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

October 21, 2023 updated by: Zhou Huidan, Zhejiang Cancer Hospital

The Effects of Two Hemodilution Methods on Vascular Endothelial Function 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: 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.
Other: 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.
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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
three periods: before hemodilution, immediate postoperative period, and 24 hours later

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
three periods: before hemodilution, immediate postoperative period, and 24 hours later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-2015-194

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings