Peripartum AnemiaNCT06240117
Impact of Intraoperative Cell Salvage
A study testing Intraoperative cellular salvage in people with Peripartum Anemia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Patients presenting for elective cesarean section will be screened for pre-procedural anemia. If the potential subject meets the selection criteria they will be presented with the option of participating in the study. Once consented the participant is randomized by envelope. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Peripartum Anemia
- What is being tested?
- Intraoperative cellular salvage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2024to 25 Jun 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18-55 years.
- Presenting for elective cesarean section.
- With hemoglobin less or equal to 11 mg/dL.
- Able to provide informed written consent.
Who cannot join
- Refusal of blood product administration.
- Refusal of intraoperative blood salvage.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Intraoperative Cell Salvage on Maternal Hemoglobin, Need for Allogeneic Blood Transfusion and Recovery Time in Women Presenting With Preoperative Moderate Anemia Undergoing Elective Cesarian Section
Patients presenting for elective cesarean section will be screened for pre-procedural anemia. If the potential subject meets the selection criteria they will be presented with the option of participating in the study. Once consented the participant is randomized by envelope. The two groups studied are: standard of care with intraoperative cell salvage and standard of care without cell salvage. If the participant is randomized to the cell salvage group, the study team will notify the anesthesia and obstetrics (OB) team and will set up the cell salvage system per protocol. The primary end point is to determine the difference in postoperative hemoglobin at 48hrs, need and quantity of allogeneic blood product transfusion, length of hospital stay between the two groups studied. The secondary endpoints Investigate the impact of using IOCS on clinical parameters associated with maternal postpartum stability and well being and include estimation of blood loss, need for pressors, uterotonics, return to the operating room, uterine compression devices, ICU admission, postoperative blood product transfusion, IV iron supplementation, blood chemistry, coagulation parameters, oliguria, diagnosis of acute kidney injury, postoperative dialysis, acute respiratory distress syndrome, pulmonary edema, pneumonia, deep vein thrombosis, pulmonary embolism, oxygen requirement, new arrythmias APGAR scores, anemia fatigue scale at 24hr and 48 hrs, OBSQOR10 score 24 hours and 48 hours postpartum and 6 week postpartum EPDS score.
- Conditions
- Peripartum Anemia
- Being tested
- Intraoperative cellular salvage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative cellular salvageProcedure or surgery
When the patient is randomized to this intervention the cell salvage machine will be set up for intraoperative use. The surgical team will collect blood from the surgical field into the cell salvage machine, which will process the blood for reinfusion. The volume of blood available for reinfusion is determined by the amount of blood lost which can be collected into the cell salvage system. The blood collected into the salvage system will be collected and processed per standard operating room procedure. At least 100mL of blood collected in the system are necessary for processing. If >100mLs are collected, they will be processed and reinfused. The need for additional blood products and medications will be determined by the anesthesiology team based on the patient's hemodynamic status and will proceed per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care with intraoperative cell salvage | Experimental | Participants for elective surgery with anemia randomized to standard of care with intraoperative cell salvage. Receives: Procedure: Intraoperative cellular salvage |
| Standard of care without intraoperative cell salvage | No intervention | Standard of care for cesarean sections as per the policy of the anesthesiology department. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in postoperative hemoglobin at 48hrs compared to preoperative baseline
The difference in postoperative hemoglobin at 48hrs
Measured: Baseline and 48 hours postoperatively
Number of participants requiring allogeneic blood product transfusions
Need of allogeneic blood product transfusions
Measured: at hospital discharge, likely within 120 hours from admission
Quantity of allogeneic blood product transfusion in number of packed red blood cells transfused
Quantity of allogeneic blood product transfusion
Measured: at hospital discharge, likely within 120 hours from admission
Total blood volume transfused
Total blood volume transfused
Measured: at hospital discharge, likely within 120 hours from admission
Length of hospital stay
Length of hospital stay
Measured: at hospital discharge, likely within 120 hours from admission
Secondary outcomes (18)
Quantitative blood loss
The quantitative blood loss is obtained from the measured blood lost and accumulated into the measuring devices such as suction canisters and cell saver machine available in the operating room.
Measured: within 30 minutes of the end of the surgical procedure (approximately 2 hours)
Number of participants being administered uterotonics
Uterotonic use is documented by the anesthesiologist when given intraoperatively. They include oxytocin, misoprostol, methylergonovine and carboprost.
Measured: within 30 minutes of the end of the surgical procedure (approximately 2 hours)
Time to first dosage of pressors
When low blood pressure is measured postoperatively, pressors may be needed for hemodynamic stability. Possible blood pressors used postoperatively include phenylephrine, ephedrine, norepinephrine and epinephrine. The timing will be recorded.
Measured: Until hospital discharge, likely within 120 hours from admission
APGAR Scores
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. APGAR scores will be obtained at 1 minute post-delivery.
Measured: at 1 minute post-delivery
APGAR Scores
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low.
APGAR scores will be obtained at 5 minutes post-delivery.
Measured: at 5 minutes post-delivery
Anemia-Fatigue Scale (FACIT-F) Score
The anemia-fatigue scale (FACIT-F) is a 40-item measure that assesses self-reported fatigue and its impact upon daily activities and function. Each item is measured on a Likert scale which ranges from 1-5. The overall score ranges from 0-160, a higher score indicates greater quality of life.
Measured: at 24 hours postpartum
Anemia-Fatigue Scale (FACIT-F) Score
The anemia-fatigue scale (FACIT-F) is a 40-item measure that assesses self-reported fatigue and its impact upon daily activities and function. Each item is measured on a Likert scale which ranges from 1-5. The overall score ranges from 0-160, a higher score indicates greater quality of life.
Measured: at 48 hours postpartum
The Obstetric Quality of Recovery-10 (OBSQOR-10) Score
The Obstetric Quality of Recovery-10 patient-reported outcome measure (OBSQOR-10) at 24 hours postpartum is a validated tool for assessing the quality of postpartum recovery. Consists of 10 questions with a scale that ranges from 1-10.
Measured: at 24 hours postpartum
The Obstetric Quality of Recovery-10 (OBSQOR-10) Score
The Obstetric Quality of Recovery-10 patient-reported outcome measure (OBSQOR-10) at 48 hours postpartum is a validated tool for assessing the quality of postpartum recovery. Consists of 10 questions with a scale that ranges from 1-10.
Measured: at 48 hours postpartum
The Edinburgh Postnatal Depression Scale (EPDS) Score
The Edinburgh Postnatal Depression Scale (EPDS) is a short 10-item self-report questionnaire designed to identify mothers at risk for prenatal and postnatal depression will be performed at 6 weeks postpartum. Scores are between 0 and 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder.
Measured: Up to 6 weeks postpartum
Use of postoperative uterine compression devices
In cases of postoperative bleeding, uterine compression devices may be needed. The use will be recorded.
Measured: Until hospital discharge, likely within 120 hours from admission
Timing of postoperative uterine compression devices
In cases of postoperative bleeding, uterine compression devices may be needed. The timing will be recorded.
Measured: Until hospital discharge, likely within 120 hours from admission
Use of postoperative blood product transfusion
Blood products may be needed postoperatively depending on patient symptoms and laboratory values. The timing of postoperative blood product transfusion will be recorded in relation to the end of procedure time. Possible blood products include packed red blood cells, platelets, fresh frozen plasma and cryoprecipitate.
Measured: Until hospital discharge, likely within 120 hours from admission
Amount of postoperative blood product transfusion
Blood products may be needed postoperatively depending on patient symptoms and laboratory values. The amount of postoperative blood product transfusion will be recorded. Possible blood products include packed red blood cells, platelets, fresh frozen plasma and cryoprecipitate. Will be reported as number of units.
Measured: Until hospital discharge, likely within 120 hours from admission
Number of participants receiving postoperative intravenous iron
Intravenous iron is used in some cases of postoperative anemia. The number of participants receiving postoperative intravenous iron will be recorded.
Measured: Until hospital discharge, likely within 120 hours from admission
Number of participants admitted to intensive care unit (ICU)
When a higher level of care is needed that which can be provided on the post-operative labor and delivery floor, intensive care unit (ICU) admission may be required. The number of participants requiring ICU admission will be recorded.
Measured: Until hospital discharge, likely within 120 hours from admission
The timing for intensive care unit (ICU)
When a higher level of care is needed that that which can be provided on the post-operative labor and delivery floor, intensive care unit (ICU) admission may be required. The timing for ICU admission will be recorded.
Measured: Until hospital discharge, likely within 120 hours from admission
Reason for intensive care unit (ICU)
When a higher level of care is needed that that which can be provided on the post-operative labor and delivery floor, intensive care unit (ICU) admission may be required. The reason for ICU admission will be recorded.
Measured: Until hospital discharge, likely within 120 hours from admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start11 Mar 2024
- Primary completion25 Jun 2025
- Study completion25 Jun 2025
Why it stopped: Under enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripartum AnemiaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Katz, Icahn School of Medicine at Mount Sinai
- Investigators
- Daniel Katz, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240117
- Sponsor's protocol ID
- STUDY-23-01380
- Status last verified
- Jun 2025
- First submitted
- 25 Jan 2024
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intraoperative Cell Salvage on Maternal Hemoglobin, Need for Allogeneic Blood Transfusion and Recovery Time in Women Presenting With Preoperative Moderate Anemia Undergoing Elective Cesarian Section
- ClinicalTrials.gov ID
- NCT06240117
- Acronym / sponsor ID
- STUDY-23-01380
- Conditions
- Peripartum Anemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Under enrollment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 2 Feb 2024 (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.
Patients presenting for elective cesarean section will be screened for pre-procedural anemia. If the potential subject meets the selection criteria they will be presented with the option of participating in the study. Once consented the participant is randomized by envelope. The two groups studied are: standard of care with intraoperative cell salvage and standard of care without cell salvage. If the participant is randomized to the cell salvage group, the study team will notify the anesthesia and obstetrics (OB) team and will set up the cell salvage system per protocol. The primary end point is to determine the difference in postoperative hemoglobin at 48hrs, need and quantity of allogeneic blood product transfusion, length of hospital stay between the two groups studied. The secondary endpoints Investigate the impact of using IOCS on clinical parameters associated with maternal postpartum stability and well being and include estimation of blood loss, need for pressors, uterotonics, return to the operating room, uterine compression devices, ICU admission, postoperative blood product transfusion, IV iron supplementation, blood chemistry, coagulation parameters, oliguria, diagnosis of acute kidney injury, postoperative dialysis, acute respiratory distress syndrome, pulmonary edema, pneumonia, deep vein thrombosis, pulmonary embolism, oxygen requirement, new arrythmias APGAR scores, anemia fatigue scale at 24hr and 48 hrs, OBSQOR10 score 24 hours and 48 hours postpartum and 6 week postpartum EPDS score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care with intraoperative cell salvage | Experimental | Procedure: Intraoperative cellular salvageParticipants for elective surgery with anemia randomized to standard of care with intraoperative cell salvage. |
| Standard of care without intraoperative cell salvage | No intervention | –Standard of care for cesarean sections as per the policy of the anesthesiology department. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged 18-55 years.
- Presenting for elective cesarean section.
- With hemoglobin less or equal to 11 mg/dL.
- Able to provide informed written consent.
Key exclusion criteria (2 listed)
- Refusal of blood product administration.
- Refusal of intraoperative blood salvage.
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 |
|---|---|---|
| Intraoperative cellular salvageWhen the patient is randomized to this intervention the cell salvage machine will be set up for intraoperative use. The surgical team will collect blood from the surgical field into the cell salvage machine, which will process the blood for reinfusion. The volume of blood available for reinfusion is determined by the amount of blood lost which can be collected into the cell salvage system. The blood collected into the salvage system will be collected and processed per standard operating room procedure. At least 100mL of blood collected in the system are necessary for processing. If >100mLs are collected, they will be processed and reinfused. The need for additional blood products and medications will be determined by the anesthesiology team based on the patient's hemodynamic status and will proceed per standard of care. | Procedure or surgery | Standard of care with intraoperative cell salvage |
Primary outcome
The difference in postoperative hemoglobin at 48hrs compared to preoperative baseline
Time frame: Baseline and 48 hours postoperatively
The difference in postoperative hemoglobin at 48hrs
Number of participants requiring allogeneic blood product transfusions
Time frame: at hospital discharge, likely within 120 hours from admission
Need of allogeneic blood product transfusions
Quantity of allogeneic blood product transfusion in number of packed red blood cells transfused
Time frame: at hospital discharge, likely within 120 hours from admission
Quantity of allogeneic blood product transfusion
Total blood volume transfused
Time frame: at hospital discharge, likely within 120 hours from admission
Total blood volume transfused
Length of hospital stay
Time frame: at hospital discharge, likely within 120 hours from admission
Length of hospital stay
18 secondary outcomes
Quantitative blood loss
Time frame: within 30 minutes of the end of the surgical procedure (approximately 2 hours)
Number of participants being administered uterotonics
Time frame: within 30 minutes of the end of the surgical procedure (approximately 2 hours)
Time to first dosage of pressors
Time frame: Until hospital discharge, likely within 120 hours from admission
APGAR Scores
Time frame: at 1 minute post-delivery
APGAR Scores
Time frame: at 5 minutes post-delivery
Anemia-Fatigue Scale (FACIT-F) Score
Time frame: at 24 hours postpartum
Anemia-Fatigue Scale (FACIT-F) Score
Time frame: at 48 hours postpartum
The Obstetric Quality of Recovery-10 (OBSQOR-10) Score
Time frame: at 24 hours postpartum
The Obstetric Quality of Recovery-10 (OBSQOR-10) Score
Time frame: at 48 hours postpartum
The Edinburgh Postnatal Depression Scale (EPDS) Score
Time frame: Up to 6 weeks postpartum
Use of postoperative uterine compression devices
Time frame: Until hospital discharge, likely within 120 hours from admission
Timing of postoperative uterine compression devices
Time frame: Until hospital discharge, likely within 120 hours from admission
Use of postoperative blood product transfusion
Time frame: Until hospital discharge, likely within 120 hours from admission
Amount of postoperative blood product transfusion
Time frame: Until hospital discharge, likely within 120 hours from admission
Number of participants receiving postoperative intravenous iron
Time frame: Until hospital discharge, likely within 120 hours from admission
Number of participants admitted to intensive care unit (ICU)
Time frame: Until hospital discharge, likely within 120 hours from admission
The timing for intensive care unit (ICU)
Time frame: Until hospital discharge, likely within 120 hours from admission
Reason for intensive care unit (ICU)
Time frame: Until hospital discharge, likely within 120 hours from admission
Results and safety
The study was stopped early (reason given: Under enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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.
Daniel Katz, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative cellular salvage in people with Peripartum Anemia, run by Icahn School of Medicine at Mount Sinai at 1 site 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 2 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: stopped early, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Under enrollment). Results are not available in the source record.
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 difference in postoperative hemoglobin at 48hrs compared to preoperative baseline (time frame: Baseline and 48 hours postoperatively). The study lists 5 primary outcomes in all. 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 2 Jul 2025.