Ovarian Neoplasm EpithelialNCT06103214
The Effects of Hemodilution Methods in Patients Undergoing Primary Debulking Gynaecological Surgery
A study testing acute normovolemic hemodilution (ANH) and acute hypervolemic hemodilution (AHH) in people with Ovarian Neoplasm Epithelial, run by Zhejiang Cancer Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Ovarian Neoplasm Epithelial
- What is being tested?
- acute normovolemic hemodilution (ANH) and acute hypervolemic hemodilution (AHH)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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
- Being tested
- acute normovolemic hemodilution (ANH), acute hypervolemic hemodilution (AHH)
- Keywords
- Acute normovolemic hemodilution (ANH), Acute hypervolemic hemodilution (AHH), Ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: acute hypervolemic hemodilution (AHH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: three periods: before hemodilution, immediate postoperative period, and 24 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Jan 2017
- Primary completion31 May 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Neoplasm EpithelialStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Huidan, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103214
- Sponsor's protocol ID
- IRB-2015-194
- Status last verified
- Oct 2023
- First submitted
- 23 Sep 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Two Hemodilution Methods on Vascular Endothelial Function in Patients Undergoing Primary Debulking Gynaecological Surgery
- ClinicalTrials.gov ID
- NCT06103214
- Acronym / sponsor ID
- IRB-2015-194
- Conditions
- Ovarian Neoplasm Epithelial
- Keywords
- Acute normovolemic hemodilution (ANH), Acute hypervolemic hemodilution (AHH), Ovarian cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | 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. |
| acute hypervolemic hemodilution (AHH) | Other | 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 normovolemic hemodilution (ANH) |
| 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. | Other | acute hypervolemic hemodilution (AHH) |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing acute normovolemic hemodilution (ANH) and acute hypervolemic hemodilution (AHH) in people with Ovarian Neoplasm Epithelial, run by Zhejiang Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelin-1 (ET-1) (time frame: three periods: before hemodilution, immediate postoperative period, and 24 hours later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.