A Multicenter, Open-Label, Non-Inferiority Randomized Controlled Trial of Postoperative VTE Prevention in Chinese Patients After Colorectal Cancer Surgery

Launched by BEIJING FRIENDSHIP HOSPITAL · Sep 1, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to improve how we prevent blood clots, known as venous thromboembolism (VTE), in patients who have just undergone surgery for colorectal cancer. The study aims to find out if a shorter treatment period with a medication called low molecular weight heparin (given as a daily injection) is just as effective as the standard longer treatment. Participants will begin receiving this medication within 24 hours after their surgery, with one group taking it for 14 days and another for 28 days. Throughout the study, doctors will use ultrasound tests to check for any signs of blood clots in the legs.

To participate in this trial, individuals must be at least 18 years old and diagnosed with colorectal cancer, planning to have surgery that lasts more than 45 minutes. They should be expected to live for at least six months after the surgery. However, certain medical conditions, like severe kidney or liver issues, allergies to the medication, or a history of bleeding disorders, would exclude someone from participating. This trial is not yet recruiting participants, but it represents an important step towards improving patient care after colorectal surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age\>18 years old; Diagnosed with colorectal cancer and undergoing curative, palliative, or other limited surgeries (laparoscopic or open surgery), with an estimated surgery time of\>45 minutes; Expected postoperative survival\>6 months; Expected Caprini score of ≥ 5 on the first day after surgery; The patient agrees to the research plan and signs an informed consent form.
• Exclusion Criteria:
• • Renal dysfunction (CrCl\<30 mL/min) or liver dysfunction (ALT\>3 times the upper limit of normal); Known allergies to LMWH, anesthetics, or contrast agents; There is a systemic bleeding disorder or bleeding tendency, such as active peptic ulcer, uncontrolled hypertension, cerebral thrombosis within 6 months, cerebral hemorrhage, or a history of neurosurgical surgery; Known brain metastases, endocarditis, or previous heparin induced thrombocytopenia; VTE occurred within 3 months before surgery; Use heparin or oral anticoagulant therapy within 5 days before surgery; Pregnant or lactating women; Pregnant or lactating women; Any conditions that researcher determines the subject not suitable for anticoagulant therapy.