- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03653429
Efficacy of Tranexamic Acid in Foot and Ankle Surgeries
Efficacy of Tranexamic Acid in Foot and Ankle Surgeries- a Randomized Controlled Trial.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
New York
-
New York, New York, Forente stater, 10029
- Icahn School of Medicine at Mount Sinai
-
New York, New York, Forente stater, 10029
- Ichan School of Medicine
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Ettore Vulcano, MD, Ichan School of Medicine
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GCO 17-1691
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .