NCT07466719

Comparison of Efficacy and Safety of Manual Syringing Versus Pneumatic Pressure Bag for Blood Transfusion in Patients Undergoing Cesarean Section With Major Obstetric Hemorrhage

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Aswan University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
DEVICE	Manual syringing	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
DEVICE	pneumatic pressure bag	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

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2026-03-12
• Last updated: 2026-03-12

Locations

1 site across 1 country: Egypt