PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding

Phase 4

Completed

• Conditions: Prothrombin Complex Concentrates; Blood Loss, Surgical; Cardiovascular Surgical Procedures; Fresh Frozen Plasma; Bleeding
• Interventions: Biological: Fresh frozen plasma (FFP); Drug: Prothrombin complex concentrate (Human)

• Registration Number: NCT02557672
• Lead Sponsor: Mayo Clinic

Brief Summary

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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-21
• Study First Submitted QC: 2015-09-21
• Study First Posted: 2015-09-23
• Study Start: 2016-08
• Primary Completion: 2021-06
• Study Completion: 2022-01
• Status Verified: 2022-05
• Results First Submitted: 2022-05-16
• Results First Submitted QC: 2022-05-16
• Last Update Submitted: 2022-05-16
• Results First Posted: 2022-06-07
• Last Update Posted: 2022-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fresh frozen plasma	Fresh frozen plasma (FFP)	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.
Prothrombin complex concentrate	Prothrombin complex concentrate (Human)	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.

Primary Outcome Measures

Name	Time	Method
Chest Tube Output	24 hours	The amount of chest tube drainage output from after surgery through midnight of the next day. As measured in mL.
Red Blood Cell (RBC) Blood Product Transfusion	24 hours	The number of subject's who received 0,1,2,3 or more units of RBC's transfused from completion of study drug administration though midnight of the next day.
Platelets Blood Product Transfusion	24 hours	The number of subject's who received 0,1,2,3 or more units of Platelets transfused from completion of study drug administration though midnight of the next day.
Cryoprecipitate (Cryo) Blood Product Transfusion	24 hours	The number of subject's who received 0,1,2,3 or more units of Cryo's transfused from completion of study drug administration though midnight of the next day.
Fresh Frozen Plasma (FFP) Blood Product Transfusion	24 hours	The number of subject's who received 0,1,2,3 or more units of FFP's transfused from completion of study drug administration though midnight of the next day.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States