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Completed

NCT Number: NCT06824753

Postoperative Use Of Pump Blood İn Cardiopulmonary Bypass Surgery

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University

Erzurum, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective cardiopulmonary bypass surgery
  • Ages 18-70

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

Treatment and study plan

oxygenator and tubing set blood transfusion

Other

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

Primary outcomes

  1. 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

  1. Incidence of TRALI, TACO, AKI, re-operation, and total drainage amount measured using standard clinical and laboratory criteria

    Time frame: Until the end of the 7th postoperative day

    TRALI: Diagnosed according to the 2019 International Society of Blood Transfusion criteria.

    TACO: Assessed by clinical signs, chest X-ray, and hemodynamic parameters.

    AKI: Evaluated using KDIGO criteria based on serum creatinine and urine output.

    Re-operation: Number of patients requiring surgical re-intervention.

    Drainage amounts: Measured in milliliters from postoperative drains.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

Effect Of Postoperative Pump Blood Administration On Erythrocyte Suspension Requirement And Coagulation Parameters İn Cardiopulmonary Bypass Surgery

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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