Clinical trial NCT06824753: Postoperative Use Of Pump Blood İn Cardiopulmonary Bypass Surgery
Official title: Effect Of Postoperative Pump Blood Administration On Erythrocyte Suspension Requirement And Coagulation Parameters İn Cardiopulmonary Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardio-pulmonary Bypass
Keywords: Autologous blood transfusion
ROTEM
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Elective cardiopulmonary bypass surgery
2. Ages 18-70

Exclusion Criteria:

1. Patients not accepting to be included in the study
2. Having kidney disease
3. Having hematological disease
4. Having peripheral artery disease

3- Ejection Fraction \< 45% 4- Anticoagulants usage

Primary outcomes:
measure: Comparison of the need for erythrocyte suspension in the postoperative period
timeFrame: Until the end of the 7th postoperative day
Secondary outcomes:
measure: Comparison of the TRALI (transfusion-related lung injury), TACO (transfusion-related cardiac overload), AKI (acute kidney injury), re-operation and drainage amounts
timeFrame: Until the end of the 7th postoperative day
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
citation: Bennett-Guerrero E, Zhao Y, O'Brien SM, Ferguson TB Jr, Peterson ED, Gammie JS, Song HK. Variation in use of blood transfusion in coronary artery bypass graft surgery. JAMA. 2010 Oct 13;304(14):1568-75. doi: 10.1001/jama.2010.1406.
citation: Paone G, Likosky DS, Brewer R, Theurer PF, Bell GF, Cogan CM, Prager RL; Membership of the Michigan Society of Thoracic and Cardiovascular Surgeons. Transfusion of 1 and 2 units of red blood cells is associated with increased morbidity and mortality. Ann Thorac Surg. 2014 Jan;97(1):87-93; discussion 93-4. doi: 10.1016/j.athoracsur.2013.07.020. Epub 2013 Oct 3.