Ovarian Neoplasm Epithelial Clinical Trial
Official title:
The Effects of Two Hemodilution Methods on Vascular Endothelial Function in Patients Undergoing Primary Debulking Gynaecological Surgery
Verified date | October 2023 |
Source | Zhejiang Cancer Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Primary cytoreductive surgery for ovarian cancer is an ideal setting to evaluate endothelial function under ANH and AHH, as the procedure is associated with moderately high blood loss. As the technique has not yet been described in this setting, investigators designed a pilot study to evaluate ANH and AHH in patients planned to undergo primary cytoreduction during perioperative period, with the intent of proceeding to a randomized trial if results were favorable.
Status | Completed |
Enrollment | 144 |
Est. completion date | January 31, 2023 |
Est. primary completion date | May 31, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Clinical diagnosis of advanced primary epithelial ovarian 2. No comorbidities nor functional limitations (ASA Grade II due to high tumor load) 3. Serum hemoglobin (Hb) before surgery = 11g/dl 4. Hematocrit (Hct) = 35% 5. Quantity of platelets = 100 × 109 /L Exclusion Criteria: 1. Age <18 or >65 years 2. Body mass index <20 and >30 kg/m2 3. Duration of surgery <180 min 4. Severe cardiovascular disease, liver and kidney disease 5. Thromboembolism history |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Zhejiang Cancer Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Endothelin-1 (ET-1) | Blood sample (5 ml) was obtained from the vein,Endothelin-1 (ET-1) was measured using the enzyme-linked immunosorbent assay (ELISA) (Merck & Co Inc, USA) according to manufacturer's instructions. | three periods: before hemodilution, immediate postoperative period, and 24 hours later | |
Secondary | von Willebrand factor (VWF), tissue factor pathway inhibitor (TFPI), plasminogen activator inhibitor 1 (PAI-1) and thrombomodulin (TM) levels | von Willebrand factor (VWF), tissue factor pathway inhibitor (TFPI), plasminogen activator inhibitor 1 (PAI-1) and thrombomodulin (TM) levels were measured using the enzyme-linked immunosorbent assay (ELISA) (Merck & Co Inc, USA) according to manufacturer's instructions. | three periods: before hemodilution, immediate postoperative period, and 24 hours later |
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