Skip to main content
OpenTrials
Completed

NCT Number: NCT06103214

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ovarian Neoplasm Epithelial Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of advanced primary epithelial ovarian
  • No comorbidities nor functional limitations (ASA Grade II due to high tumor load)
  • Serum hemoglobin (Hb) before surgery ≥ 11g/dl
  • Hematocrit (Hct) ≥ 35%
  • Quantity of platelets ≥ 100 × 109 /L

Exclusion criteria

  • Age <18 or >65 years
  • Body mass index <20 and >30 kg/m2
  • Duration of surgery <180 min
  • Severe cardiovascular disease, liver and kidney disease
  • Thromboembolism history

Treatment and study plan

acute normovolemic hemodilution (ANH)

Other

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)

Other

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.

Primary outcomes

  1. Endothelin-1 (ET-1)

    Time frame: 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 outcomes

  1. von Willebrand factor (VWF), tissue factor pathway inhibitor (TFPI), plasminogen activator inhibitor 1 (PAI-1) and thrombomodulin (TM) levels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Oct 26, 2023
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.