NCT01600599

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

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

January 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
Last Updated

May 18, 2012

Status Verified

May 1, 2012

Enrollment Period

1.2 years

First QC Date

May 2, 2012

Last Update Submit

May 17, 2012

Conditions

Post CABG Bleeding

Outcome Measures

Primary Outcomes (1)

  • chest drain output

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

    4 days

Study Arms (2)

IV & topical TA

ACTIVE COMPARATOR

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

Drug: Tranexamic Acid

IV tranexamic acid & Topical Saline

PLACEBO COMPARATOR
Drug: saline

Interventions

Tranexamic AcidDRUG

intravenous 1g and topical 1g

IV & topical TA
salineDRUG

100mls of topical saline

IV tranexamic acid & Topical Saline

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • primary isolated CABG

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusat Perubatan University Malaya

Petaling Jaya, Selangor, 59100, Malaysia

Location

Related Publications (21)

  • Munoz JJ, Birkmeyer NJ, Dacey LJ, Birkmeyer JD, Charlesworth DC, Johnson ER, Lahey SJ, Norotsky M, Quinn RD, Westbrook BM, O'Connor GT. Trends in rates of reexploration for hemorrhage after coronary artery bypass surgery. Northern New England Cardiovascular Disease Study Group. Ann Thorac Surg. 1999 Oct;68(4):1321-5. doi: 10.1016/s0003-4975(99)00728-6.

    PMID: 10543500BACKGROUND

  • Moulton MJ, Creswell LL, Mackey ME, Cox JL, Rosenbloom M. Reexploration for bleeding is a risk factor for adverse outcomes after cardiac operations. J Thorac Cardiovasc Surg. 1996 May;111(5):1037-46. doi: 10.1016/s0022-5223(96)70380-x.

    PMID: 8622301BACKGROUND

  • Magovern JA, Sakert T, Benckart DH, Burkholder JA, Liebler GA, Magovern GJ Sr, Magovern GJ Jr. A model for predicting transfusion after coronary artery bypass grafting. Ann Thorac Surg. 1996 Jan;61(1):27-32. doi: 10.1016/0003-4975(95)00808-X.

    PMID: 8561579BACKGROUND

  • Despotis GJ, Filos KS, Zoys TN, Hogue CW Jr, Spitznagel E, Lappas DG. Factors associated with excessive postoperative blood loss and hemostatic transfusion requirements: a multivariate analysis in cardiac surgical patients. Anesth Analg. 1996 Jan;82(1):13-21. doi: 10.1097/00000539-199601000-00004.

    PMID: 8712388BACKGROUND

  • Kucuk O, Kwaan HC, Frederickson J, Wade L, Green D. Increased fibrinolytic activity in patients undergoing cardiopulmonary bypass operation. Am J Hematol. 1986 Nov;23(3):223-9. doi: 10.1002/ajh.2830230306.

    PMID: 3766524BACKGROUND

  • Harker LA, Malpass TW, Branson HE, Hessel EA 2nd, Slichter SJ. Mechanism of abnormal bleeding in patients undergoing cardiopulmonary bypass: acquired transient platelet dysfunction associated with selective alpha-granule release. Blood. 1980 Nov;56(5):824-34. No abstract available.

    PMID: 6448643BACKGROUND

  • Despotis GJ, Santoro SA, Spitznagel E, Kater KM, Cox JL, Barnes P, Lappas DG. Prospective evaluation and clinical utility of on-site monitoring of coagulation in patients undergoing cardiac operation. J Thorac Cardiovasc Surg. 1994 Jan;107(1):271-9.

    PMID: 8283896BACKGROUND

  • Lemmer JH Jr, Stanford W, Bonney SL, Breen JF, Chomka EV, Eldredge WJ, Holt WW, Karp RB, Laub GW, Lipton MJ, et al. Aprotinin for coronary bypass operations: efficacy, safety, and influence on early saphenous vein graft patency. A multicenter, randomized, double-blind, placebo-controlled study. J Thorac Cardiovasc Surg. 1994 Feb;107(2):543-51; discussion 551-3.

    PMID: 7508070BACKGROUND

  • Kevy SV, Glickman RM, Bernhard WF, Diamond LK, Gross RE. The pathogenesis and control of the hemorrhagic defect in open heart surgery. Surg Gynecol Obstet. 1966 Aug;123(2):313-8. No abstract available.

    PMID: 5913482BACKGROUND

  • Daily PO, Lamphere JA, Dembitsky WP, Adamson RM, Dans NF. Effect of prophylactic epsilon-aminocaproic acid on blood loss and transfusion requirements in patients undergoing first-time coronary artery bypass grafting. A randomized, prospective, double-blind study. J Thorac Cardiovasc Surg. 1994 Jul;108(1):99-106; discussion 106-8.

    PMID: 8028387BACKGROUND

  • Cosgrove DM 3rd, Heric B, Lytle BW, Taylor PC, Novoa R, Golding LA, Stewart RW, McCarthy PM, Loop FD. Aprotinin therapy for reoperative myocardial revascularization: a placebo-controlled study. Ann Thorac Surg. 1992 Dec;54(6):1031-6; discussion 1036-8. doi: 10.1016/0003-4975(92)90066-d.

    PMID: 1280411BACKGROUND

  • Longstaff C. Studies on the mechanisms of action of aprotinin and tranexamic acid as plasmin inhibitors and antifibrinolytic agents. Blood Coagul Fibrinolysis. 1994 Aug;5(4):537-42.

    PMID: 7531000BACKGROUND

  • Baek SH, Hrabie JA, Keefer LK, Hou D, Fineberg N, Rhoades R, March KL. Augmentation of intrapericardial nitric oxide level by a prolonged-release nitric oxide donor reduces luminal narrowing after porcine coronary angioplasty. Circulation. 2002 Jun 11;105(23):2779-84. doi: 10.1161/01.cir.0000017432.19415.3e.

    PMID: 12057994BACKGROUND

  • Kolettis TM, Kazakos N, Katsouras CS, Niokou D, Pappa L, Koulouras V, Stefanou P, Seferiadis C, Malamou-Mitsi V, Michalis LK, Marselos M, Sideris DA. Intrapericardial drug delivery: pharmacologic properties and long-term safety in swine. Int J Cardiol. 2005 Mar 30;99(3):415-21. doi: 10.1016/j.ijcard.2004.03.004.

    PMID: 15771922BACKGROUND

  • Waxman S, Pulerwitz TC, Rowe KA, Quist WC, Verrier RL. Preclinical safety testing of percutaneous transatrial access to the normal pericardial space for local cardiac drug delivery and diagnostic sampling. Catheter Cardiovasc Interv. 2000 Apr;49(4):472-7. doi: 10.1002/(sici)1522-726x(200004)49:43.0.co;2-y.

    PMID: 10751782BACKGROUND

  • Abrishami A, Chung F, Wong J. Topical application of antifibrinolytic drugs for on-pump cardiac surgery: a systematic review and meta-analysis. Can J Anaesth. 2009 Mar;56(3):202-12. doi: 10.1007/s12630-008-9038-x. Epub 2009 Feb 12.

    PMID: 19247741BACKGROUND

  • Verstraete M. Clinical application of inhibitors of fibrinolysis. Drugs. 1985 Mar;29(3):236-61. doi: 10.2165/00003495-198529030-00003.

    PMID: 2580684BACKGROUND

  • Valsecchi A. [Further notes on the topical use of tranexamic acid in the treatment of gynecological hemorrhage]. Minerva Ginecol. 1980 Sep;32(9):825-30. No abstract available. Italian.

    PMID: 7219835BACKGROUND

  • Sindet-Pedersen S, Ramstrom G, Bernvil S, Blomback M. Hemostatic effect of tranexamic acid mouthwash in anticoagulant-treated patients undergoing oral surgery. N Engl J Med. 1989 Mar 30;320(13):840-3. doi: 10.1056/NEJM198903303201305.

    PMID: 2648144BACKGROUND

  • Abul-Azm A, Abdullah KM. Effect of topical tranexamic acid in open heart surgery. Eur J Anaesthesiol. 2006 May;23(5):380-4. doi: 10.1017/S0265021505001894. Epub 2006 Jan 27.

    PMID: 16438759BACKGROUND

  • De Bonis M, Cavaliere F, Alessandrini F, Lapenna E, Santarelli F, Moscato U, Schiavello R, Possati GF. Topical use of tranexamic acid in coronary artery bypass operations: a double-blind, prospective, randomized, placebo-controlled study. J Thorac Cardiovasc Surg. 2000 Mar;119(3):575-80. doi: 10.1016/s0022-5223(00)70139-5.

    PMID: 10694619BACKGROUND

MeSH Terms

Interventions

Tranexamic AcidSodium Chloride

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • theevashini krishnasamy, MBChB, MRCS

    University of Malaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 2, 2012

First Posted

May 17, 2012

Study Start

January 1, 2011

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

May 18, 2012

Record last verified: 2012-05

Locations

MY(1)