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

Обзор

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

Подробное описание

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

Вмешательства

• Устройство 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
• Устройство 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

Первичные конечные точки

• Hemolysis incidence evaluated using surrogate markers [Срок оценки: From enrollment to the end of treatment at 6 hours post transfusion]
• Hemolysis incidence evaluated using surrogate markers: Indirect bilirubin levels [Срок оценки: From enrollment until 6 hours post operative]

Вторичные конечные точки (3)

• Achievement of hemodynamic stability [Срок оценки: From enrollment to the end of treatment at 6 hours post transfusion]
• Total volume of blood products administered [Срок оценки: From enrollment to the end of treatment at 6 hours post transfusion]
• Transfusion-related complications [Срок оценки: From enrollment to the end of treatment at 6 hours post transfusion]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Aswan University Hospital — Aswān

Публикации

• 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. PMID 39911470
• Abdul-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. PMID 24617726
• Orsi 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. PMID 34726655
• Choi 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. PMID 29995802
• De 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. PMID 28833178

Идентификаторы

NCT: NCT07466719 · 1127/7/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗