NCT01060189

Brief Summary

Antifibrinolytic drugs are used to decrease perioperative bleeding and allogeneic transfusions. The extensively studied antifibrinolytic drug aprotinin is efficacious but expensive, and has been proved to link to higher risks of serious side effects including renal problems, myocardial events, and strokes in patients undergoing CABG. After the secession of aprotinin in 2007, a marked increase of blood loss and transfusions in cardiac surgery took place. An effective and secure hemostatic agent is badly needed. Ulinastatin, urinary trypsin inhibitor(UTI), is a secreted Kunitz-type protease inhibitor with a wide inhibition spectrum, including plasmin. Limited studies offered clues to its antifibrinolytic effect. Tranexamic acid has been applied for years with convinced efficacy and safety. The objective of the study is to evaluate the hemostatic effect of ulinastatin and tranexamic acid in cardiac surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
426

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
8.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

9 months

First QC Date

January 28, 2010

Last Update Submit

February 2, 2019

Conditions

Hemostasis

Keywords

ulinastatintranexamic acidcardiac surgery procedureshemostasis

Outcome Measures

Primary Outcomes (1)

  • Postoperative blood loss

    Defined as the total volume of chest drainage postoperatively

    Postoperatively

Secondary Outcomes (6)

  • Rate of reexploration for bleeding

    Postoperatively

  • Rate of major bleeding

    Perioperatively

  • Transfusion of allogeneic erythrocytes

    Perioperatively

  • Transfusion of fresh frozen plasma (FFP)

    Perioperatively

  • Transfusion of allogeneic platelets

    Perioperatively

  • +1 more secondary outcomes

Study Arms (3)

Ulinastatin

EXPERIMENTAL

1,000,000 units of ulinastatin in 50ml solution before skin incision; 50ml saline solution after neutralization

Drug: Ulinastatin

Tranexamic Acid

EXPERIMENTAL

15mg/kg tranexamic acid in 50ml solution before skin incision; 15mg/kg tranexamic acid in 50ml solution after neutralization

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

50ml saline solution before skin incision; 50ml saline solution after neutralization

Drug: Saline Solution

Interventions

UlinastatinDRUG
Ulinastatin
Tranexamic AcidDRUG
Tranexamic Acid
Saline SolutionDRUG
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Atrial or ventricular septum defect patients requiring cardiac surgery with CPB
  • Rheumatic or recessive valvular patients requiring valvular repair or replacement with CPB
  • Coronary artery disease patients requiring coronary revascularization surgery with CPB

You may not qualify if:

  • Non-primary cardiac surgery
  • Definite liver or renal dysfunction
  • Disorder in coagulation function
  • Allergy
  • Pregnancy or lactation
  • Disabled in spirit or law
  • Fatal conditions such as tumour

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (1)

  • Zhang P, Lv H, Qi X, Xiao W, Xue Q, Zhang L, Li L, Shi J. 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. J Cardiothorac Surg. 2020 May 14;15(1):98. doi: 10.1186/s13019-020-01144-9.

    PMID: 32410683DERIVED

MeSH Terms

Interventions

urinastatinTranexamic AcidSaline Solution

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Lihuan Li, MD

    Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

    STUDY CHAIR

  • Jia Shi, MD

    Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor and Vice Chair of department of anesthesiology, Fuwai Hospital, NCCD, PUMC & CAMS

Study Record Dates

First Submitted

January 28, 2010

First Posted

February 2, 2010

Study Start

April 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2019

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations

CN(1)