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Effect of ulinastatin on post-operative blood loss and allogeneic transfusion in patients receiving cardiac surgery with cardiopulmonary bypass: a prospective randomized controlled study with 10-year follow-up
Jia Shi
Chinese Academy of Medical Sciences & Peking Union Medical College Fuwai Hospital
Corresponding Author
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Background: Major bleeding and allogeneic transfusion leads to negative outcomes in patients receiving cardiac surgery with cardiopulmonary bypass (CPB). Ulinastatin, a urine trypsin inhibitor, relieves systemic inflammation and improves coagulation profiles with however sparse evidence of its effects on blood loss and allogeneic transfusion in this specific population.
Methods: In this prospective randomized controlled trial, 426 consecutive patients receiving open heart surgery with CPB were randomly assigned into three groups to receive ulinastatin (group U, n=142), tranexamic acid (group T, n=143) or normal saline (group C, n=141). The primary outcome was the total volume of post-operative bleeding and the secondary outcome included the volume and exposure of allogeneic transfusion, the incidence of stroke, post-operative myocardial infarction, renal failure, respiratory failure and all-cause mortality. A ten-year follow-up was carried on to evaluate long-term safety.
Results: Compared with placebo, ulinastatin significantly reduced the volume of post-operative blood loss within 24 hours (688.39±393.55ml vs 854.33±434.03ml MD -165.95ml, 95%CI -262.88ml to -69.01ml, p<0.001) and the volume of allogeneic erythrocyte transfusion (2.57±3.15 unit vs 3.73±4.21 unit, MD-1.16 unit, 95%CI -2.06 units to -0.26 units, p=0.002). The bleeding and transfusion outcomes were comparable between the ulinastatin group and the tranexamic acid group. In-hospital outcomes and 10-year follow-up showed no statistical difference in mortality and major morbidity among groups.
Conclusions: Ulinastatin reduced post-operative blood loss and allogeneic erythrocyte transfusion in heart surgery with CPB. The mortality and major morbidity was comparable among the groups shown by the 10-year follow-up.
Trial registration: The trial was retrospectively registered on February 2, 2010. Trial registration number: https://www.clinicaltrials.gov. Identifier: NCT01060189.
Keywords
ulinastatin, tranexamic acid, blood conservation, cardiopulmonary bypass
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CURRENT STATUS: Under Review
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Posted 15 May, 2020
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Editor assigned
On 29 Apr, 2020
Submission checks complete
On 28 Apr, 2020
Editor invited
On 28 Apr, 2020
No comments provided
Editorial decision: Major revision
On 04 Apr, 2020
Review #2 received
Received 03 Apr, 2020
Review #5 received
Received 29 Mar, 2020
Review #4 received
Received 29 Mar, 2020
Reviewer #5 agreed
On 26 Mar, 2020
Reviewer #4 agreed
On 25 Mar, 2020
Review #1 received
Received 25 Mar, 2020
Reviewer #3 agreed
On 25 Mar, 2020
Review #3 received
Received 25 Mar, 2020
Reviewer #2 agreed
On 23 Mar, 2020
Reviewers invited
Invitations sent on 22 Mar, 2020
Reviewer #1 agreed
On 22 Mar, 2020
Editor assigned
On 21 Feb, 2020
First submitted
On 20 Feb, 2020
Submission checks complete
On 20 Feb, 2020
Editor invited
On 20 Feb, 2020
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This preprint is under consideration at Journal of Cardiothoracic Surgery. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Effect of ulinastatin on post-operative blood loss and allogeneic transfusion in patients receiving cardiac surgery with cardiopulmonary bypass: a prospective randomized controlled study with 10-year follow-up
Jia Shi
Chinese Academy of Medical Sciences & Peking Union Medical College Fuwai Hospital
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 2
Posted 15 May, 2020
No community comments so far
Editor assigned
On 29 Apr, 2020
Submission checks complete
On 28 Apr, 2020
Editor invited
On 28 Apr, 2020
No comments provided
Editorial decision: Major revision
On 04 Apr, 2020
Review #2 received
Received 03 Apr, 2020
Review #5 received
Received 29 Mar, 2020
Review #4 received
Received 29 Mar, 2020
Reviewer #5 agreed
On 26 Mar, 2020
Reviewer #4 agreed
On 25 Mar, 2020
Review #1 received
Received 25 Mar, 2020
Reviewer #3 agreed
On 25 Mar, 2020
Review #3 received
Received 25 Mar, 2020
Reviewer #2 agreed
On 23 Mar, 2020
Reviewers invited
Invitations sent on 22 Mar, 2020
Reviewer #1 agreed
On 22 Mar, 2020
Editor assigned
On 21 Feb, 2020
First submitted
On 20 Feb, 2020
Submission checks complete
On 20 Feb, 2020
Editor invited
On 20 Feb, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Major bleeding and allogeneic transfusion leads to negative outcomes in patients receiving cardiac surgery with cardiopulmonary bypass (CPB). Ulinastatin, a urine trypsin inhibitor, relieves systemic inflammation and improves coagulation profiles with however sparse evidence of its effects on blood loss and allogeneic transfusion in this specific population.
Methods: In this prospective randomized controlled trial, 426 consecutive patients receiving open heart surgery with CPB were randomly assigned into three groups to receive ulinastatin (group U, n=142), tranexamic acid (group T, n=143) or normal saline (group C, n=141). The primary outcome was the total volume of post-operative bleeding and the secondary outcome included the volume and exposure of allogeneic transfusion, the incidence of stroke, post-operative myocardial infarction, renal failure, respiratory failure and all-cause mortality. A ten-year follow-up was carried on to evaluate long-term safety.
Results: Compared with placebo, ulinastatin significantly reduced the volume of post-operative blood loss within 24 hours (688.39±393.55ml vs 854.33±434.03ml MD -165.95ml, 95%CI -262.88ml to -69.01ml, p<0.001) and the volume of allogeneic erythrocyte transfusion (2.57±3.15 unit vs 3.73±4.21 unit, MD-1.16 unit, 95%CI -2.06 units to -0.26 units, p=0.002). The bleeding and transfusion outcomes were comparable between the ulinastatin group and the tranexamic acid group. In-hospital outcomes and 10-year follow-up showed no statistical difference in mortality and major morbidity among groups.
Conclusions: Ulinastatin reduced post-operative blood loss and allogeneic erythrocyte transfusion in heart surgery with CPB. The mortality and major morbidity was comparable among the groups shown by the 10-year follow-up.
Trial registration: The trial was retrospectively registered on February 2, 2010. Trial registration number: https://www.clinicaltrials.gov. Identifier: NCT01060189.
Figure 1
Figure 2