The Effects of Hemodilution Methods in Patients Undergoing Primary Debulking Gynaecological Surgery

Not Applicable

Completed

• Conditions: Ovarian Neoplasm Epithelial
• Interventions: Other: acute normovolemic hemodilution (ANH); Other: acute hypervolemic hemodilution (AHH)

• Registration Number: NCT06103214
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

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.

Detailed Description

Using a computer-generated random number table, patients were randomized to three groups: Control Group(n=30), ANH Group(n=30) and AHH Group(n=30). Patients underwent standard preoperative preparation for cytoreductive surgery according to institutional standards.All patients who underwent a standard anesthesia protocol and similar surgical procedures were considered for the analysis. For this purpose, investigators only included patients who underwent the following interventions: radical hysterectomy, bilateral adnexectomy, one or more bowel resection, peritonectomy, pelvic lymphadenectomy and extended periaortic lymphadenectomy. The patient would be ruled out of the experiment when the participant was accompanied with any kind of serious complications such as wakening delay and drug allergy.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2022-05-31
• Study Completion: 2023-01-31
• Study First Submitted: 2023-09-23
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-21
• Last Update Submitted: 2023-10-21
• Study First Posted: 2023-10-26
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acute normovolemic hemodilution (ANH)	acute normovolemic hemodilution (ANH)	Before anesthesia induction, in the ANH Group, blood was withdrawn at a speed of 25-30ml/min from radial artery and stored in standard collection bags. The volume of blood to be removed during ANH was calculated using an established formula as follows: V = EBV (H0 - Ht) / H. During collection, a tilt rocker scale was used to rock, mix, and weigh the blood. To maintain euvolemia, half of the blood volume removed was replaced with 6% hydroxyethyl starch 130/0.4 with medium molecular weight at a 1:1 ratio and half was replaced with crystalloid at a 1:2 ratio. The autologous blood was returned to patients if the intraoperative transfusion trigger (Hb \<8.0g/dl) was reached or at the completion of the operation.
acute hypervolemic hemodilution (AHH)	acute hypervolemic hemodilution (AHH)	In AHH group, 15ml/kg Voluven was transfused at a speed of 30 ml/min to make Hct to drop to medium. In control group, the regular transfusion and infusion were conducted. Allogenic blood was only given after all autologous blood had been returned to the patient. The transfusion triggers (Hb \<8.0g/dl) were used to determine the need for allogenic blood transfusions during the procedure in three groups.

Primary Outcome Measures

Name	Time	Method
Endothelin-1 (ET-1)	three periods: before hemodilution, immediate postoperative period, and 24 hours later	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.

Secondary Outcome Measures

Name	Time	Method
von Willebrand factor (VWF), tissue factor pathway inhibitor (TFPI), plasminogen activator inhibitor 1 (PAI-1) and thrombomodulin (TM) levels	three periods: before hemodilution, immediate postoperative period, and 24 hours later	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.