- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04479579
Improved Adherence With Extended Venous Thromboembolism Prophylaxis After Major Cancer Surgery
Towards Improved Adherence With Extended Venous Thromboembolism Prophylaxis After Abdominal or Pelvic Major Cancer Surgery
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
All guidelines have embraced the concept of extended DVT prophylaxis after major abdominal or pelvic surgery for cancer, but the recommendation is consistently to use LMWH, which is more complicated than orally available prophylaxis, more expensive and has poor adherence.
The patients will be identified in the pre-operative admission or in post-operative orders as potentially eligible for extended prophylaxis. On the day of discharge a research assistant or a research nurse will approach the patient, provide information about the study and obtain written consent if the patient fulfills the eligibility criteria.
Each patient will be asked to take apixaban until postop day 29±1 and will be followed until postop day 90±3. The total duration of the study from first patient in to last patient out is expected to take 12 months.
At 1 week after discharge there is a telephone contact to ask about any side effects from apixaban or bleeding events or signs of thromboembolism and to answer any questions from the patient.
At postoperative Day +28-30 there is a telephone contact to ask about side effects, bleeding, signs of venous thromboembolism (VTE), until what date the patient has taken apixaban and estimate of missed doses using a standardized script. If the patient is still taking it, instruction will be given to discontinue. Self-reported modified Morisky Medication Adherence scale with 6 statements will be used At 90 days ±3 days there is the last telephone contact to ask about bleeding events or signs of VTE. The study is complete for the patient. At the time of Visit 4 the pharmacy that the patient uses will be contacted to provide dispensing record for apixaban, in order to verify that the patient filled the prescription.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Kontakter och platser
Studieorter
-
-
Ontario
-
Hamilton, Ontario, Kanada, L8L 2X2
- Thrombosis Service, HHS-General Hospital
-
Hamilton, Ontario, Kanada, L8V 1C3
- HHS-Juravinski Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patients of at least 18 years of age, discharged after hepato-biliary, colorectal or gynecology-oncology abdominal/pelvic surgery (laparoscopic or open) for cancer and considered at increased risk for VTE (e.g. previous history of VTE, residual cancer, slow mobilization, obesity, comorbidities).
- Written informed consent obtained.
Exclusion Criteria:
- Patient unable to take tablets, even if crushed.
- Active bleeding.
- Venous thromboembolism diagnosed during the hospitalization.
- Severe hepatic impairment (Child Pugh class C).
- Severe renal failure on dialysis or with calculated creatinine clearance <15 mL/min.
- Platelet count <50·109/L.
- Concomitant treatment with azole-antimycotics, e.g., ketoconazole, itraconazole, voriconazole, or posaconazole, and HIV protease inhibitors, e.g., ritonavir.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Apixaban
apixaban for extended prophylaxis against VTE after discharge
|
apixaban 2.5 milligram twice daily from discharge until postoperative day 29 +/- 1 day
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Filled prescription
Tidsram: 1 week
|
Percent of included patients that have filled their prescription for apixaban
|
1 week
|
|
At least 80% adherence
Tidsram: 30 days
|
Percent of patients with filled prescription that have at least 80% adherence
|
30 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Rate of Venous thromboembolism post prophylaxis
Tidsram: 2 months
|
The event rate of venous thromboembolism during the 2 months after planned prophylaxis
|
2 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Rate of Venous thromboembolism during prophylaxis
Tidsram: 30 days
|
Symptomatic, objectively verified deep vein thrombosis of pulmonary embolism during 1st month
|
30 days
|
|
Rate of Major bleeding during prophylaxis
Tidsram: 30 days
|
Major bleeding during 1st month
|
30 days
|
|
Rate of Clinically relevant non-major bleeding during prophylaxis
Tidsram: 30 days
|
Clinically relevant non-major bleeding during 1st month
|
30 days
|
|
Rate of Death during prophylaxis
Tidsram: 30 days
|
Death during 1st month
|
30 days
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Sam Schulman, MD, PhD, Dr.
Publikationer och användbara länkar
Allmänna publikationer
- Serrano PE, Parpia S, Valencia M, Simunovic M, Bhandari M, Levine M. Incidence of delayed venous thromboembolic events in patients undergoing abdominal and pelvic surgery for cancer: a systematic review and meta-analysis. ANZ J Surg. 2019 Oct;89(10):1217-1223. doi: 10.1111/ans.15290. Epub 2019 Jun 18.
- Serrano PE, Parpia S, Linkins LA, Elit L, Simunovic M, Ruo L, Bhandari M, Levine M. Venous Thromboembolic Events Following Major Pelvic and Abdominal Surgeries for Cancer: A Prospective Cohort Study. Ann Surg Oncol. 2018 Oct;25(11):3214-3221. doi: 10.1245/s10434-018-6671-7. Epub 2018 Jul 26.
- Schulman S, Carlson V, Serrano PE, Sne N, Kahnamoui K, Mithoowani S, Ikesaka R, Gross PL. Adherence to apixaban for extended thromboprophylaxis after major abdominal or pelvic surgery for cancer: A prospective cohort study. J Surg Oncol. 2022 Aug;126(2):386-393. doi: 10.1002/jso.26876. Epub 2022 Apr 1.
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 10768 (Registeridentifierare: Panama ID UMCG)
Plan för individuella deltagardata (IPD)
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