BleedingPhase 4NCT02557672

PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding

A Phase 4 study testing Prothrombin complex concentrate (Human) and Fresh frozen plasma (FFP) in people with Bleeding and Blood Loss, Surgical, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Bleeding, Blood Loss, Surgical, Cardiovascular Surgical Procedures
What is being tested?: Prothrombin complex concentrate (Human) and Fresh frozen plasma (FFP)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106 participants
Where: 1 siteUnited States
Study dates: Aug 2016to Jan 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 13Show fewer

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 locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for Post-cardiopulmonary Bypass Coagulopathy and Bleeding, a Prospective Randomized Trial at Large US Medical Center.

Conditions: Bleeding, Blood Loss, Surgical, Cardiovascular Surgical Procedures, Prothrombin Complex Concentrates, Fresh Frozen Plasma
Being tested: Prothrombin complex concentrate (Human), Fresh frozen plasma (FFP)
Medical subject headings: Hemorrhage, Blood Loss, Surgical

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prothrombin complex concentrate (Human)Drug
Also called Kcentra
PCC (Kcentra)
Fresh frozen plasma (FFP)Biological
FFP

Study groups in NCT02557672
Study group	Role	What they receive
Fresh frozen plasma	Active comparator	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. Receives: Biological: Fresh frozen plasma (FFP)
Prothrombin complex concentrate	Experimental	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. Receives: Drug: Prothrombin complex concentrate (Human)

What is being measured

The primary outcome is the main question the study is designed to answer.

Chest Tube Output
The amount of chest tube drainage output from after surgery through midnight of the next day. As measured in mL.
Measured: 24 hours
Red Blood Cell (RBC) Blood Product Transfusion
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.
Measured: 24 hours
Platelets Blood Product Transfusion
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.
Measured: 24 hours
Cryoprecipitate (Cryo) Blood Product Transfusion
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.
Measured: 24 hours
Fresh Frozen Plasma (FFP) Blood Product Transfusion
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.
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2016Jan 2022

First posted23 Sep 2015 (estimated)
Study startAug 2016
Primary completionJun 2021
Study completionJan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (20)Papers the sponsor has linked to this study.
Other trials for BleedingStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02557672
Sponsor's protocol ID: 14-009579
Status last verified: May 2022
First submitted: 21 Sep 2015
Last updated: 7 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Arnekian V, Camous J, Fattal S, Rezaiguia-Delclaux S, Nottin R, Stephan F. Use of prothrombin complex concentrate for excessive bleeding after cardiac surgery. Interact Cardiovasc Thorac Surg. 2012 Sep;15(3):382-9. doi: 10.1093/icvts/ivs224. Epub 2012 May 23.
PubMed 22623627
Ballotta A, Saleh HZ, El Baghdady HW, Gomaa M, Belloli F, Kandil H, Balbaa Y, Bettini F, Bossone E, Menicanti L, Frigiola A, Bellucci C, Mehta RH. Comparison of early platelet activation in patients undergoing on-pump versus off-pump coronary artery bypass surgery. J Thorac Cardiovasc Surg. 2007 Jul;134(1):132-8. doi: 10.1016/j.jtcvs.2007.01.055.
PubMed 17599498
Demeyere R, Gillardin S, Arnout J, Strengers PF. Comparison of fresh frozen plasma and prothrombin complex concentrate for the reversal of oral anticoagulants in patients undergoing cardiopulmonary bypass surgery: a randomized study. Vox Sang. 2010 Oct;99(3):251-60. doi: 10.1111/j.1423-0410.2010.01339.x.
PubMed 20840339
Ferreira J, DeLosSantos M. The clinical use of prothrombin complex concentrate. J Emerg Med. 2013 Jun;44(6):1201-10. doi: 10.1016/j.jemermed.2012.12.022. Epub 2013 Apr 18.
PubMed 23602147
Goldberg AD, Kor DJ. State of the art management of transfusion-related acute lung injury (TRALI). Curr Pharm Des. 2012;18(22):3273-84. doi: 10.2174/1381612811209023273.
PubMed 22621274
Gorlinger K, Dirkmann D, Hanke AA, Kamler M, Kottenberg E, Thielmann M, Jakob H, Peters J. First-line therapy with coagulation factor concentrates combined with point-of-care coagulation testing is associated with decreased allogeneic blood transfusion in cardiovascular surgery: a retrospective, single-center cohort study. Anesthesiology. 2011 Dec;115(6):1179-91. doi: 10.1097/ALN.0b013e31823497dd.
PubMed 21970887
Hajjar LA, Vincent JL, Galas FR, Nakamura RE, Silva CM, Santos MH, Fukushima J, Kalil Filho R, Sierra DB, Lopes NH, Mauad T, Roquim AC, Sundin MR, Leao WC, Almeida JP, Pomerantzeff PM, Dallan LO, Jatene FB, Stolf NA, Auler JO Jr. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. JAMA. 2010 Oct 13;304(14):1559-67. doi: 10.1001/jama.2010.1446.
PubMed 20940381
Hanke AA, Joch C, Gorlinger K. Long-term safety and efficacy of a pasteurized nanofiltrated prothrombin complex concentrate (Beriplex P/N): a pharmacovigilance study. Br J Anaesth. 2013 May;110(5):764-72. doi: 10.1093/bja/aes501. Epub 2013 Jan 18.
PubMed 23335567
Holbrook A, Schulman S, Witt DM, Vandvik PO, Fish J, Kovacs MJ, Svensson PJ, Veenstra DL, Crowther M, Guyatt GH. Evidence-based management of anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e152S-e184S. doi: 10.1378/chest.11-2295.
PubMed 22315259
Kaatz S, Kouides PA, Garcia DA, Spyropolous AC, Crowther M, Douketis JD, Chan AK, James A, Moll S, Ortel TL, Van Cott EM, Ansell J. Guidance on the emergent reversal of oral thrombin and factor Xa inhibitors. Am J Hematol. 2012 May;87 Suppl 1:S141-5. doi: 10.1002/ajh.23202. Epub 2012 Apr 4.
PubMed 22473649
Levy JH, Faraoni D, Spring JL, Douketis JD, Samama CM. Managing new oral anticoagulants in the perioperative and intensive care unit setting. Anesthesiology. 2013 Jun;118(6):1466-74. doi: 10.1097/ALN.0b013e318289bcba.
PubMed 23416382
Nuttall GA, Oliver WC, Santrach PJ, Bryant S, Dearani JA, Schaff HV, Ereth MH. Efficacy of a simple intraoperative transfusion algorithm for nonerythrocyte component utilization after cardiopulmonary bypass. Anesthesiology. 2001 May;94(5):773-81; discussion 5A-6A. doi: 10.1097/00000542-200105000-00014.
PubMed 11388527
Pandey S, Vyas GN. Adverse effects of plasma transfusion. Transfusion. 2012 May;52 Suppl 1(Suppl 1):65S-79S. doi: 10.1111/j.1537-2995.2012.03663.x.
PubMed 22578374
ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
PubMed 22797452
Thiele RH, Raphael J. A 2014 Update on Coagulation Management for Cardiopulmonary Bypass. Semin Cardiothorac Vasc Anesth. 2014 Jun;18(2):177-89. doi: 10.1177/1089253214534782.
PubMed 24876232

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion

All Bleeding trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for Post-cardiopulmonary Bypass Coagulopathy and Bleeding, a Prospective Randomized Trial at Large US Medical Center.
ClinicalTrials.gov ID: NCT02557672
Acronym / sponsor ID: 14-009579
Conditions: Bleeding, Blood Loss, Surgical, Cardiovascular Surgical Procedures, Prothrombin Complex Concentrates, Fresh Frozen Plasma
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: CSL Behring
Study start: Aug 2016 (actual)
Primary completion: Jun 2021 (actual)
Study completion: Jan 2022 (actual)
First posted: 23 Sep 2015 (estimated)
Results: Posted 7 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fresh frozen plasma	Active comparator	Biological: 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	Experimental	Drug: 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Prothrombin complex concentrate (Human)Also: KcentraPCC (Kcentra)	Drug	Prothrombin complex concentrate
Fresh frozen plasma (FFP)FFP	Biological	Fresh frozen plasma

Primary outcome

Chest Tube Output
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 7 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fresh Frozen Plasma	53	49
Prothrombin Complex Concentrate	53	51

Primary outcome: Chest Tube Output

Time frame: 24 hours. Median (Inter-Quartile Range). Unit: mL

Measure	Fresh Frozen Plasma n = 48	Prothrombin Complex Concentrate n = 51
Value	1022 (799 to 1575)	937 (708 to 1443)

Fresh Frozen Plasma vs Prothrombin Complex Concentrate: Ratio of the Geometric Means: 0.98 (95% CI 0.81 to 1.19), p = 0.84, Regression, Linear

Population analysed: 1 subject's data was not collected nor analyzed for the FFP arm

Primary outcome: Red Blood Cell (RBC) Blood Product Transfusion

Time frame: 24 hours. Count of participants. Unit: Participants

Measure	Fresh Frozen Plasma n = 48	Prothrombin Complex Concentrate n = 51
0 units	26	36
1 unit	11	8
2 units	6	5
3 or more units	5	2

Fresh Frozen Plasma vs Prothrombin Complex Concentrate: Odds Ratio (OR): 0.49 (95% CI 0.22 to 1.11), p = 0.09, Regression, Logistic

Population analysed: 1 subject data was not collected nor analyzed for the FFP arm

Primary outcome: Platelets Blood Product Transfusion

Time frame: 24 hours. Count of participants. Unit: Participants

Measure	Fresh Frozen Plasma n = 48	Prothrombin Complex Concentrate n = 51
0 units	30	36
1 unit	13	9
2 units	3	3
3 or more units	2	3

Fresh Frozen Plasma vs Prothrombin Complex Concentrate: Odds Ratio, log: 0.76 (95% CI 0.33 to 1.73), p = 0.51, Regression, Logistic

Population analysed: 1 subject's data was not collected nor analyzed for the FFP arm

Primary outcome: Cryoprecipitate (Cryo) Blood Product Transfusion

Time frame: 24 hours. Count of participants. Unit: Participants

Measure	Fresh Frozen Plasma n = 48	Prothrombin Complex Concentrate n = 51
0 units	40	40
1 unit	2	2
2 units	5	8
3 or more units	1	1

Fresh Frozen Plasma vs Prothrombin Complex Concentrate: Odds Ratio (OR): 1.39 (95% CI 0.51 to 3.79), p = 0.53, Regression, Logistic

Population analysed: 1 subject's data was not collected nor analyzed for the FFP arm

Adverse events

Time frame: Adverse Events were collected for each subject from baseline to end of study, approximately 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fresh Frozen Plasma	44 of 49 (89.8%)	0 of 49 (0%)	2 of 49
Prothrombin Complex Concentrate	45 of 51 (88.2%)	0 of 51 (0%)	1 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22623627Arnekian V, Camous J, Fattal S, Rezaiguia-Delclaux S, Nottin R, Stephan F. Use of prothrombin complex concentrate for excessive bleeding after cardiac surgery. Interact Cardiovasc Thorac Surg. 2012 Sep;15(3):382-9. doi: 10.1093/icvts/ivs224. Epub 2012 May 23.
Background: PubMed 17599498Ballotta A, Saleh HZ, El Baghdady HW, Gomaa M, Belloli F, Kandil H, Balbaa Y, Bettini F, Bossone E, Menicanti L, Frigiola A, Bellucci C, Mehta RH. Comparison of early platelet activation in patients undergoing on-pump versus off-pump coronary artery bypass surgery. J Thorac Cardiovasc Surg. 2007 Jul;134(1):132-8. doi: 10.1016/j.jtcvs.2007.01.055.
Background: PubMed 20840339Demeyere R, Gillardin S, Arnout J, Strengers PF. Comparison of fresh frozen plasma and prothrombin complex concentrate for the reversal of oral anticoagulants in patients undergoing cardiopulmonary bypass surgery: a randomized study. Vox Sang. 2010 Oct;99(3):251-60. doi: 10.1111/j.1423-0410.2010.01339.x.
Background: PubMed 23602147Ferreira J, DeLosSantos M. The clinical use of prothrombin complex concentrate. J Emerg Med. 2013 Jun;44(6):1201-10. doi: 10.1016/j.jemermed.2012.12.022. Epub 2013 Apr 18.
Background: PubMed 22621274Goldberg AD, Kor DJ. State of the art management of transfusion-related acute lung injury (TRALI). Curr Pharm Des. 2012;18(22):3273-84. doi: 10.2174/1381612811209023273.
Background: PubMed 21970887Gorlinger K, Dirkmann D, Hanke AA, Kamler M, Kottenberg E, Thielmann M, Jakob H, Peters J. First-line therapy with coagulation factor concentrates combined with point-of-care coagulation testing is associated with decreased allogeneic blood transfusion in cardiovascular surgery: a retrospective, single-center cohort study. Anesthesiology. 2011 Dec;115(6):1179-91. doi: 10.1097/ALN.0b013e31823497dd.
Background: PubMed 20940381Hajjar LA, Vincent JL, Galas FR, Nakamura RE, Silva CM, Santos MH, Fukushima J, Kalil Filho R, Sierra DB, Lopes NH, Mauad T, Roquim AC, Sundin MR, Leao WC, Almeida JP, Pomerantzeff PM, Dallan LO, Jatene FB, Stolf NA, Auler JO Jr. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. JAMA. 2010 Oct 13;304(14):1559-67. doi: 10.1001/jama.2010.1446.
Background: PubMed 23335567Hanke AA, Joch C, Gorlinger K. Long-term safety and efficacy of a pasteurized nanofiltrated prothrombin complex concentrate (Beriplex P/N): a pharmacovigilance study. Br J Anaesth. 2013 May;110(5):764-72. doi: 10.1093/bja/aes501. Epub 2013 Jan 18.
Background: PubMed 22315259Holbrook A, Schulman S, Witt DM, Vandvik PO, Fish J, Kovacs MJ, Svensson PJ, Veenstra DL, Crowther M, Guyatt GH. Evidence-based management of anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e152S-e184S. doi: 10.1378/chest.11-2295.
Background: PubMed 22473649Kaatz S, Kouides PA, Garcia DA, Spyropolous AC, Crowther M, Douketis JD, Chan AK, James A, Moll S, Ortel TL, Van Cott EM, Ansell J. Guidance on the emergent reversal of oral thrombin and factor Xa inhibitors. Am J Hematol. 2012 May;87 Suppl 1:S141-5. doi: 10.1002/ajh.23202. Epub 2012 Apr 4.
Background: PubMed 23416382Levy JH, Faraoni D, Spring JL, Douketis JD, Samama CM. Managing new oral anticoagulants in the perioperative and intensive care unit setting. Anesthesiology. 2013 Jun;118(6):1466-74. doi: 10.1097/ALN.0b013e318289bcba.
Background: PubMed 11388527Nuttall GA, Oliver WC, Santrach PJ, Bryant S, Dearani JA, Schaff HV, Ereth MH. Efficacy of a simple intraoperative transfusion algorithm for nonerythrocyte component utilization after cardiopulmonary bypass. Anesthesiology. 2001 May;94(5):773-81; discussion 5A-6A. doi: 10.1097/00000542-200105000-00014.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Bleeding

Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gregory Nuttall, MD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Prothrombin complex concentrate (Human) and Fresh frozen plasma (FFP) in people with Bleeding and Blood Loss, Surgical, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chest Tube Output (time frame: 24 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02557672, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.