ISRCTN19517317
Completed
未知
A randomised controlled feasibility Trial of Intraoperative Cell salvage vs donor blood Transfusion in Ovarian Cancer surgery (TICTOC)
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Specialty: Cancer, Primary sub-specialty: Gynae
- Sponsor
- Royal Cornwall Hospitals NHS Trust
- Enrollment
- 57
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30389760 protocol (added 01/11/2019)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. 18 years old or over
- •2\. Suspected or confirmed ovarian cancer (newly diagnosed) requiring cytoreductive surgery, whether primary or interval (following chemotherapy)
- •3\. CT scan evidence (with or without clinical evidence) compatible with FIGO stage III/IV ovarian cancer/ primary peritoneal cancer at presentation\*
- •4\. ECOG Performance Status 0\-1
- •5\. Willing to participate and able to give written informed consent
- •\*CT features of pelvic mass (or features suggestive of primary peritoneal cancer) and extrapelvic involvement including ascites, omental disease, peritoneal thickening, bowel surface and/or mesentery involvement, enlarged pelvic and para\-aortic lymph nodes, evidence of disease on diaphragm
Exclusion Criteria
- •1\. Diagnosis of concurrent malignancy
- •2\. Pregnant
- •3\. Donor transfusion during the week prior to surgery
- •4\. Haemoglobinopathies (e.g. sickle cell, thalassaemia)
- •5\. Unwilling to accept donor blood (e.g. on religious grounds)
Outcomes
Primary Outcomes
Not specified
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