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

NCT06103214 | Completed DMC

• 1 other identifier: IRB-2015-194
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ovarian Neoplasm Epithelial

Keywords

Acute normovolemic hemodilution (ANH); Acute hypervolemic hemodilution (AHH); Ovarian cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

Control Group

NO INTERVENTION

In control group ，patients had undergone similar surgical and anesthesia procedures in the same time period but whose hemodynamic management was carried out according to the clinical decision of the attending anesthesiologist.

acute normovolemic hemodilution (ANH)

OTHER

Before anesthesia induction, in the ANH Group, blood was withdrawn at a speed of 25-30ml/min from radial artery and stored in standard collection bags.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.

Other: acute normovolemic hemodilution (ANH)

acute hypervolemic hemodilution (AHH)

OTHER

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.

Other: acute hypervolemic hemodilution (AHH)

Interventions

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 normovolemic hemodilution (ANH)

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.

acute hypervolemic hemodilution (AHH)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 23, 2023
• First Posted: October 26, 2023
• Study Start: January 1, 2017
• Primary Completion: May 31, 2022
• Study Completion: January 31, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10