcium injectionPatients who underwent surgery received prophylactic administration of low molecular weight heparin (nardraparin calcium injection) at a time point of 24 hours after surgery，this group carries out early initiation of drug prophylaxis (within 24 hours after surgery) |
| Late initiation of drug prophylaxis (24 hours after surgery) | – | Drug: Nardraparin calcium injectionPatients who underwent surgery received prophylactic administration of low molecular weight heparin (nardraparin calcium injection) at a time point of 24 hours after surgery，this group carries out late initiation of drug prophylaxis ( 24 hours after surgery) |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient was diagnosed with colorectal cancer and underwent radical surgery (laparoscopic or open surgery) with an estimated operation time of >45 minutes. Patients with expected survival >6 months after surgery
Key inclusion criteria (3 listed)
- ① Age > 18 years old;
- ② The patient was diagnosed with colorectal cancer, and the cTMN stage was cT1-2, N0 or cT3, N0 or any cT, N1-2; (3) The patient was diagnosed with colorectal cancer and was able to receive radical surgery (laparoscopic or open surgery). The expected operation time was >45 minutes, and the expected postoperative survival time was >6 months.
- ④ The patient or guardian agrees to the study plan and signs the informed consent.
Key exclusion criteria (7 listed)
- ① Renal insufficiency (CrCl<30 mL/min) or hepatic insufficiency (ALT> 3 times the upper limit of normal);
- Known allergy to low molecular weight heparin (LWMH), narcotic drugs or radiocontrast agents; The presence of systemic hemorrhagic disease or bleeding tendency, such as active peptic ulcer, uncontrolled hypertension, cerebral thrombosis, cerebral hemorrhage or neurosurgical history within 6 months;
- known brain metastases, endocarditis, or history of heparin-induced thrombocytopenia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nardraparin calcium injectionThe dose of nardraparin calcium injection is 100AxaIU/kg, adjusted according to the patient's body weight, and is injected subcutaneously once a day | Drug | Early initiation of drug prophylaxis (within 24 hours after surgery), Late initiation of drug prophylaxis (24 hours after surgery) |
Primary outcome
VTE events within 28 days after surgery
Time frame: 7 and 28 days after surgery
Patients were followed up for VTE events, including deep vein thrombosis (DVT) and pulmonary thromboembolism (PE), within 28 days after surgery. Diagnosis of DVT: The lower limb is examined based on clinical symptoms (swelling and pain in the lower limb, tenderness in the back of the lower limb and/or in the inner thigh) and/or by color ultrasound or venography. The diagnosis of PE is based on clinical findings (dyspnea and shortness of breath), laboratory tests (plasma D-dimer), and CT pulmonary angiography (CTPA). Vte events were evaluated at 7 and 28 days after surgery. If a patient develops a VTE event, the patient is treated with VTE and assessed for thrombotic progression by ultrasound in both lower limb veins after 2 weeks.
1 secondary outcome
Any bleeding event within 28 days after surgery
Time frame: 1，7 and 28 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhi-Chun Gu principal investigator
Department of Pharmacy, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by RenJi Hospital at 1 site in China.
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 3 inclusion and 7 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 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Meng Hu, PhD (+8615000090636, humeng@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VTE events within 28 days after surgery (time frame: 7 and 28 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2024.