Epithelial Ovarian CancerNCT01442051
Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer
A study testing Acute Normovolemic Hemodilution in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
Trial summary
The purpose of this study is to help us learn how to lower the risk of a blood transfusion during surgery to remove ovarian cancer. Acute normovolemic hemodilution (ANH) is a technique performed in the operating room before the procedure begins that may reduce the risk of needing a transfusion during ovarian cancer… Read more about this study
- Who is it for?
- Ages 18 to 69 years, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- What is being tested?
- Acute Normovolemic Hemodilution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Sep 2011to 1 Jul 2019
- 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 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study population will include women with a high preoperative suspicion of advanced primary epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (Stage IIIC or IV) as determined by CT or MRI of abdomen and pelvis planning to undergo exploratory laparotomy and surgical cytoreduction with the operative goal of this procedure to achieve optimal cytoreduction to less than 1 cm of residual disease.
- Age ≥ 18 years and < 70 years.
- Preoperative hemoglobin concentration ≥ 10 mg/dL within 30 days of registration.
- Based on surgeon's assessment, patient is recommended to undergo cytoreductive surgery via laparotomy with the operative goal of this procedure to achieve optimal cytoreduction to less than 1 cm of residual disease.
Who cannot join
- Hemoglobin < 10 g/dL.
- Serum albumin < 3g/dL.
- GOG performance status > 2.
- Active coronary artery disease (defined as unstable angina or a positive cardiac stress test).
- Patients with a history of coronary artery disease may be included if they have had a normal cardiac stress test within 30 days of enrollment.
- History of cerebrovascular disease.
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- Renal insufficiency with serum creatinine > 1.6.
- Uncontrolled hypertension.
- Restrictive or obstructive pulmonary disease.
- Congestive heart failure.
- Active infection.
- Pregnancy.
- Refusal to accept allogenic or autologous blood transfusion.
- Autologous blood transfusion within last 30 days or plan to donate autologous blood prior to surgery.
- Plan for exploratory laparoscopy prior to laparotomy for assessment of disease resectability.
- Surgeon has high suspicion (>50% chance) that cytoreductive surgery will be aborted due to inability to achieve optimal cytoreduction to < 1cm residual disease.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan Kettering West Harrison
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Pilot Study of Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer
The purpose of this study is to help us learn how to lower the risk of a blood transfusion during surgery to remove ovarian cancer. Acute normovolemic hemodilution (ANH) is a technique performed in the operating room before the procedure begins that may reduce the risk of needing a transfusion during ovarian cancer surgery. During surgery, the patient's own blood is given back to them when needed, usually due to bleeding. If you don't need blood during surgery, your own blood will be given back at the end of the case.
The idea behind ANH is that that by removing the blood and replacing it with other fluids, the remaining blood becomes diluted. This diluted blood is then lost during surgery, usually due to bleeding. The original non-diluted blood is then transfused back as needed. This may mean a lower chance of needing an additional blood transfusion.
ANH has been studied at this hospital for other types of cancer. These studies suggest that ANH may help conserve blood. Although most studies suggest that ANH can be performed safely, one study showed that ANH could be associated with a higher rate of serious bowel complications than standard treatment. In this study, patients who underwent ANH had a higher rate of anastomotic leaks during bowel surgery. An anastomotic leak occurs when two ends of bowel that have been cut and sewn back together (the anastomosis), fall apart. The investigators don't know whether ANH will result in higher rates of anastomotic leaks in patients having ovarian cancer surgery. In fact, in another study evaluating ANH in patients having the kind of bowel resections that often occur in ovarian cancer surgery (the colon), no increased risk of anastomotic leaks was observed. For these reasons, researchers at MSKCC are conducting a study to find out if ANH can be used safely in patients undergoing surgery for ovarian cancer.
- Being tested
- Acute Normovolemic Hemodilution
- Keywords
- Acute Normovolemic Hemodilution, Cytoreductive Surgery, laparotomy, 11-149, advanced primary epithelial ovarian cancer
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Normovolemic HemodilutionProcedure or surgery
A predetermined volume of whole blood will be removed from these patients based on an established protocol. Crystalloid and colloid will then be infused to replace intravascular volume based on this protocol. Patients will be closely monitored intraoperatively with serum arterial hemoglobin (HgB) levels drawn hourly. Patients will be transfused with autologous blood if HgB < 7.0 g/dL. If the volume of autologous blood has not been transfused within eight hours or by the completion of the procedure, the remainder will be transfused at that time. If the volume of autologous blood has been transfused and the patients require additional blood transfusions (HgB <7g.dL), allogenic blood will be transfused thereafter. These transfusion triggers are based on common intraoperative practice patterns. Patients may also be transfused intraoperatively at any time for a HgB ≥ 7.0 g/dL based on the judgment of the attending anesthesiologist or surgeon but the reason will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Acute Normovolemic Hemodilution | Experimental | A pilot study will be performed. Intraoperative data including vital signs, procedures performed, and transfusions of allogenic blood will be collected prospectively. Postoperative outcomes, including transfusions of allogenic blood, perioperative complications, and 30-day mortality will be collected prospectively. These outcomes will be compared to historical controls to assess for the safety and efficacy of ANH in ovarian cancer cytoreductive surgery. Receives: Procedure: Acute Normovolemic Hemodilution |
What is being measured
The primary outcome is the main question the study is designed to answer.
the safety of performing acute normovolemic hemodilution (ANH)
Allogenic red blood cell transfusion rate will be measured as any transfusion during the operating procedure or during the hospitalization
Measured: within 7 days
Secondary outcomes (4)
impact on transfusion rates
Allogenic red blood cell transfusion rate will be measured as any transfusion during the operating procedure or during the hospitalization. The charts of patients transfused outside of the guidelines will be flagged for auditing and will be reviewed by the PI. Such transfusions will be considered appropriate if a reasonable clinical justification is identified.
Measured: 2 years
length of hospitalization stay
Measured: 2 years
postoperative complications
Careful assessment and recording of all intraoperative and postoperative complications within 30 days of surgery according to universal guidelines as established by the Gynecologic Oncology Group and affirmed by the Division of Gynecology at MSKCC.
Measured: within 30 days of surgery
operating time
operative time will be compared to historical controls that received standard intraoperative management.
Measured: Duration of surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study start23 Sep 2011
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennis Chi, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442051
- Sponsor's protocol ID
- 11-149
- Status last verified
- Jul 2018
- First submitted
- 23 Sep 2011
- Last updated
- 5 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01442051
- Acronym / sponsor ID
- 11-149
- Keywords
- Acute Normovolemic Hemodilution, Cytoreductive Surgery, laparotomy, 11-149, advanced primary epithelial ovarian cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 23 Sep 2011 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 28 Sep 2011 (estimated)
- 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.
The purpose of this study is to help us learn how to lower the risk of a blood transfusion during surgery to remove ovarian cancer. Acute normovolemic hemodilution (ANH) is a technique performed in the operating room before the procedure begins that may reduce the risk of needing a transfusion during ovarian cancer surgery. During surgery, the patient's own blood is given back to them when needed, usually due to bleeding. If you don't need blood during surgery, your own blood will be given back at the end of the case.
The idea behind ANH is that that by removing the blood and replacing it with other fluids, the remaining blood becomes diluted. This diluted blood is then lost during surgery, usually due to bleeding. The original non-diluted blood is then transfused back as needed. This may mean a lower chance of needing an additional blood transfusion.
ANH has been studied at this hospital for other types of cancer. These studies suggest that ANH may help conserve blood. Although most studies suggest that ANH can be performed safely, one study showed that ANH could be associated with a higher rate of serious bowel complications than standard treatment. In this study, patients who underwent ANH had a higher rate of anastomotic leaks during bowel surgery. An anastomotic leak occurs when two ends of bowel that have been cut and sewn back together (the anastomosis), fall apart. The investigators don't know whether ANH will result in higher rates of anastomotic leaks in patients having ovarian cancer surgery. In fact, in another study evaluating ANH in patients having the kind of bowel resections that often occur in ovarian cancer surgery (the colon), no increased risk of anastomotic leaks was observed. For these reasons, researchers at MSKCC are conducting a study to find out if ANH can be used safely in patients undergoing surgery for ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Normovolemic Hemodilution | Experimental | Procedure: Acute Normovolemic HemodilutionA pilot study will be performed. Intraoperative data including vital signs, procedures performed, and transfusions of allogenic blood will be collected prospectively. Postoperative outcomes, including transfusions of allogenic blood, perioperative complications, and 30-day mortality will be collected prospectively. These outcomes will be compared to historical controls to assess for the safety and efficacy of ANH in ovarian cancer cytoreductive surgery. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The study population will include women with a high preoperative suspicion of advanced primary epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (Stage IIIC or IV) as determined by CT or MRI of abdomen and pelvis planning to undergo exploratory laparotomy and surgical cytoreduction with the operative goal of this procedure to achieve optimal cytoreduction to less than 1 cm of residual disease.
- Age ≥ 18 years and < 70 years.
- Preoperative hemoglobin concentration ≥ 10 mg/dL within 30 days of registration.
- Based on surgeon's assessment, patient is recommended to undergo cytoreductive surgery via laparotomy with the operative goal of this procedure to achieve optimal cytoreduction to less than 1 cm of residual disease.
Key exclusion criteria (16 listed)
- Hemoglobin < 10 g/dL.
- Serum albumin < 3g/dL.
- GOG performance status > 2.
- Active coronary artery disease (defined as unstable angina or a positive cardiac stress test).
- Patients with a history of coronary artery disease may be included if they have had a normal cardiac stress test within 30 days of enrollment.
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 HemodilutionA predetermined volume of whole blood will be removed from these patients based on an established protocol. Crystalloid and colloid will then be infused to replace intravascular volume based on this protocol. Patients will be closely monitored intraoperatively with serum arterial hemoglobin (HgB) levels drawn hourly. Patients will be transfused with autologous blood if HgB < 7.0 g/dL. If the volume of autologous blood has not been transfused within eight hours or by the completion of the procedure, the remainder will be transfused at that time. If the volume of autologous blood has been transfused and the patients require additional blood transfusions (HgB <7g.dL), allogenic blood will be transfused thereafter. These transfusion triggers are based on common intraoperative practice patterns. Patients may also be transfused intraoperatively at any time for a HgB ≥ 7.0 g/dL based on the judgment of the attending anesthesiologist or surgeon but the reason will be recorded. | Procedure or surgery | Acute Normovolemic Hemodilution |
Primary outcome
the safety of performing acute normovolemic hemodilution (ANH)
Time frame: within 7 days
Allogenic red blood cell transfusion rate will be measured as any transfusion during the operating procedure or during the hospitalization
4 secondary outcomes
impact on transfusion rates
Time frame: 2 years
length of hospitalization stay
Time frame: 2 years
postoperative complications
Time frame: within 30 days of surgery
operating time
Time frame: Duration of surgical procedure
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 5 Jul 2019.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Dennis Chi, MD principal investigator
Memorial Sloan Kettering Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Normovolemic Hemodilution in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
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 4 inclusion and 16 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 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
the safety of performing acute normovolemic hemodilution (ANH) (time frame: within 7 days). 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 5 Jul 2019.