Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery
NCT ID: NCT04244981
Last Updated: 2025-10-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE4
Total Enrollment
820 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-10-25
Study Completion Date
2025-10-31
Brief Summary
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This study is a non-inferiority, randomized controlled trial, based on the hypothesis that 4-factor PCC is not inferior to FFP in reducing perioperative blood loss in patients undergoing cardiac surgery under cardiopulmonary bypass. 816 subjects will be randomly divided into 2 groups (group PCC and group FFP), with 408 cases in each group. Patients will be given 8\~15 IU/kg 4-factor PCC in group PCC and 6\~10 ml/kg FFP in group FFP. All the patients will be followed up respectively at 24 hours, 48 hours, 72 hours and 7 days after the surgery. The primary outcome is the volume of blood loss within 24 hours after surgery. The secondary outcomes include (1) the total units of allogeneic red blood cells (RBCs) transfused within 7 days after surgery and (2) hemostatic response (effective if no hemostatic interventions occurred from 60 minutes to 24 hours after treatment initiation). Adverse events and serious adverse events will be monitored as safety outcomes.
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Detailed Description
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Perioperative blood loss and allogeneic blood transfusion are major complications of cardiac surgery, which increase perioperative complications, perioperative mortality and medical costs. This study addresses the unmet need for optimizing coagulation management in cardiac surgery by comparing the efficacy and safety of 4-factor prothrombin complex concentrates (PCC) and fresh frozen plasma (FFP). he trial is designed as a non-inferiority, randomized controlled study to assess whether PCC is non-inferior to FFP in reducing perioperative blood loss and transfusion needs in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). Patients who signed informed consent, aged 18 to 80 years, receiving elective CABG or valve replacement or valvuloplasty under CPB will be included. 816 subjects will be randomly divided into 2 groups (PCC group and FFP group), with 408 cases in each group. Preoperative management, anesthetic and surgical techniques will be standardized for both groups. When activated partial thromboplastin time (APTT) is prolonged (\> 45 s), patients will be given 8\~15 IU/kg PCC or 6\~10 ml/kg FFP according to the allocation. All the patients will be followed up respectively at 24 hours, 48 hours, 72 hours and 7 days after the surgery to record observations relevant to the study and the results of laboratory testing. The laboratory tests include hemoglobin concentration, hematocrit, platelet count, INR, PT, APTT, fibrinogen levels and blood biochemistry parameters. The primary outcome is the volume of blood loss within 24 hours after surgery. The secondary outcomes include (1) the total units of allogeneic red blood cells (RBCs) transfused within 7 days after surgery and (2) hemostatic response (effective if no hemostatic interventions occurred from 60 minutes to 24 hours after treatment initiation). Adverse events and serious adverse events will be monitored as safety outcomes.
Modified intent-to-treat analysis will be used for all valid variables. All randomised subjects in the study, regardless of adherence to the study process or whether an adverse event occurs before or after the intervention, should be included in the analysis. Sensitivity analysis will be performed to assess potential bias from protocol deviations or missing data. Baseline characteristics will be tabulated and compared between the PCC and FFP groups using absolute standardised differences, and the threshold will be calculated using the formula (1.96×√\[n1+n2\]/\[n1×n2\]). A value exceeding this threshold will be considered imbalanced between groups. Unbalanced baseline factors and different study centers will be further adjusted by multivariable regression models.
The primary outcome, the volume of blood loss within 24 hours after surgery, will be compared using one-tailed ttest. If there exists unbalanced baseline characteristics, the treatment effect (difference in means between the PCC and FFP groups) will be estimated using a linear regression model adjusted for centers and any imbalanced baseline covariates. The non-inferiority test will be conducted using the estimated difference minus the non-inferiority margin (200 mL) in the numerator, and the estimated standard error of the difference in the denominator. Non-inferiority will be concluded if the upper bound of the 99.7% confidence interval was below the predefined non-inferiority margin of 200 mL, corresponding to a one-sided P value \< 0.025. For the continuous secondary outcome, the total units of allogeneic RBCs transfused during and within 7 days after surgery will be compared using a t-test with log transformation of the variable. The rate of hemostatic response will be compared using the chi-square test. Treatment effects will be reported as risk ratios and mean differences for binary and continuous outcomes respectively with 95% confidence intervals. If there exists unbalanced baseline characteristics, the secondary outcomes will be regressed against the group allocation, centers and the unbalanced factors using linear regression or Poisson regression models. The following subgroups will be analysed: age (\<65 years/ ≥65 years), gender (male/female), study center, NYHA class (I and II/III and IV), surgery type (simple/complex surgery) and CPB duration (≤120 minutes, 121-180 minutes, \>180 minutes). For safety outcomes, we will only describe the incidence of overall adverse events, SAEs, and component adverse events without statistical tests between two groups. A two-sided P-value \< 0.05 was considered indicative of statistical significance.
Our independent Data Safety Monitoring Board (DSMB), which includes an epidemiologist, a pharmacologist, an anesthesiologist, and a blood transfusion specialist, conducted an interim review of our study. Considering the shortage of blood resources and the difficulties in large-sample recruitment, the DSMB recommended adding an interim analysis. Therefore, an interim analysis was planned after 50% of the target enrollment had been achieved. o ensure statistical rigor, the Lan-DeMets alpha-spending approach with O'Brien-Fleming boundaries was implemented for interim efficacy and futility evaluation, offering conservative thresholds early in the trial. With the same standard deviation (824.38 mL) and the superior margin (200 mL) is, as well as the 90% power and 10% dropout rate, we recalculated the sample size and found out that 816 patients in total should be recruited. Thus our interim analysis will be conducted when 408 patients recruited.
Modified intent-to-treat analysis will be used for all valid variables. All randomised subjects in the study, regardless of adherence to the study process or whether an adverse event occurs before or after the intervention, should be included in the analysis. Sensitivity analysis will be performed to assess potential bias from protocol deviations or missing data. Baseline characteristics will be tabulated and compared between the PCC and FFP groups using absolute standardised differences, and the threshold will be calculated using the formula (1.96×√\[n1+n2\]/\[n1×n2\]). A value exceeding this threshold will be considered imbalanced between groups. Unbalanced baseline factors and different study centers will be further adjusted by multivariable regression models.
The primary outcome, the volume of blood loss within 24 hours after surgery, will be compared using one-tailed ttest. If there exists unbalanced baseline characteristics, the treatment effect (difference in means between the PCC and FFP groups) will be estimated using a linear regression model adjusted for centers and any imbalanced baseline covariates. The non-inferiority test will be conducted using the estimated difference minus the non-inferiority margin (200 mL) in the numerator, and the estimated standard error of the difference in the denominator. Non-inferiority will be concluded if the upper bound of the 99.7% confidence interval was below the predefined non-inferiority margin of 200 mL, corresponding to a one-sided P value \< 0.025. For the continuous secondary outcome, the total units of allogeneic RBCs transfused during and within 7 days after surgery will be compared using a t-test with log transformation of the variable. The rate of hemostatic response will be compared using the chi-square test. Treatment effects will be reported as risk ratios and mean differences for binary and continuous outcomes respectively with 95% confidence intervals. If there exists unbalanced baseline characteristics, the secondary outcomes will be regressed against the group allocation, centers and the unbalanced factors using linear regression or Poisson regression models. The following subgroups will be analysed: age (\<65 years/ ≥65 years), gender (male/female), study center, NYHA class (I and II/III and IV), surgery type (simple/complex surgery) and CPB duration (≤120 minutes, 121-180 minutes, \>180 minutes). For safety outcomes, we will only describe the incidence of overall adverse events, SAEs, and component adverse events without statistical tests between two groups. A two-sided P-value \< 0.05 was considered indicative of statistical significance.
Our independent Data Safety Monitoring Board (DSMB), which includes an epidemiologist, a pharmacologist, an anesthesiologist, and a blood transfusion specialist, conducted an interim review of our study. Considering the shortage of blood resources and the difficulties in large-sample recruitment, the DSMB recommended adding an interim analysis. Therefore, an interim analysis was planned after 50% of the target enrollment had been achieved. o ensure statistical rigor, the Lan-DeMets alpha-spending approach with O'Brien-Fleming boundaries was implemented for interim efficacy and futility evaluation, offering conservative thresholds early in the trial. With the same standard deviation (824.38 mL) and the superior margin (200 mL) is, as well as the 90% power and 10% dropout rate, we recalculated the sample size and found out that 816 patients in total should be recruited. Thus our interim analysis will be conducted when 408 patients recruited.
Conditions
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Cardiac Surgical Procedures
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
816 patients who meet the criteria will be randomly divided into 2 groups, named prothrombin complex concentrate group (group PCC) and fresh frozen plasma group (control group, group FFP), with 408 cases in each group. Preoperative management, anesthetic and surgical techniques will be standardized for all patients. Prolonged APTT (\> 45 s) will be regarded as a trigger for administration of PCC or FFP, according to the randomized groups. In group PCC, patients will be given 8\~15 IU/kg PCC. In group FFP, patients will be given 6\~10 mL/kg FFP.
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Outcome Assessors
Allocation will be concealed using an interactive web response system, and nurse anaesthetists will prepare the corresponding products for each patient according to the group assignments in an anaesthesia preparation room. PCC or FFP will be pumped into 50 ml syringes firstly, covered with opaque paper to hide the contents. For group PCC, we first diluted PCC to 50ml with normal saline, and then supplemented subsequent volume using normal saline to make it equal to the corresponding required volume of FFP.
Study Groups
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PCC group
When APTT is prolonged (\> 45 s) measured 20 minutes after CPB or excessive bleeding observed, patients will be given 8～15 IU/kg PCC.
Group Type
EXPERIMENTAL
Prothrombin Complex Concentrate, Human
Intervention Type
DRUG
Four types of 4-factor prothrombin complex concentrate will be used.
1. Human Prothrombin Complex (Rongsheng Pharmaceuticals Co., Ltd.), containing 300 IU factor IX, 300 IU factor II, 120 IU factor VII, and 300 IU factor X each bottle.
2. Human Prothrombin Complex (China Resources Boya Biopharmaceutical Group Co., Ltd.), containing 400 IU factor IX, 400 IU factor II, 200 IU factor VII, and 400 IU factor X each bottle.
3. Human Prothrombin Complex (Hualan Biological Engineering, INC.), containing 300 IU factor IX, 300 IU factor II, 75 IU factor VII, and 300 IU factor X each bottle.
4. Human Prothrombin Complex (Shandong Taibang Biological Products Co., Ltd.), containing 300 IU factor IX, 300 IU factor II, 210 IU factor VII, and 300 IU factor X each bottle.
When APTT is prolonged (\> 45 s) measured 20 minutes after CPB or excessive bleeding observed, patients will be given 8～15 IU/kg PCC.
FFP group
When APTT is prolonged (\> 45 s) measured 20 minutes after CPB or excessive bleeding observed, patients will be given 6～10 mL/kg FFP.
Group Type
ACTIVE_COMPARATOR
Fresh Frozen Plasma
Intervention Type
DRUG
When APTT is prolonged (\> 45 s) measured 20 minutes after CPB or excessive bleeding observed, patients will be given 6～10 mL/kg FFP.
Interventions
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Prothrombin Complex Concentrate, Human
Four types of 4-factor prothrombin complex concentrate will be used.
1. Human Prothrombin Complex (Rongsheng Pharmaceuticals Co., Ltd.), containing 300 IU factor IX, 300 IU factor II, 120 IU factor VII, and 300 IU factor X each bottle.
2. Human Prothrombin Complex (China Resources Boya Biopharmaceutical Group Co., Ltd.), containing 400 IU factor IX, 400 IU factor II, 200 IU factor VII, and 400 IU factor X each bottle.
3. Human Prothrombin Complex (Hualan Biological Engineering, INC.), containing 300 IU factor IX, 300 IU factor II, 75 IU factor VII, and 300 IU factor X each bottle.
4. Human Prothrombin Complex (Shandong Taibang Biological Products Co., Ltd.), containing 300 IU factor IX, 300 IU factor II, 210 IU factor VII, and 300 IU factor X each bottle.
When APTT is prolonged (\> 45 s) measured 20 minutes after CPB or excessive bleeding observed, patients will be given 8～15 IU/kg PCC.
Intervention Type
DRUG
Fresh Frozen Plasma
When APTT is prolonged (\> 45 s) measured 20 minutes after CPB or excessive bleeding observed, patients will be given 6～10 mL/kg FFP.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Age between 18 and 80 years.
2. Undergoing elective coronary artery bypass grafting (CABG) or valve replacement or valvuloplasty through CPB.
3. Signing of the informed consent form.
4. Developing coagulation factor deficiency or coagulopathic bleeding during the surgery, meeting the indications of PCC or FFP treatment: a) prolonged APTT (\> 45 s) measured 20 minutes after CPB, and b) excessive bleeding observed.
2. Undergoing elective coronary artery bypass grafting (CABG) or valve replacement or valvuloplasty through CPB.
3. Signing of the informed consent form.
4. Developing coagulation factor deficiency or coagulopathic bleeding during the surgery, meeting the indications of PCC or FFP treatment: a) prolonged APTT (\> 45 s) measured 20 minutes after CPB, and b) excessive bleeding observed.
Exclusion Criteria
1. History of cardiac surgery.
2. Severe hepatic dysfunction before surgery.
3. Coagulopathy before surgery, including inherited or acquired coagulation factor deficiencies, thrombocytopenia, platelet dysfunction and other bleeding disorders.
4. Use of warfarin and INR \> 1.2 before surgery.
5. Withdrawal of clopidogrel less than 5 days and low molecular weight heparin less than 12 hours before surgery.
6. Allergy to allogeneic blood products.
7. Pregnancy.
8. Other serious diseases that may affect patient survival time, such as cancers.
2. Severe hepatic dysfunction before surgery.
3. Coagulopathy before surgery, including inherited or acquired coagulation factor deficiencies, thrombocytopenia, platelet dysfunction and other bleeding disorders.
4. Use of warfarin and INR \> 1.2 before surgery.
5. Withdrawal of clopidogrel less than 5 days and low molecular weight heparin less than 12 hours before surgery.
6. Allergy to allogeneic blood products.
7. Pregnancy.
8. Other serious diseases that may affect patient survival time, such as cancers.
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Sponsor Role
collaborator
Beijing Anzhen Hospital
OTHER
Sponsor Role
collaborator
Guizhou Provincial People's Hospital
OTHER
Sponsor Role
collaborator
Zunyi Medical College
OTHER
Sponsor Role
collaborator
First Affiliated Hospital of Harbin Medical University
OTHER
Sponsor Role
collaborator
The First Affiliated Hospital of Air Force Medicial University
OTHER
Sponsor Role
collaborator
The Affiliated Hospital Of Guizhou Medical University
OTHER
Sponsor Role
collaborator
SHI Jia
OTHER
Sponsor Role
lead
Responsible Party
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SHI Jia
Vice Chair, the department of Anesthesiology
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Lijian Pei, M.D.
Role: STUDY_CHAIR
Peking Union Medical College Hospital
Jia Shi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Locations
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Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, China
Site Status
RECRUITING
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Site Status
RECRUITING
Countries
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China
Central Contacts
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Facility Contacts
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References
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Pabinger-Fasching I. Warfarin-reversal: results of a phase III study with pasteurised, nanofiltrated prothrombin complex concentrate. Thromb Res. 2008;122 Suppl 2:S19-22. doi: 10.1016/S0049-3848(08)70005-7.
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BACKGROUND
Nienaber U, Innerhofer P, Westermann I, Schochl H, Attal R, Breitkopf R, Maegele M. The impact of fresh frozen plasma vs coagulation factor concentrates on morbidity and mortality in trauma-associated haemorrhage and massive transfusion. Injury. 2011 Jul;42(7):697-701. doi: 10.1016/j.injury.2010.12.015. Epub 2011 Mar 9.
Reference Type
BACKGROUND
Goldstein JN, Refaai MA, Milling TJ Jr, Lewis B, Goldberg-Alberts R, Hug BA, Sarode R. Four-factor prothrombin complex concentrate versus plasma for rapid vitamin K antagonist reversal in patients needing urgent surgical or invasive interventions: a phase 3b, open-label, non-inferiority, randomised trial. Lancet. 2015 May 23;385(9982):2077-87. doi: 10.1016/S0140-6736(14)61685-8. Epub 2015 Feb 27.
Reference Type
BACKGROUND
Green L, Roberts N, Cooper J, Field J, Gill R, Klein A, Agarwal S, Stanworth S, Johnston A, Monk V, O'Brien B. A pragmatic pilot phase II randomised controlled trial of prothrombin complex concentrates (PCC) versus fresh frozen plasma (FFP) in adult patients who are undergoing heart surgery (PROPHESY). Trials. 2019 Dec 9;20(1):684. doi: 10.1186/s13063-019-3759-8.
Reference Type
BACKGROUND
Kozek-Langenecker SA, Afshari A, Albaladejo P, Santullano CA, De Robertis E, Filipescu DC, Fries D, Gorlinger K, Haas T, Imberger G, Jacob M, Lance M, Llau J, Mallett S, Meier J, Rahe-Meyer N, Samama CM, Smith A, Solomon C, Van der Linden P, Wikkelso AJ, Wouters P, Wyffels P. Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2013 Jun;30(6):270-382. doi: 10.1097/EJA.0b013e32835f4d5b.
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BACKGROUND
Hayes K, Fernando MC, Jordan V. Prothrombin complex concentrate in cardiac surgery for the treatment of coagulopathic bleeding. Cochrane Database Syst Rev. 2022 Nov 21;11(11):CD013551. doi: 10.1002/14651858.CD013551.pub2.
Reference Type
DERIVED
Pei L, Sun C, Lv H, Zhang Y, Shi J. Efficacy of prothrombin complex concentrate (PCC) versus fresh frozen plasma (FFP) in reducing perioperative blood loss in cardiac surgery: study protocol for a non-inferiority, randomised controlled trial. BMJ Open. 2022 Feb 10;12(2):e051072. doi: 10.1136/bmjopen-2021-051072.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PCC vs FFP Study
Identifier Type: -
Identifier Source: org_study_id
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