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Reducing Post Operative Bleeding Following Cabg (LATA)

Primary Purpose

Post CABG Bleeding

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Tranexamic Acid
saline
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post CABG Bleeding

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • primary isolated CABG

Exclusion Criteria:

  • patients who will have combined procedure
  • redo-surgery
  • bleeding diathesis (Haemophilia or platelet count ,100 x 109 L1)
  • renal impairment (Creatinine > 130umol/L)
  • known allergy to TA
  • recent (< 7 days before surgery) intake of anti-platelets (eg Aspirin, Clopidogrel, Ticlid) or heparin administration within 48 hours of operation

Sites / Locations

  • Pusat Perubatan University Malaya

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

IV & topical TA

IV tranexamic acid & Topical Saline

Arm Description

patients in this group will receive both intravenous & topical tranexamic acid

Outcomes

Primary Outcome Measures

chest drain output
chest drain output (in mls) following post CABG in the 1st hour and total drain output when the drain is removed.

Secondary Outcome Measures

Full Information

First Posted
May 2, 2012
Last Updated
May 17, 2012
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT01600599
Brief Title
Reducing Post Operative Bleeding Following Cabg
Acronym
LATA
Official Title
Efficacy in Controlling Bleeding Post-coronary Bypass Surgery Using Combination of Local Application of Tranexamic Acid and Intravenous Tranexamic Compared to Intravenous Tranexamic Acid Alone. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the efficacy of IV Tranexamic Acid and topical Tranexamic Acid to control post op bleeding following Coronary Artery Bypass Graft Surgery using Cardiopulmonary Bypass.
Detailed Description
Coagulopathy is a common problem after open heart surgery using cardiopulmonary bypass (CPB). Some bleeding is significant enough to require early re-exploration to control hemorrhage in 2-4% of patients.(1,2) In adults, excessive post-operative bleeding occurs in association with repeat operations, emergency procedures, female gender, small body mass index, older age, peripheral vascular disease, renal insufficiency ( creatinine > 1.8g/dL) , poor nutrition ( albumin < 4g/dL) and in patients who have experienced prolonged CPB durations. (3,4) Factors that contribute to coagulopathy after coronary artery bypass grafting (CABG) using CPB include thrombocytopenia, acquired platlet dysfunction, loss of clotting factors, free heparin and increased fibrinolysis. (5-7). Lemmer and Colleagues (8) found that extracorporeal circulation results in significant fibrinolysis, as reflected by increased concentrations of plasmin and fibrin degradation products (FDP), both of which have deleterious effects on platlet function. Fibrinolysis was found to be responsible for 25-45% of significant post-bypass bleeding. (9) Many antifibrinolytic agents have been used to reduce post-bypass bleeding. These include ε- Aminocaproic Acid (10), Aprotinin (11) and Tranexamic Acid (TA) (12). TA has been found to bind to lysine binding sites of plasmin and plasminogen. Saturation of these sites displaces plasminogen from the fibrin surface thus inhibiting fibrinolysis.(13). TA has been used both systemically and topically. Due to the natural barrier properties of the pericardium, which prevents the free diffusion of substances, experimental studies have shown that the local application of different medications in to the pericardial cavity can lead to desirable therapeutic effects without significant systemic absorption. (14-16) There has been a systemic review and meta-analysis study done looking at 8 trials (622 patients) using topical antifibrinolytic agents (aprotinin and tranexamic acid). No adverse effects were reported following usage of topical antifibrinolytics.(17) Topical TA has also been successfully used in controlling bleeding in bladder, gynaecological, oral, & oropharyngeal surgeries. (18-20) There has been no authors thus far who have compared application of intravenous TA to combination of application of intravenous TA and topical TA. This study is based on a hypothesis that the combination of intravenous (IV) TA and topical TA administration will significantly reduce the amount of post-op bleeding significantly following CABG using CPB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post CABG Bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV & topical TA
Arm Type
Active Comparator
Arm Description
patients in this group will receive both intravenous & topical tranexamic acid
Arm Title
IV tranexamic acid & Topical Saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
intravenous 1g and topical 1g
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
100mls of topical saline
Primary Outcome Measure Information:
Title
chest drain output
Description
chest drain output (in mls) following post CABG in the 1st hour and total drain output when the drain is removed.
Time Frame
4 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary isolated CABG Exclusion Criteria: patients who will have combined procedure redo-surgery bleeding diathesis (Haemophilia or platelet count ,100 x 109 L1) renal impairment (Creatinine > 130umol/L) known allergy to TA recent (< 7 days before surgery) intake of anti-platelets (eg Aspirin, Clopidogrel, Ticlid) or heparin administration within 48 hours of operation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
theevashini krishnasamy, MBChB, MRCS
Organizational Affiliation
University Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusat Perubatan University Malaya
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
59100
Country
Malaysia

12. IPD Sharing Statement

Citations:
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Reducing Post Operative Bleeding Following Cabg

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