Reducing Post Operative Bleeding Following Cabg

NCT ID: NCT01600599

Last Updated: 2012-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-05-31

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.

Conditions

Post CABG Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

IV & topical TA

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

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type: DRUG

intravenous 1g and topical 1g

IV tranexamic acid & Topical Saline

Group Type: PLACEBO_COMPARATOR

saline

Intervention Type: DRUG

100mls of topical saline

Interventions

Tranexamic Acid

intravenous 1g and topical 1g

Intervention Type: DRUG

saline

100mls of topical saline

Intervention Type: DRUG

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaya

OTHER

Sponsor Role: lead

Responsible Party

Dr Theevashini Krishnasamy, MBChB, MRCS

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

theevashini krishnasamy, MBChB, MRCS

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Locations

Pusat Perubatan University Malaya

Petaling Jaya, Selangor, Malaysia

Countries

Malaysia

References

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Other Identifiers

180880

Identifier Type: -

Identifier Source: org_study_id