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

University of Chinese Academy Sciences

Status: Completed

Conditions: Ovarian Neoplasm Epithelial

Treatments: Other: acute normovolemic hemodilution (ANH); Other: acute hypervolemic hemodilution (AHH)

Study type: Interventional

Funder types: Other

Identifiers

NCT06103214

IRB-2015-194

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 3 patient groups

Control Group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: acute normovolemic hemodilution (ANH)

acute hypervolemic hemodilution (AHH)

Other group

Description:

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.

Treatment:

Other: acute hypervolemic hemodilution (AHH)