Comparison of Efficacy and Safety of Manual Syringing Versus Pneumatic Pressure Bag for Blood Tra… (NCT07466719) | Clinical Trial Compass
RecruitingNot Applicable
Comparison of Efficacy and Safety of Manual Syringing Versus Pneumatic Pressure Bag for Blood Transfusion in Patients Undergoing Cesarean Section With Major Obstetric Hemorrhage
Egypt50 participantsStarted 2025-09-01
Plain-language 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. 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
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing two methods of giving blood transfusions quickly during a cesarean section — manual syringing versus a pneumatic pressure bag — and one of the main things they're measuring is whether either method damages red blood cells (hemolysis); could you explain what that means for my safety, and how often hemolysis is a concern with emergency transfusions?
2Since this trial is listed as 'Phase NA,' which often means it's comparing existing procedures rather than testing a new drug, does that change what is already known about the risks of both transfusion methods, and would I be receiving a technique that has already been used in routine obstetric care?
3The study is specifically enrolling patients undergoing cesarean section with major obstetric hemorrhage — if I were to experience that level of bleeding, how would my care team decide in the moment which transfusion method to use, and would my participation in this trial affect any other emergency decisions being made?
4One of the main measurements in this trial is indirect bilirubin levels as a sign of red blood cell breakdown — if my results showed elevated bilirubin during or after the transfusion, what follow-up care or monitoring would be in place for me and my baby?
5Outside of this trial, is there a standard-of-care approach your hospital already uses for rapid transfusion during major obstetric hemorrhage that I could receive instead, and how does the evidence behind that compare to what this study is trying to find out?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hemolysis incidence evaluated using surrogate markers
Timeframe: From enrollment to the end of treatment at 6 hours post transfusion
2
Hemolysis incidence evaluated using surrogate markers: Indirect bilirubin levels
Timeframe: From enrollment until 6 hours post operative