Blood Transfusion Reaction

Researchers are evaluating the safety and feasibility of lung transplants from blood group A2 donors to blood group O recipients. This study aims to increase the donor pool for blood group O lung transplant candidates, who often face longer wait times and higher mortality on the waitlist. It is the first prospective study worldwide to assess ABO-incompatible lung transplants in this way. The intervention involves lung transplant surgery using lungs from blood group A2 donors transplanted into blood group O recipients who have low anti-A antibody levels and a negative virtual crossmatch at the time of transplant. The study monitors the recipients closely after surgery to assess immune response and transplant success. Participants will be monitored through various evaluations including antibody levels on post-operative days 5 or 12, primary graft dysfunction grading in the first three days, and assessment for rejection or infection over the following years. Long-term follow-up up to 10 years will evaluate graft function, chronic lung problems, infections, malignancies, and survival outcomes. The total participation time varies depending on individual follow-up and outcomes.

Researchers are investigating the use of ABM/P-15 bone graft compared to traditional bone graft in patients undergoing surgery for Adult Spinal Deformity (ASD). This study aims to improve clinical outcomes by promoting faster bone healing, reducing the need for additional surgeries, minimizing complications, and improving health-related quality of life. The trial is a prospective, randomized, controlled clinical study conducted at a specialized spine unit. Participants are randomly assigned to receive either the ABM/P-15 bone graft, which is a device combining anorganic bovine bone mineral with a synthetic peptide to enhance bone growth, or a standard bone graft made from locally harvested bone mixed with morselized allogenic femoral head. Both graft types are used during posterior spinal instrumentation and fusion surgery, with anterior support added as needed. The ABM/P-15 bone graft is placed on the spine structures and contained by the surrounding muscle. The study includes preoperative planning, surgery, and follow-up evaluations up to two years. Participants complete questionnaires before surgery and at 3 months, 1 year, and 2 years after surgery. They undergo X-rays at multiple time points and a CT scan one year after surgery to assess bone fusion and detect pseudarthrosis. Researchers track revision surgeries, adverse events, and cost-effectiveness during the study. Data on surgical details, complications, medication use, and rehabilitation are collected from medical records. The total participation lasts about two years, allowing for detailed assessment of outcomes and safety.

This research aims to find out if giving plasma from a donor who recently had Chikungunya infection to newborns whose mothers have peripartum Chikungunya infection can improve the chances of newborns surviving without brain inflammation or damage within the first five days of life. The study will compare these results with a group of newborns who did not receive plasma transfusion due to delays in diagnosis or transfer, or parental refusal. The trial is led by the Centre Hospitalier Universitaire de la Réunion and includes newborns up to 2 days old. Participants in the treatment group will receive a plasma transfusion from donors who declared Chikungunya infection less than six months ago. This treatment is given to newborns whose mothers were diagnosed with Chikungunya infection around the time of birth. Newborns will be treated within 12 hours of birth or diagnosis depending on timing. There is also a parallel observational group of newborns who will not receive plasma but will be monitored as part of standard care. During the study, newborns will have daily medical and biological tests from day 1 to day 7, and a follow-up visit between 1 and 3 months of age. For the observational group, data collected during routine care up to 3 months will be used for research. Researchers will measure the effectiveness of early plasma administration in preventing neonatal brain inflammation or damage within five days after treatment. Safety and health will be monitored throughout the trial period, which is planned to end in late 2027.

Researchers are comparing two methods of recovering blood from surgical sponges used during heart and lung surgeries. The study evaluates manual wringing by hand versus automated wringing using an FDA-approved suction device called ProCell. Both methods are currently used at University Hospitals based on the surgeon's choice. Participants undergo surgeries such as heart or lung transplants, redo sternotomies, aortic surgeries, or multi-valve repairs/replacements. During surgery, blood is recovered from sponges either by hand wringing or using the ProCell device. The study measures blood components and recovery efficiency at baseline and after processing up to 120 minutes. Participants are monitored during surgery and blood samples are analyzed for plasma free hemoglobin, fragmented red blood cells, lactate dehydrogenase, and haptoglobin levels. The volume and weight of blood recovered and the time taken to wring sponges are recorded. The study is conducted at University Hospitals and lasts through the surgical procedure and immediate post-processing period.

Researchers are studying patients undergoing transcatheter aortic valve implantation (TAVI), an emerging procedure used in high-risk cardiac surgery and cardiology patients who are often considered inoperable by conventional means. This observational study aims to understand the specific anesthesiologic challenges faced by cardiac anesthesiologists during these procedures. The study is sponsored by Deutsches Herzzentrum Muenchen and focuses on improving perioperative care in this high-risk group. This study involves monitoring patients who receive TAVI, without any experimental treatments or interventions. The study observes the anesthesia process and perioperative care during the procedure. There are no comparison groups or drug treatments involved. Participants will be observed during the perioperative period, specifically for one day around the time of the procedure. Researchers will collect data on anesthesiology care and related cardiac events during the operation. Additionally, participants may be followed for up to 10 years to assess longer-term outcomes. The study does not involve any additional treatments and focuses on collecting observational data to better understand anesthesia management in TAVI.

This research evaluates the use of oral anticoagulation (OAC) combined with background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. The study aims to assess how effectively this approach prevents thromboembolic events and its safety regarding major bleeding. Patients who decline randomization may join a parallel registry to capture their treatment choices and risk profiles. Participants will be randomly assigned to one of two treatment groups: an experimental arm receiving OAC (either a vitamin K antagonist or a direct oral anticoagulant) along with antiplatelet therapy, or a control arm receiving antiplatelet therapy alone. The anticoagulation treatment lasts 90 days, and patients in the control group who experience recurrent atrial fibrillation after 30 days may switch to OAC. Follow-up includes clinic visits at 90 days and phone calls at 30, 60, and 180 days. A digital health substudy involving a wearable heart monitor for 30 days post-discharge is also offered to some participants. During the study, researchers will monitor outcomes such as death, stroke, transient ischemic attack, myocardial infarction, and thromboembolism up to 180 days after randomization, along with bleeding events at 90 days. Data collection includes medical record reviews, risk profiling, and use of anticoagulants and antiplatelets. Safety and effectiveness will be analyzed by comparing the two treatment strategies. Participation may last up to six months, with assessments conducted in person and by phone.

Researchers are studying children with acyanotic congenital heart disease undergoing elective repair of a congenital heart defect to evaluate the use of an antihistamine for preventing hypotensive transfusion reactions after blood-primed cardiopulmonary bypass (CPB). This randomized, double-blinded, placebo-controlled Phase 4 study aims to compare the effects of combined chlorpheniramine versus a placebo in this pediatric population. Participants will be randomly assigned to one of two groups: one group will receive a single intravenous dose of chlorpheniramine at 0.25 mg/kg in 2 ml, and the other group will receive an equal volume of normal saline as a placebo. This dose is administered immediately after separation from CPB and before protamine administration. The study includes 40 children aged 1 to 7 years. During the study, researchers will monitor for episodes of hypotension within 15 minutes after weaning from cardiopulmonary bypass. Children will be closely observed during the procedure, and their response to the treatment will be assessed. The study will continue until December 2026, with safety and outcome measures collected during and after the procedure to evaluate the incidence of hypotensive transfusion reactions.

Heart failure is a global health issue, and left ventricular assist devices (LVADs) like the HeartMate 3 are increasingly used to improve survival for patients with advanced heart failure. Despite advances, complications related to blood compatibility, such as clotting and bleeding, remain serious concerns. This trial investigates the safety and effectiveness of using an antithrombotic regimen without aspirin in patients supported by the HeartMate 3 LVAD, building on previous findings that avoiding aspirin may reduce bleeding without increasing clotting risks. The study is a prospective, randomized, controlled trial comparing two treatment groups of advanced heart failure patients who have been supported by the HeartMate 3 LVAD for more than three months. One group will receive warfarin alone, with doses adjusted to maintain a specific blood clotting goal, while the other group will receive warfarin combined with aspirin, which is the current standard of care. Participants will be randomly assigned to one of these two antithrombotic regimens and followed over time to assess outcomes. Participants will be monitored for one year after randomization, with researchers tracking survival free from major hemocompatibility-related events like stroke, pump thrombosis, and significant bleeding. Secondary outcomes such as rates of bleeding, clotting, stroke, rehospitalization, and economic impact will also be evaluated. The study aims to enroll up to 128 patients to ensure sufficient power and includes regular follow-ups to assess safety, treatment adherence, and clinical events.

Researchers are evaluating the use of a direct oral anticoagulant (DOAC) called apixaban compared to no anticoagulant in patients undergoing abdominal or pelvic surgery. This international, multicenter, randomized controlled trial focuses on patients with a moderate risk of venous thromboembolism (VTE) and bleeding where the benefits and harms of thromboprophylaxis are unclear. The study aims to clarify whether apixaban provides a net benefit or if avoiding anticoagulation is preferable in this population. The trial enrolls 5,436 patients who will be randomly assigned to receive either apixaban 2.5 mg orally twice daily for 28 days alongside standard mechanical prevention or no anticoagulant with standard mechanical prevention alone. Mechanical prophylaxis is provided as standard care in both groups. The study is open-label and compares the outcomes of using apixaban versus no anticoagulation after surgery. Participants will be monitored for 90 days to assess the incidence of VTE, including deep vein thrombosis and pulmonary embolism. Researchers will collect data on symptomatic events and major bleeding. Follow-up visits and assessments will track safety and effectiveness outcomes. The study’s results will help guide decisions about thromboprophylaxis after abdominal and pelvic surgeries in patients at moderate risk.

Researchers are evaluating the use of prophylactic preoperative tranexamic acid (TXA) and desmopressin in patients with advanced kidney disease undergoing noncardiac surgery. This pilot study aims to assess the feasibility and design of a larger trial, provide preliminary safety and efficacy data, and gather pharmacokinetic information to help select appropriate dosages. The study addresses a gap since patients with severe kidney disease have been excluded from large trials despite bleeding risks during surgery. Participants will be randomly assigned to receive intravenous TXA, desmopressin, both, or placebos shortly before surgery. TXA dosing varies based on kidney function and dialysis status, with either 1000 mg or 500 mg infused over 10 minutes. Desmopressin is given as a 20 mcg infusion over 30 minutes. Placebo infusions use saline solutions matching the timing and volume of the active drugs. Treatment is administered within 20 minutes before the skin incision. During the study, researchers will monitor recruitment rates, drug administration timing, and conduct a 30-day follow-up after surgery. They will assess bleeding outcomes, blood transfusions, surgical complications, cardiovascular events, kidney function changes, and other safety measures. The total observation period includes the day of surgery and 30 days afterward, tracking hospital stay duration and postoperative recovery indicators to evaluate the interventions' impact comprehensively.