About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Parallel
Treatments tested in this trial
Manual syringing
DeviceParticipants 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 bag
DeviceParticipants 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
Treatment groups
Trial outcomes
Primary outcomes
Hemolysis incidence evaluated using surrogate markers
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
The primary outcome of this study is Hemolysis incidence evaluated using surrogate markers: 2\. Indirect bilirubin levels
Secondary outcomes
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%.
Total volume of blood products administered
Total volume of blood products administered
Transfusion-related complications
Transfusion-related complications such as: * Acute kidney injury, * Transfusion reactions
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