Postoperative Use Of Pump Blood İn Cardiopulmonary Bypass Surgery

Not Applicable

Completed

• Conditions: Cardio-pulmonary Bypass

• Registration Number: NCT06824753
• Lead Sponsor: Ataturk University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Primary Completion: 2024-04-01
• Study Completion: 2024-06-01
• Study First Submitted: 2024-10-11
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-08
• Last Update Submitted: 2025-02-08
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of the need for erythrocyte suspension in the postoperative period	Until the end of the 7th postoperative day	The primary aim of our study was to investigate the effect of postoperative pump blood administration on the need for red blood cell suspension.

Secondary Outcome Measures

Name	Time	Method
Comparison of the TRALI (transfusion-related lung injury), TACO (transfusion-related cardiac overload), AKI (acute kidney injury), re-operation and drainage amounts	Until the end of the 7th postoperative day	The secondary aims of the study were to comparison of the TRALI (transfusion-related lung injury), TACO (transfusion-related cardiac overload), AKI (acute kidney injury), re-operation and drainage amounts

Trial Locations

Locations (1)

Ataturk University; 🇹🇷 Erzurum, Turkey