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

Ovarian Neoplasm Epithelial Clinical Trial

Official title:

The Effects of Two Hemodilution Methods on Vascular Endothelial Function in Patients Undergoing Primary Debulking Gynaecological Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06103214
• Other study ID #: IRB-2015-194
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: January 31, 2023

Study information

• Verified date: October 2023
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Ovarian Neoplasm Epithelial
• Ovarian Neoplasms

Intervention

Other:
• acute normovolemic hemodilution (ANH)
Acute normovolemic hemodilution (ANH) is a medical procedure that involves removing a certain volume of blood from a patient before surgery and replacing it with a volume expander or blood substitute. The goal of ANH is to reduce the need for blood transfusions during or after surgery. During the ANH procedure, a patient's blood is typically withdrawn and replaced with a crystalloid or colloid solution. This dilutes the patient's blood, reducing the concentration of red blood cells. The withdrawn blood is then stored and can be reinfused back into the patient after the surgical procedure is completed.
• acute hypervolemic hemodilution (AHH)
The purpose of diluting the blood with fluids and removing some of the red blood cells is to decrease the viscosity of the blood. This can improve blood flow and oxygen delivery to tissues, especially in cases of decreased blood flow or oxygenation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Outcome

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