- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03653429
Efficacy of Tranexamic Acid in Foot and Ankle Surgeries
Efficacy of Tranexamic Acid in Foot and Ankle Surgeries- a Randomized Controlled Trial.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Approximately 20% of all foot and ankle fractures are open. Excellent operative field without measurable bleeding remain prerequisite of most orthopedic procedures. Increase blood loss can increase the risk of infection, hematoma formation and wound complications. Presence of blood in synovium not only has direct corrosive effects but also causes increased intra capsular pressure leading to capsular fibrosis culminating as ankyloses.
Tourniquets are employed to optimize surgical field visualization thereby limiting operative duration and improving technical precision. There are several unwanted effects that can arise from use of tourniquet like neurapraxia, vascular injury, post operative swelling etc. Hence there is a growing interest in achieving the same operative goals without the use of tourniquet.
Antifibrinolytics come to one's rescue to achieve a blood sparing effect. Its efficacy in reducing intra operative and post operative blood loss is well documented in cardiac surgery, hip and knee replacement surgery and spinal surgery. Tranexamic acid is a synthetic antifibrinolytic drug that competitively blocks the lysine-binding sites of plasminogen, plasmin and tissue plasminogen activator, thereby delaying fibrinolysis and blood clot degradation. It has been effectively used as IV, oral, topical as well as intra articular dosing. The effects of IV administration lasts 8-17 hours after the initial dose. Orthopedic surgeons have incorporated TXA into multiple elective surgeries as a means of reducing blood loss and transfusion requirements. Reduced bleeding translates to decreased incidence of wound hematoma and other complications.
Effectiveness of Tranexamic acid(TXA) is unknown in foot and ankle surgeries. The aim of this study is to not only evaluate effectiveness of intravenous TXA in reducing post operative blood loss during foot and ankle surgeries but also if it modulates to reduced wound complications and reduced narcotic consumption.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
New York
-
New York, New York, Forenede Stater, 10029
- Icahn School of Medicine at Mount Sinai
-
New York, New York, Forenede Stater, 10029
- Ichan School of Medicine
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- ASA (American Society of Anesthesiology) class I-IV
- age 8-75.
Exclusion Criteria:
- ASA class V
- morbid obesity
- patient refusal
- patients with known coagulopathy disorder
- renal insufficiency
- hepatic dysfunction
- serious cardiac disease
- an allergy to TXA or receiving antiplatelet and /or anticoagulant drugs will be excluded.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Tranexamic acid group
10mg/kg intravenous tranexamic
|
administered prior to surgical incision
|
|
Placebo komparator: Normal Saline group
10mg/kg intravenous normal saline
|
administered prior to surgical incision
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Total Estimated Blood Loss
Tidsramme: Average intra operative time 1-2 hours
|
Total estimated blood loss in millilitres during the surgery
|
Average intra operative time 1-2 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Wound Complications
Tidsramme: at first post-operative visit, 2 weeks post surgery
|
Number of participants with wound complications at first post-operative visit and at 2 weeks post surgery
|
at first post-operative visit, 2 weeks post surgery
|
|
Intra Operative Narcotic Consumption
Tidsramme: Average intra operative time 1-2 hours
|
Total intraoperative narcotic consumption in terms of morphine equivalents.(mme)
|
Average intra operative time 1-2 hours
|
|
Post Operative Narcotic Consumption
Tidsramme: 2 weeks after surgery
|
Post operative narcotic consumption, morphine mili equivalents
|
2 weeks after surgery
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Ettore Vulcano, MD, Ichan School of Medicine
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GCO 17-1691
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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