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

NCT ID: NCT06103214

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2023-01-31

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.

Conditions

Ovarian Neoplasm Epithelial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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Before anesthesia induction, in the ANH Group, blood was withdrawn at a speed of 25-30ml/min from radial artery and stored in standard collection bags.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

Group Type: OTHER

acute normovolemic hemodilution (ANH)

Intervention Type: 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)

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.

Group Type: OTHER

acute hypervolemic hemodilution (AHH)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhou Huidan

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IRB-2015-194

Identifier Type: -

Identifier Source: org_study_id