Effect Of Postoperative Pump Blood Administration On Erythrocyte Suspension Requirement And Coagulation Parameters İn Cardiopulmonary Bypass Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ataturk University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Postoperative need for red blood cell (RBC) transfusion measured by number of RBC units administered
Study Overview
Brief Summary
In our study, the impact of administering autologous blood remaining in the cardiopulmonary bypass system during coronary artery bypass surgeries will be evaluated using the ROTEM device to assess its effect on coagulation parameters. Additionally, the influence of this autologous blood on the need for erythrocyte suspension will be examined, providing insight into its potential role in reducing transfusion requirements in the postoperative period.
Material and Method: The study included 60 patients scheduled for coronary artery bypass graft surgery who met the inclusion criteria. These patients were randomly assigned into two groups: 30 in the study group and 30 in the control group. Following the surgery, all patients were transferred to the intensive care unit under continuous monitoring. In the control group, ROTEM analysis was performed during the first postoperative hour. For the study group, blood from the oxygenator and tubing set was collected into a 1000 cc Ringer lactate bag, originally used as the pump's priming solution, under sterile conditions using a roller pump. The hematocrit levels and the total volume of the collected blood were measured and recorded in milliliters. The study group patients received a 30-minute infusion of this blood at the 1st postoperative hour. ROTEM was performed on the study group after the infusion had concluded.
Postoperative monitoring was carried out at four specific time points: the 4th hour, 24th hour, 48th hour, and upon discharge from the intensive care unit. During this period, the patients' drainage volumes, hemoglobin, hematocrit, leukocyte, and platelet counts were documented. In addition, fluid balance, BUN, and creatinine levels were tracked, along with mechanical ventilator duration and associated parameters. The study concluded with postoperative follow-up, and all collected data were analyzed statistically to assess outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Elective cardiopulmonary bypass surgery
Exclusion Criteria
- •Patients not accepting to be included in the study
- •Having kidney disease
- •Having hematological disease
- •Having peripheral artery disease
- •3- Ejection Fraction < 45% 4- Anticoagulants usage
Arms & Interventions
Control Group
autologous transfusion group
Intervention: oxygenator and tubing set blood transfusion (Other)
Outcomes
Primary Outcomes
Postoperative need for red blood cell (RBC) transfusion measured by number of RBC units administered
Time Frame: Until the end of the 7th postoperative day
The primary outcome is the requirement for postoperative red blood cell transfusion. The measurement tool is the number of RBC units transfused, recorded from hospital transfusion records from the end of surgery until the 7th postoperative day.
Secondary Outcomes
- Incidence of TRALI, TACO, AKI, re-operation, and total drainage amount measured using standard clinical and laboratory criteria(Until the end of the 7th postoperative day)
Investigators
Muhammed E Aydin
Assoc Prof
Ataturk University