A Study of Initiation Timing of VTE Prevention After Colorectal Cancer Surgery

NCT06259149 | Recruiting FDA Drug

• 1 other identifier: IIT-2023-0295
• Study Type: observational
• Target: 914
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  7 and 28 days after surgery

Secondary Outcomes (1)

• Any bleeding event within 28 days after surgery

  1，7 and 28 days after surgery

Study Arms (2)

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)

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)

Drug: Nardraparin calcium injection

Interventions

Nardraparin calcium injection DRUG

The dose of nardraparin calcium injection is 100AxaIU/kg, adjusted according to the patient's body weight, and is injected subcutaneously once a day

Early initiation of drug prophylaxis (within 24 hours after surgery); Late initiation of drug prophylaxis (24 hours after surgery)

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Department of Gastrointestinal Surgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Biospecimen

blood and Colorectal cancer tissue

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Zhi-Chun Gu

  Department of Pharmacy, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meng Hu, PhD

CONTACT

+8615000090636; humeng@renji.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: February 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

CN (1)