Page last updated: 2024-11-05

tranexamic acid and Adverse Drug Event

tranexamic acid has been researched along with Adverse Drug Event in 10 studies

Tranexamic Acid: Antifibrinolytic hemostatic used in severe hemorrhage.

Research Excerpts

ExcerptRelevanceReference
"An open-label, extension clinical study was conducted to assess the safety of a novel, oral formulation of tranexamic acid (TA) in women with cyclic heavy menstrual bleeding."9.15Safety of tranexamic acid in women with heavy menstrual bleeding: an open-label extension study. ( Adomako, TL; Baker, J; Freeman, EW; Lukes, AS; Van Drie, D, 2011)
"An open-label, extension clinical study was conducted to assess the safety of a novel, oral formulation of tranexamic acid (TA) in women with cyclic heavy menstrual bleeding."5.15Safety of tranexamic acid in women with heavy menstrual bleeding: an open-label extension study. ( Adomako, TL; Baker, J; Freeman, EW; Lukes, AS; Van Drie, D, 2011)
" We proposed a systematic classification scheme using FDA-approved drug labeling to assess the DILI potential of drugs, which yielded a benchmark dataset with 287 drugs representing a wide range of therapeutic categories and daily dosage amounts."1.37FDA-approved drug labeling for the study of drug-induced liver injury. ( Chen, M; Fang, H; Liu, Z; Shi, Q; Tong, W; Vijay, V, 2011)

Research

Studies (10)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's4 (40.00)29.6817
2010's5 (50.00)24.3611
2020's1 (10.00)2.80

Authors

AuthorsStudies
Chen, M2
Vijay, V1
Shi, Q2
Liu, Z2
Fang, H2
Tong, W2
Ding, D1
Kelly, R1
El Hanache, H1
Verdaguer, M1
Collin, L1
Babin, M1
Favrelière, S1
Vidal Husser, S1
Maissiat, MH1
Hoppe, A1
Morisset, M1
Filipek, DR1
Zhang, Y1
Bai, Y1
Zhou, Y1
Yu, X1
Zhou, H1
Chen, G1
Henry, D1
Carless, P1
Fergusson, D1
Laupacis, A1
Lukes, AS1
Freeman, EW1
Van Drie, D1
Baker, J1
Adomako, TL1
Levy, JH1
Karkouti, K1
Beattie, WS1
Dattilo, KM1
McCluskey, SA1
Ghannam, M1
Hamdy, A1
Wijeysundera, DN1
Fedorko, L1
Yau, TM1
Lozano, M1
Basora, M1
Peidro, L1
Merino, I1
Segur, JM1
Pereira, A1
Salazar, F1
Cid, J1
Lozano, L1
Mazzara, R1
Macule, F1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery[NCT01728636]Phase 261 participants (Actual)Interventional2013-01-15Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Additional Blood Products Transfused

Total additional blood products (fresh frozen plasma, cryoprecipitate, and platelets) transfused in the perioperative period measured in units. (NCT01728636)
Timeframe: 24 hours after skin incision

InterventionUnits (Mean)
Tranexamic Acid1
Placebo2

Estimated Intraoperative Blood Loss

Estimated Intraoperative blood loss in milliliters (mLs) (NCT01728636)
Timeframe: Incision to skin closure (approximately 10 hours)

InterventionMilliliters (Mean)
Tranexamic Acid1550
Placebo1600

Post Operative Major Morbidity

Number of participants who experienced arterial or venous thromboembolism, neurologic complications (including stroke, seizure,and delirium), infections, and pulmonary renal or cardiac adverse outcomes (demand ischemia, myocardial infarction or new arrhythmia) before another operative procedure or hospital discharge. (NCT01728636)
Timeframe: Time of surgery to date of discharge from hospital (average 7 days)

InterventionParticipants (Count of Participants)
Tranexamic Acid9
Placebo9

Total Operating Room Time

Total operating room time from incision to closure of incision in minutes. (NCT01728636)
Timeframe: Minutes

InterventionMinutes (Median)
Tranexamic Acid602
Placebo576

Total Red Blood Cells Transfused in the Intraoperative Period

Total red blood cells transfused in the intraoperative period in (mL). Total RBC equal packed red blood cells and cell saver infusion. (NCT01728636)
Timeframe: Intraoperative period (approximately 12 hours)

Interventionmilliliters (Median)
Tranexamic Acid1140
Placebo1460

Total Tranexamic Acid Dose (mg)

Total milligrams of intravenous tranexamic acid administered during the surgical procedure. (NCT01728636)
Timeframe: Intraoperative period

Interventionmilligrams (Median)
Tranexamic Acid1408
Placebo0

Reviews

2 reviews available for tranexamic acid and Adverse Drug Event

ArticleYear
The safety and efficiency of intravenous administration of tranexamic acid in coronary artery bypass grafting (CABG): a meta-analysis of 28 randomized controlled trials.
    BMC anesthesiology, 2019, 06-14, Volume: 19, Issue:1

    Topics: Administration, Intravenous; Antifibrinolytic Agents; China; Coronary Artery Bypass; Drug-Related Si

2019
The safety of aprotinin and lysine-derived antifibrinolytic drugs in cardiac surgery: a meta-analysis.
    CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 2009, Jan-20, Volume: 180, Issue:2

    Topics: Adult; Aminocaproic Acid; Antifibrinolytic Agents; Aprotinin; Blood Loss, Surgical; Coronary Artery

2009

Trials

2 trials available for tranexamic acid and Adverse Drug Event

ArticleYear
Safety of tranexamic acid in women with heavy menstrual bleeding: an open-label extension study.
    Women's health (London, England), 2011, Volume: 7, Issue:5

    Topics: Adolescent; Adult; Antifibrinolytic Agents; Double-Blind Method; Drug-Related Side Effects and Adver

2011
Effectiveness and safety of tranexamic acid administration during total knee arthroplasty.
    Vox sanguinis, 2008, Volume: 95, Issue:1

    Topics: Aged; Aged, 80 and over; Antifibrinolytic Agents; Arthroplasty, Replacement, Knee; Blood Loss, Surgi

2008

Other Studies

6 other studies available for tranexamic acid and Adverse Drug Event

ArticleYear
FDA-approved drug labeling for the study of drug-induced liver injury.
    Drug discovery today, 2011, Volume: 16, Issue:15-16

    Topics: Animals; Benchmarking; Biomarkers, Pharmacological; Chemical and Drug Induced Liver Injury; Drug Des

2011
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
    PLoS computational biology, 2011, Volume: 7, Issue:12

    Topics: Animals; Anti-Infective Agents; Anti-Inflammatory Agents; Chemical and Drug Induced Liver Injury; Da

2011
Two Cases of Anaphylaxis to Tranexamic Acid Confirmed by Drug Provocation Test: What About Skin Tests?
    Journal of investigational allergology & clinical immunology, 2021, 07-26, Volume: 31, Issue:4

    Topics: Adolescent; Anaphylaxis; Bronchial Spasm; Drug Hypersensitivity; Drug-Related Side Effects and Adver

2021
Tranexamic Acid in Total Hip Arthoplasty: Management of Complications and Use.
    Medsurg nursing : official journal of the Academy of Medical-Surgical Nurses, 2017, Volume: 26, Issue:2

    Topics: Adult; Aged; Aged, 80 and over; Arthroplasty, Replacement, Hip; Drug Dosage Calculations; Drug-Relat

2017
Aprotinin versus tranexamic acid: the controversy continues.
    Transfusion, 2006, Volume: 46, Issue:3

    Topics: Adult; Antifibrinolytic Agents; Aprotinin; Blood Platelet Disorders; Blood Transfusion; Cardiac Surg

2006
A propensity score case-control comparison of aprotinin and tranexamic acid in high-transfusion-risk cardiac surgery.
    Transfusion, 2006, Volume: 46, Issue:3

    Topics: Adult; Antifibrinolytic Agents; Aprotinin; Blood Platelet Disorders; Blood Transfusion; Cardiac Surg

2006