Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01060189
• Collaborator: (none)
• Enrollment: 426
• Location: 1
• Arms: 3
• Actual Duration (Months): 129
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemostasis	Drug: Ulinastatin; Drug: Tranexamic Acid; Drug: Saline Solution	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 426 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery With Cardiopulmonary Bypass: A Pilot Study
• Actual Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ulinastatin 1,000,000 units of ulinastatin in 50ml solution before skin incision; 50ml saline solution after neutralization	Drug: Ulinastatin
Experimental: Tranexamic Acid 15mg/kg tranexamic acid in 50ml solution before skin incision; 15mg/kg tranexamic acid in 50ml solution after neutralization	Drug: Tranexamic Acid
Placebo Comparator: Placebo 50ml saline solution before skin incision; 50ml saline solution after neutralization	Drug: Saline Solution

Outcome Measures

Primary Outcome Measures

1. Postoperative blood loss [Postoperatively]

   Defined as the total volume of chest drainage postoperatively

Secondary Outcome Measures

1. Rate of reexploration for bleeding [Postoperatively]

2. Rate of major bleeding [Perioperatively]

   Major bleeding is defined according to the CURE study

3. Transfusion of allogeneic erythrocytes [Perioperatively]

   Rate of exposure and volume of allogeneic erythrocytes transfused

4. Transfusion of fresh frozen plasma (FFP) [Perioperatively]

   Rate of exposure and volume of FFP transfused

5. Transfusion of allogeneic platelets [Perioperatively]

   Rate of exposure and volume of allogeneic platelets transfused

6. Length of stay in ICU and hospital postoperatively [Postoperatively]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC	Beijing	Beijing	China	100037

Sponsors and Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

• Study Chair: Lihuan Li, MD, Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
• Principal Investigator: Jia Shi, MD, Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SHI Jia, Associated Professor and Vice Chair of department of anesthesiology, Fuwai Hospital, NCCD, PUMC & CAMS, Chinese Academy of Medical Sciences, Fuwai Hospital
• ClinicalTrials.gov Identifier: NCT01060189
• Other Study ID Numbers: UTI Pilot Study
• First Posted: Feb 2, 2010
• Last Update Posted: Feb 5, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by SHI Jia, Associated Professor and Vice Chair of department of anesthesiology, Fuwai Hospital, NCCD, PUMC & CAMS, Chinese Academy of Medical Sciences, Fuwai Hospital: ulinastatin; tranexamic acid; cardiac surgery procedures; hemostasis
• Additional relevant MeSH terms: Tranexamic Acid; Urinastatin

Study Results

No Results Posted as of Feb 5, 2019