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The effect of adding fresh frozen plasma to the prime solution of the cardiopulmonary bypass pump on coagulation tests and patient return to the operating room

The effect of adding fresh frozen plasma to the prime solution of the cardiopulmonary bypass pump on coagulation tests and patient return to the operating room in patients undergoing coronary artery bypass graft surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251006067524N1
Enrollment
76
Registered
2025-11-10
Start date
2025-10-23
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Bypass Grafting. Atherosclerotic heart disease of native coronary artery without angina pectoris

Interventions

Intervention 1: Intervention group: Addition of plasma to the cardiopulmonary bypass pump prime during surgery, with the volume determined by the surgeon based on the prime volume (5 cc per kilogram)

Sponsors

Shahid Rajaei Cardiovascular Research, Education, and Treatment Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patient's willingness to participate in the study Informed consent to participate in the study Age between 18 and 75 years Left ventricular ejection fraction greater than 30% No history of sternotomy or previous cardiac surgeries No history of liver, kidney, or pulmonary diseases No pacemaker implantation Not pregnant No history of allergy to fresh frozen plasma (FFP) No history of glucose-6-phosphate dehydrogenase (G6PD)

Exclusion criteria

Exclusion criteria: Pump time exceeding 120 minutes Cross-clamp time exceeding 100 minutes Use of ultrafiltration technique Reconnection of the patient to the cardiopulmonary bypass machine for any reason during surgery Presence of specific hematologic disorders

Design outcomes

Primary

MeasureTime frame
Laboratory parameters including hemoglobin, hematocrit, PT, PTT, and INR. Timepoint: After admission to the ICU and 24 hours after surgery. Method of measurement: Blood Test.;Patient's return to the operating room. Timepoint: Documentation of patient’s return to the operating room within 24 hours after surgery. Method of measurement: Check list.

Secondary

MeasureTime frame
Amount of received blood products. Timepoint: After admission to the ICU and 24 hours after surgery. Method of measurement: Checklist for documenting the amount of received blood products.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarshad Jalili Shahandashti

Shahid Rajaei Cardiovascular Research, Education, and Treatment Institute

jalilishfarshad@gmail.com+98 21 23921

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026