- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07600905
Avatrombopag for Severe Thrombocytopenia After Liver Transplantation: A Retrospective Cohort Study
Effectiveness and Safety of Avatrombopag for Severe Post-Transplantation Thrombocytopenia in Liver Transplant Recipients: A Propensity-Score Matched Retrospective Cohort Study
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200032
- Zhongshan hospital, Fudan university
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria: (1) were aged 18 years or older; and (2) developed severe post transplantation thrombocytopenia (SPT), defined as a nadir platelet count below 30×10⁹/L within the first 7 days after LT.
Exclusion criteria: (1) use of avatrombopag within 4 weeks before LT; (2) second or subsequent LT; (3) death from surgical complications within 7 days after LT; (4) incomplete platelet measurement records; and (5) age younger than 18 years.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Arm 1: Avatrombopag Group / Arm 2: Control Group
Arm 1: Avatrombopag Group. Standard postoperative care with 40 mg orally once daily for 5 days, initiated when postoperative platelet count fell below 30×10⁹/L. Arm 2: Control Group. Standard postoperative care without avatrombopag |
40 mg orally once daily for 5 days, initiated when postoperative platelet count fell below 30×10⁹/L after liver transplatation
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
platelet rise rate
Tidsram: 30 days post-LT
|
The platelet rise rate was calculated as (postoperative peak platelet count - postoperative nadir platelet count) divided by (time to peak - time to nadir + 1), measured in ×10⁹/L/day.
|
30 days post-LT
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Absolute platelet increase (×10⁹ cells/L)
Tidsram: 30 days post-Liver transplatation
|
Postoperative peak minus postoperative nadir.
|
30 days post-Liver transplatation
|
|
Red blood cell transfusion volume (units)
Tidsram: 30 days post-Liver transplatation
|
Units of packed red blood cells transfused within 30 days after LT.
|
30 days post-Liver transplatation
|
|
Platelet transfusion volume (bags)
Tidsram: 30 days post-Liver transplatation
|
Bags of platelets transfused within 30 days after LT.
|
30 days post-Liver transplatation
|
|
Concomitant thrombopoietic agent use
Tidsram: 30 days post-Liver transplatation
|
Use of other thrombopoietic agents (e.g., recombinant human thrombopoietin), recorded as binary (yes/no).
|
30 days post-Liver transplatation
|
|
Infection (culture-proven + symptoms)
Tidsram: 30 days post-Liver transplatation
|
Presence of culture-confirmed infection with accompanying clinical symptoms within 30 days after LT.
|
30 days post-Liver transplatation
|
|
Mechanical ventilation requirement
Tidsram: 30 days post-Liver transplatation
|
Requirement for postoperative mechanical ventilation support.
|
30 days post-Liver transplatation
|
|
Renal replacement therapy requirement
Tidsram: 30 days post-Liver transplatation
|
Requirement for postoperative dialysis.
|
30 days post-Liver transplatation
|
|
Thrombotic events
Tidsram: 30 days post-Liver transplatation
|
Deep vein thrombosis or hepatic artery thrombosis.
|
30 days post-Liver transplatation
|
|
30-day mortality
Tidsram: 30 days post-Liver transplatation
|
All-cause death within 30 days after liver transplantation.
|
30 days post-Liver transplatation
|
Samarbetspartners och utredare
Sponsor
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
- B2026-303
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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