PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Fresh Frozen Plasma; Prothrombin Complex Concentrates; Blood Loss, Surgical; Cardiovascular Surgical Procedures; Bleeding

Treatments: Drug: Prothrombin complex concentrate (Human); Biological: Fresh frozen plasma (FFP)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02557672

14-009579

Details and patient eligibility

About

This will be the first prospective randomized controlled clinical trial directly comparing Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for post cardiopulmonary bypass microvascular bleeding and factor-mediated coagulopathy. Is there a difference in bleeding and transfusion requirements in patients received PCC versus FFP?

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

All subjects accepted for this study must:

• Be 18 years of age
• Be undergoing elective cardiac surgical procedure utilizing cardiopulmonary bypass
• Have evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team in addition to a PT >16.6 sec or INR >1.6 sec.

Exclusion Criteria

Subjects who have one or more of the following will be excluded from the study:

• Are unable to grant informed consent or comply with study procedure
• History of hypercoagulable condition (e.g. Factor V Leiden, AT-3 deficiency, Prothrombin gene mutation, Anti-phospholipid antibody syndrome, etc) or previous unprovoked thromboembolic complications
• Coagulopathic conditions such as factor deficiencies, factor inhibitors, heparin induced thrombocytopenia, or use of intravenous anticoagulants other than heparin at the time of cardiovascular surgery
• Thromboembolic event within past 3 months
• Received oral therapy with clopidogrel, prasugrel, rivaroxaban or dabigatran within the past 5 days
• Patients taking chronic warfarin therapy who have not discontinued treatment and demonstrated an INR <1.3 prior to surgery
• Fibrinogen level <150 mg/dL on initial post cardiopulmonary bypass labs
• Antithrombin 3 level < 80% control (preoperative)
• Are undergoing emergency open heart-surgery
• Cardiopulmonary bypass time is expected to be < 30 minutes
• Age < 18 years of age
• Are pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Fresh frozen plasma

Active Comparator group

Description:

After cardiopulmonary bypass, patients will receive protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, will be collected via preexisting arterial access. If ACT \>10% baseline additional protamine will be given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field will occur 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec will receive fresh frozen plasma as this is standard therapy per our institutional algorithm at a dose of 10-15 mL/kg rounded up to the nearest unit.

Treatment:

Biological: Fresh frozen plasma (FFP)

Prothrombin complex concentrate

Experimental group

Description:

After cardiopulmonary bypass, patients will receive protamine at dose 0.01 mg/unit of heparin given with target ACT within 10% of baseline value. After protamine administration the ACT, CBC, PT/ INR, APTT, and fibrinogen, will be collected via preexisting arterial access. If ACT \>10% baseline additional protamine will be given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field will occur 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec will receive Prothrombin complex concentrate (Human) 15 units/kg.

Treatment:

Drug: Prothrombin complex concentrate (Human)