Obstetric HemostasisNCT07466719
Comparison of Efficacy and Safety of Manual Syringing Versus Pneumatic Pressure Bag for Blood Transfusion in Patients Undergoing Cesarean Section With Major Obstetric Hemorrhage
A study testing Manual syringing and pneumatic pressure bag in people with Obstetric Hemostasis and Intravascular Hemolysis, run by Aswan University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare the safety and efficacy of manual syringing versus pneumatic pressure bags for blood transfusion in patients experiencing major obstetric hemorrhage during a cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Obstetric Hemostasis, Intravascular Hemolysis, Major Obstetric Hemorrhage
- What is being tested?
- Manual syringing and pneumatic pressure bag
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-45 years undergoing cesarean section
- Diagnosed major obstetric hemorrhage (blood loss ≥1000 mL or hemodynamic instability requiring transfusion)
- Written informed consent for participation
Who cannot join
- Pre-existing hemolytic conditions (e.g., sickle cell disease, thalassemia)
- Known hypersensitivity to blood products
- Severe baseline coagulopathy (defined as INR > 2.0 or Platelet count < 50,000/mm³) or established disseminated intravascular coagulation (DIC) prior to randomization
- Refusal to receive blood transfusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Soudy Hammad, lecturer of anesthesia,SICU, contact
Egypt1 site, 1 recruiting
- Recruiting
Aswan University Hospital
Aswān
Soudy Hammad, Lecturer, +201014761523, soudi.salah@aswu.edu.eg
About this study
The goal of this clinical trial is to compare the safety and efficacy of manual syringing versus pneumatic pressure bags for blood transfusion in patients experiencing major obstetric hemorrhage during a cesarean section. It will also evaluate the effectiveness of these methods in rapidly stabilizing patient vital signs. The main questions it aims to answer are:Does manual syringing result in a higher incidence of hemolysis (red blood cell destruction) compared to pneumatic pressure bags?Which method is more effective and faster at achieving hemodynamic stability (restoring normal blood pressure, heart rate, and oxygen levels)?Are there differences between the two methods regarding total blood product usage, transfusion-related complications, and the length of hospital stay?Researchers will compare manual syringing (using 20 mL syringes) to pneumatic pressure bags (inflated to 300 mmHg) to determine which is safer and more efficient for emergency transfusions in resource-constrained environments.Participants will:Be women aged 18-45 years undergoing a cesarean section who are diagnosed with major obstetric hemorrhage (blood loss >1000 mL or hemodynamic instability).Be randomly assigned to one of two groups to receive their blood transfusion through either the manual syringe method or a pneumatic pressure bag.Receive standard vascular access through multiple peripheral and jugular cannulae.Undergo close monitoring of vital signs to determine the time to stabilization.Provide blood samples at baseline and six hours post-transfusion to measure markers of hemolysis, specifically Lactate Dehydrogenase (LDH) and indirect bilirubin levels.Be monitored for any transfusion-related complications, such as allergic reactions or acute kidney injury, during their hospital stay and for major complications up to 30 days postoperatively
Read the detailed description
This prospective, single-center, randomized controlled clinical trial (Phase III) is designed to evaluate and compare two common methods for rapid blood transfusion-manual syringing and pneumatic pressure bags-in the specific context of major obstetric hemorrhage (MOH) during cesarean sections. The study is conducted at Aswan University Hospital in Egypt, where both techniques are currently employed in emergency settings, yet a systematic evaluation of their relative safety and clinical efficacy is lacking.Background and RationaleMajor obstetric hemorrhage remains a leading cause of maternal mortality worldwide, particularly in developing countries where it accounts for approximately 27% of maternal deaths. During a cesarean section, a blood loss exceeding 1000 mL is defined by the World Health Organization as postpartum hemorrhage, requiring immediate intervention to restore circulating volume and prevent life-threatening complications.In resource-limited environments, clinicians often rely on:Manual Syringing: Using 20 mL syringes to manually push blood into the patient, a method that is fast and inexpensive but carries a high risk of red blood cell (RBC) destruction (hemolysis) due to shear stress.Pneumatic Pressure Bags: Applying 300 mmHg of external pressure to the blood bag, which may offer more controlled infusion but requires specialized equipment and may still carry hemolysis risks.Study ObjectivesThe primary objective is to compare the safety of these two methods by measuring the incidence of hemolysis through surrogate laboratory markers. Secondary objectives focus on clinical efficacy, including the speed of hemodynamic stabilization and overall patient outcomes.Methodology and InterventionParticipants are randomized in a 1:1 ratio using computer-generated sequences and sealed envelopes. All patients receive standardized vascular access consisting of two 18-gauge peripheral cannulae and one 16-gauge external jugular cannula.Group 1 (Manual Syringing): Blood is administered using 20 mL syringes.Group 2 (Pressure Bag): Blood is administered via pneumatic pressure bags set at a constant 300 mmHg.Due to the nature of the interventions, the clinical team and patients cannot be blinded. However, the study employs triple-blinding for the outcome assessors (laboratory personnel and data collectors) and the statistical analysts to minimize bias.Outcomes and Safety MonitoringThe study measures primary safety outcomes using Lactate Dehydrogenase (LDH) and indirect bilirubin levels taken at baseline and six hours post-transfusion. Hemodynamic stability is strictly defined as maintaining a systolic blood pressure $\ge90$ mmHg, a heart rate $\le100$ bpm, and oxygen saturation $\ge95\%$ for at least 30 minutes.To ensure participant safety, the protocol includes a mitigation strategy: if significant hemolysis is suspected, the transfusion will be halted immediately, and the patient will receive supportive care, including hydration and electrolyte monitoring.Sample Size and AnalysisThe study aims to enroll 50 participants (25 per group), which includes an over-sampling buffer from the calculated requirement of 44 total participants to maintain a 95% confidence level and 90% power. Data analysis will utilize independent t-tests or Mann-Whitney U tests for continuous variables and Chi-square or Fisher's exact tests for categorical outcomes
- Conditions
- Obstetric Hemostasis, Intravascular Hemolysis, Major Obstetric Hemorrhage, Manual Syringing Transfusion, Pneumatic Pressure Bag Transfusion
- Being tested
- Manual syringing, pneumatic pressure bag
- Keywords
- Major Obstetric Hemorrhage,, Manual Syringing Transfusion, Pneumatic Pressure Bag Transfusion, Intravascular Hemolysis
- Medical subject headings
- Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual syringingDevice
Participants in this arm receive blood products administered manually by clinical staff using 20 mL syringes through 18-gauge peripheral and 16-gauge external jugular cannulae
pneumatic pressure bagDevice
Participants in this arm receive blood products administered using a pneumatic pressure bag inflated to a constant 300 mmHg through 18-gauge peripheral and 16-gauge external jugular cannulae
| Study group | Role | What they receive |
|---|---|---|
| Manual Syringing with 20 mL Syringes. | Experimental | Participants in this arm receive blood products administered manually by clinical staff using 20 mL syringes through 18-gauge peripheral and 16-gauge external jugular cannulae Receives: Device: Manual syringing |
| Blood transfusion via pneumatic pressure bags set at 300 mmHg | Experimental | Participants in this arm receive blood products administered using a pneumatic pressure bag inflated to a constant 300 mmHg through 18-gauge peripheral and 16-gauge external jugular cannulae Receives: Device: pneumatic pressure bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemolysis incidence evaluated using surrogate markers
The primary outcome of this study is Hemolysis incidence evaluated using surrogate markers:
- Lactate Dehydrogenase (LDH) levels,
Measured: From enrollment to the end of treatment at 6 hours post transfusion
Hemolysis incidence evaluated using surrogate markers: Indirect bilirubin levels
The primary outcome of this study is Hemolysis incidence evaluated using surrogate markers:
- Indirect bilirubin levels
Measured: From enrollment until 6 hours post operative
Secondary outcomes (3)
Achievement of hemodynamic stability
Achievement of hemodynamic stability in patients undergoing cesarean section complicated by major obstetric hemorrhage, comparing manual syringe transfusion versus pneumatic pressure bag transfusion. Hemodynamic stability is defined as the sustained achievement of the following for at least 30 minutes: Systolic blood pressure (BP) ≥90 mmHg, Heart rate ≤100 beats per minute (bpm), Oxygen saturation ≥95%.
Measured: From enrollment to the end of treatment at 6 hours post transfusion
Total volume of blood products administered
Total volume of blood products administered
Measured: From enrollment to the end of treatment at 6 hours post transfusion
Transfusion-related complications
Transfusion-related complications such as:
- Acute kidney injury,
- Transfusion reactions
Measured: From enrollment to the end of treatment at 6 hours post transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Sep 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obstetric HemostasisStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soudy Salah Hammad, Aswan University
- Investigators
- Mohammed Saeed, lecturer, Study chair, Aswan University-Faculty of Medicine-New Aswan City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466719
- Sponsor's protocol ID
- 1127/7/25
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared for the following reasons: Privacy and Confidentiality: The study involves sensitive maternal health data, and the current protocol is designed to restrict data access strictly to the primary research team to ensure participant anonymity. Institutional Policy: In accordance with the standards of Aswan University Hospital, data is stored in secure, password-protected databases with access limited to authorized investigators only. Ethical Constraints: The informed consent signed by participants specifies that their data will be used solely for the purposes of this specific research study and will not be made available for secondary use by outside researchers
Publications
Grossberg AJ, Fowl DA, Merritt BT, Nackley GM, Polit-Moran JA, Savona CL, Galwankar SC. Comparing the Push-Pull Technique to Pressure Bag for Administration of Blood Products: A Prospective Nonblinded Observation Simulation-based Study (CoPP toP Study). J Emerg Trauma Shock. 2024 Oct-Dec;17(4):208-211. doi: 10.4103/jets.jets_14_24. Epub 2024 Nov 5.
PubMed 39911470Abdul-Kadir R, McLintock C, Ducloy AS, El-Refaey H, England A, Federici AB, Grotegut CA, Halimeh S, Herman JH, Hofer S, James AH, Kouides PA, Paidas MJ, Peyvandi F, Winikoff R. Evaluation and management of postpartum hemorrhage: consensus from an international expert panel. Transfusion. 2014 Jul;54(7):1756-68. doi: 10.1111/trf.12550. Epub 2014 Mar 12.
PubMed 24617726Orsi KCSC, Kita VY, de Souza AHP, Tsunemi MH, Avelar AFM. Neonatal Transfusion Practice: Hemolysis Markers After In Vitro Infusion of Packed Red Blood Cells by the Gravitational Method or Syringe Pump in a Peripheral Catheter. J Perinat Neonatal Nurs. 2021 Oct-Dec 01;35(4):E40-E49. doi: 10.1097/JPN.0000000000000571.
PubMed 34726655Choi YJ, Huh H, Bae GE, Ko EJ, Choi SU, Park SH, Lim CH, Shin HW, Lee HW, Yoon SZ. Effect of varying external pneumatic pressure on hemolysis and red blood cell elongation index in fresh and aged blood: Randomized laboratory research. Medicine (Baltimore). 2018 Jul;97(28):e11460. doi: 10.1097/MD.0000000000011460.
PubMed 29995802De Villiers WL, Murray AA, Levin AI. Expediting red blood cell transfusions by syringing causes significant hemolysis. Transfusion. 2017 Nov;57(11):2747-2751. doi: 10.1111/trf.14283. Epub 2017 Aug 20.
PubMed 28833178
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety of Manual Syringing Versus Pneumatic Pressure Bag for Blood Transfusion in Patients Undergoing Cesarean Section With Major Obstetric Hemorrhage
- ClinicalTrials.gov ID
- NCT07466719
- Acronym / sponsor ID
- 1127/7/25
- Conditions
- Obstetric Hemostasis, Intravascular Hemolysis, Major Obstetric Hemorrhage, Manual Syringing Transfusion, Pneumatic Pressure Bag Transfusion
- Keywords
- Major Obstetric Hemorrhage,, Manual Syringing Transfusion, Pneumatic Pressure Bag Transfusion, Intravascular Hemolysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 12 Mar 2026 (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.
The goal of this clinical trial is to compare the safety and efficacy of manual syringing versus pneumatic pressure bags for blood transfusion in patients experiencing major obstetric hemorrhage during a cesarean section. It will also evaluate the effectiveness of these methods in rapidly stabilizing patient vital signs. The main questions it aims to answer are:Does manual syringing result in a higher incidence of hemolysis (red blood cell destruction) compared to pneumatic pressure bags?Which method is more effective and faster at achieving hemodynamic stability (restoring normal blood pressure, heart rate, and oxygen levels)?Are there differences between the two methods regarding total blood product usage, transfusion-related complications, and the length of hospital stay?Researchers will compare manual syringing (using 20 mL syringes) to pneumatic pressure bags (inflated to 300 mmHg) to determine which is safer and more efficient for emergency transfusions in resource-constrained environments.Participants will:Be women aged 18-45 years undergoing a cesarean section who are diagnosed with major obstetric hemorrhage (blood loss >1000 mL or hemodynamic instability).Be randomly assigned to one of two groups to receive their blood transfusion through either the manual syringe method or a pneumatic pressure bag.Receive standard vascular access through multiple peripheral and jugular cannulae.Undergo close monitoring of vital signs to determine the time to stabilization.Provide blood samples at baseline and six hours post-transfusion to measure markers of hemolysis, specifically Lactate Dehydrogenase (LDH) and indirect bilirubin levels.Be monitored for any transfusion-related complications, such as allergic reactions or acute kidney injury, during their hospital stay and for major complications up to 30 days postoperatively
Detailed description
This prospective, single-center, randomized controlled clinical trial (Phase III) is designed to evaluate and compare two common methods for rapid blood transfusion-manual syringing and pneumatic pressure bags-in the specific context of major obstetric hemorrhage (MOH) during cesarean sections. The study is conducted at Aswan University Hospital in Egypt, where both techniques are currently employed in emergency settings, yet a systematic evaluation of their relative safety and clinical efficacy is lacking.Background and RationaleMajor obstetric hemorrhage remains a leading cause of maternal mortality worldwide, particularly in developing countries where it accounts for approximately 27% of maternal deaths. During a cesarean section, a blood loss exceeding 1000 mL is defined by the World Health Organization as postpartum hemorrhage, requiring immediate intervention to restore circulating volume and prevent life-threatening complications.In resource-limited environments, clinicians often rely on:Manual Syringing: Using 20 mL syringes to manually push blood into the patient, a method that is fast and inexpensive but carries a high risk of red blood cell (RBC) destruction (hemolysis) due to shear stress.Pneumatic Pressure Bags: Applying 300 mmHg of external pressure to the blood bag, which may offer more controlled infusion but requires specialized equipment and may still carry hemolysis risks.Study ObjectivesThe primary objective is to compare the safety of these two methods by measuring the incidence of hemolysis through surrogate laboratory markers. Secondary objectives focus on clinical efficacy, including the speed of hemodynamic stabilization and overall patient outcomes.Methodology and InterventionParticipants are randomized in a 1:1 ratio using computer-generated sequences and sealed envelopes. All patients receive standardized vascular access consisting of two 18-gauge peripheral cannulae and one 16-gauge external jugular cannula.Group 1 (Manual Syringing): Blood is administered using 20 mL syringes.Group 2 (Pressure Bag): Blood is administered via pneumatic pressure bags set at a constant 300 mmHg.Due to the nature of the interventions, the clinical team and patients cannot be blinded. However, the study employs triple-blinding for the outcome assessors (laboratory personnel and data collectors) and the statistical analysts to minimize bias.Outcomes and Safety MonitoringThe study measures primary safety outcomes using Lactate Dehydrogenase (LDH) and indirect bilirubin levels taken at baseline and six hours post-transfusion. Hemodynamic stability is strictly defined as maintaining a systolic blood pressure $\ge90$ mmHg, a heart rate $\le100$ bpm, and oxygen saturation $\ge95\%$ for at least 30 minutes.To ensure participant safety, the protocol includes a mitigation strategy: if significant hemolysis is suspected, the transfusion will be halted immediately, and the patient will receive supportive care, including hydration and electrolyte monitoring.Sample Size and AnalysisThe study aims to enroll 50 participants (25 per group), which includes an over-sampling buffer from the calculated requirement of 44 total participants to maintain a 95% confidence level and 90% power. Data analysis will utilize independent t-tests or Mann-Whitney U tests for continuous variables and Chi-square or Fisher's exact tests for categorical outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Syringing with 20 mL Syringes. | Experimental | Device: Manual syringingParticipants in this arm receive blood products administered manually by clinical staff using 20 mL syringes through 18-gauge peripheral and 16-gauge external jugular cannulae |
| Blood transfusion via pneumatic pressure bags set at 300 mmHg | Experimental | Device: pneumatic pressure bagParticipants in this arm receive blood products administered using a pneumatic pressure bag inflated to a constant 300 mmHg through 18-gauge peripheral and 16-gauge external jugular cannulae |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 18-45 years undergoing cesarean section
- Diagnosed major obstetric hemorrhage (blood loss ≥1000 mL or hemodynamic instability requiring transfusion)
- Written informed consent for participation
Key exclusion criteria (4 listed)
- Pre-existing hemolytic conditions (e.g., sickle cell disease, thalassemia)
- Known hypersensitivity to blood products
- Severe baseline coagulopathy (defined as INR > 2.0 or Platelet count < 50,000/mm³) or established disseminated intravascular coagulation (DIC) prior to randomization
- Refusal to receive blood transfusion
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 |
|---|---|---|
| Manual syringingParticipants in this arm receive blood products administered manually by clinical staff using 20 mL syringes through 18-gauge peripheral and 16-gauge external jugular cannulae | Device | Manual Syringing with 20 mL Syringes. |
| pneumatic pressure bagParticipants in this arm receive blood products administered using a pneumatic pressure bag inflated to a constant 300 mmHg through 18-gauge peripheral and 16-gauge external jugular cannulae | Device | Blood transfusion via pneumatic pressure bags set at 300 mmHg |
Primary outcome
Hemolysis incidence evaluated using surrogate markers
Time frame: From enrollment to the end of treatment at 6 hours post transfusion
The primary outcome of this study is Hemolysis incidence evaluated using surrogate markers: 1. Lactate Dehydrogenase (LDH) levels,
Hemolysis incidence evaluated using surrogate markers: Indirect bilirubin levels
Time frame: From enrollment until 6 hours post operative
The primary outcome of this study is Hemolysis incidence evaluated using surrogate markers: 2. Indirect bilirubin levels
3 secondary outcomes
Achievement of hemodynamic stability
Time frame: From enrollment to the end of treatment at 6 hours post transfusion
Total volume of blood products administered
Time frame: From enrollment to the end of treatment at 6 hours post transfusion
Transfusion-related complications
Time frame: From enrollment to the end of treatment at 6 hours post transfusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Background: PubMed 39911470Grossberg AJ, Fowl DA, Merritt BT, Nackley GM, Polit-Moran JA, Savona CL, Galwankar SC. Comparing the Push-Pull Technique to Pressure Bag for Administration of Blood Products: A Prospective Nonblinded Observation Simulation-based Study (CoPP toP Study). J Emerg Trauma Shock. 2024 Oct-Dec;17(4):208-211. doi: 10.4103/jets.jets_14_24. Epub 2024 Nov 5.
- Background: PubMed 24617726Abdul-Kadir R, McLintock C, Ducloy AS, El-Refaey H, England A, Federici AB, Grotegut CA, Halimeh S, Herman JH, Hofer S, James AH, Kouides PA, Paidas MJ, Peyvandi F, Winikoff R. Evaluation and management of postpartum hemorrhage: consensus from an international expert panel. Transfusion. 2014 Jul;54(7):1756-68. doi: 10.1111/trf.12550. Epub 2014 Mar 12.
- Background: PubMed 34726655Orsi KCSC, Kita VY, de Souza AHP, Tsunemi MH, Avelar AFM. Neonatal Transfusion Practice: Hemolysis Markers After In Vitro Infusion of Packed Red Blood Cells by the Gravitational Method or Syringe Pump in a Peripheral Catheter. J Perinat Neonatal Nurs. 2021 Oct-Dec 01;35(4):E40-E49. doi: 10.1097/JPN.0000000000000571.
- Background: PubMed 29995802Choi YJ, Huh H, Bae GE, Ko EJ, Choi SU, Park SH, Lim CH, Shin HW, Lee HW, Yoon SZ. Effect of varying external pneumatic pressure on hemolysis and red blood cell elongation index in fresh and aged blood: Randomized laboratory research. Medicine (Baltimore). 2018 Jul;97(28):e11460. doi: 10.1097/MD.0000000000011460.
- Background: PubMed 28833178De Villiers WL, Murray AA, Levin AI. Expediting red blood cell transfusions by syringing causes significant hemolysis. Transfusion. 2017 Nov;57(11):2747-2751. doi: 10.1111/trf.14283. Epub 2017 Aug 20.
- Individual participant dataSharing planned: No. Individual participant data will not be shared for the following reasons: Privacy and Confidentiality: The study involves sensitive maternal health data, and the current protocol is designed to restrict data access strictly to the primary research team to ensure participant anonymity. Institutional Policy: In accordance with the standards of Aswan University Hospital, data is stored in secure, password-protected databases with access limited to authorized investigators only. Ethical Constraints: The informed consent signed by participants specifies that their data will be used solely for the purposes of this specific research study and will not be made available for secondary use by outside researchers
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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.
Soudy Hammad, lecturer of anesthesia,SICU, contact
Mohammed Saeed, lecturer study chair
Aswan University-Faculty of Medicine-New Aswan City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual syringing and pneumatic pressure bag in people with Obstetric Hemostasis and Intravascular Hemolysis, run by Aswan University at 1 site in Egypt.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 12 Mar 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soudy Hammad, lecturer of anesthesia,SICU, (+201014761523 ext. +201017446683, soudi.salah@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemolysis incidence evaluated using surrogate markers (time frame: From enrollment to the end of treatment at 6 hours post transfusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07466719, which also lists 5 linked publications.
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 12 Mar 2026.