Autologous Platelet-rich Plasma (PRP) and Thrombin Coagulum for the Topical Treatment of Rectal Mucosal Ulcers

Launched by XIJING HOSPITAL OF DIGESTIVE DISEASES · Jun 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a treatment called autologous platelet-rich plasma (PRP) gel for patients with moderate to severe ulcerative colitis (UC) who have rectal ulcers. UC is a long-lasting condition that causes inflammation and ulcers in the large intestine, leading to symptoms like abdominal pain and diarrhea. The goal of this study is to find out if PRP gel can help heal these ulcers and improve patients' quality of life.

To participate in the trial, patients need to be diagnosed with moderate to severe UC and must have certain blood levels as well as specific scores indicating the severity of their condition. Participants will receive PRP treatments and will be monitored for their safety and the effectiveness of the treatment. This trial is important because there are currently few options for treating rectal ulcers in UC patients, and the results could provide a new way to help those suffering from this challenging disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Platelet ≥150×10\^9g/L, hemoglobin ≥60g/L;
• • 2. Patients with ulcerative colitis were diagnosed according to the diagnostic criteria of ulcerative colitis in the 2018 China's National consensus on the diagnosis and treatment of inflammatory bowel disease;
• • 3. Patients with moderate to severe ulcerative colitis involving the rectum or refractory distal rectal ulcerative colitis (modified Mayo score ≥6 and endoscopic Mayo score ≥2);
• • 4. Patients with ulcerative colitis who were initially treated with infliximab (according to a regular intravenous infusion schedule of 0w, 2w, 6w, and then every 8w);
• • 5. Patients who were able and willing to adhere to the study protocol provided signed, dated, written informed consent.
• Exclusion Criteria:
• • 1. Patients with platelet-related bleeding diseases (such as Henoch-Schonlein purpura, coagulopathy, primary/secondary thrombocytopenia, etc.);
• • 2. Medications with anticoagulant effects such as nonsteroidal anti-inflammatory drugs, heparin, coumarin, warfarin, aspirin, etc. (acetaminophen was used to treat discomfort during the study period);
• • 3. Patients using mesalazine enema solution during treatment;
• • 4. Patients with active infection of intestinal or other extra-intestinal organs (hepatitis, active tuberculosis, etc.);
• • 5. Patients with known hypersensitivity to calcium gluconate and thrombin
• • 6. Patients who may require immediate surgical treatment;
• • 7. Pregnant or nursing mothers;
• • 8. Patients with severe liver and kidney dysfunction, heart failure or other serious systemic diseases;
• • 9. Any conditions that prevent the completion of the study or interfere with the analysis of the study results, including drug or alcohol abuse history, smoking abstinence, mental illness or poor compliance, and clear immune system (including HIV infection), blood system or cancer related diseases;
• • 10. Patients who withdraw consent;
• • 11. Patients enrolled in other clinical trials within 3 months prior to screening.