Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Trial Description
| Title | Standard-dose versus high-dose prophylactic anticoagulation in critically ill medical patients at risk for thromboprophylaxis failure: a multicentre, parallel-group, double-blind, phase III, randomized controlled trial |
| Participants (P) | Adult medical patients requiring ICU admission for at least three days with a high risk of thromboprophylaxis failure and a low baseline risk for bleeding |
| Intervention (I) | In addition to the low-dose prophylaxis, the participants will receive a blinded study drug, either enoxaparin 4,000 IU (0.4 ml) or placebo (sodium chloride 0.9%, 0.4 ml). This study drug will be administered once daily by subcutaneous injection, 12 hours after the open-label enoxaparin SC, for 28 days or until ICU discharge, whichever comes first. |
| Control (C) | All participants will receive a daily open-label dose of enoxaparin 4,000 IU (0.4 ml) in a pre-filled syringe by subcutaneous injection for 28 days or until ICU discharge (whichever comes first) as part of usual care, regardless of their assignment to the intervention or placebo arm. |
| Outcome (O) | Compare the efficacy and safety of HD-PA (4,000 IU twice daily) and SD-PA (SD-PA, 4,000 IU once daily) at Day 28 in terms of the net clinical outcome, which is a composite of venous thrombosis, major bleeding, or mortality. Primary endpoint: The primary combined efficacy and safety outcome at Day 28 is the net clinical outcome, which is a composite of clinically relevant venous thrombosis (symptomatic isolated distal leg deep venous thrombosis (DVT), proximal leg DVT, pulmonary embolism (PE) [except subsegmental], extensive central venous catheter (CVC)-related DVT), major bleeding (as per the International Society on Thrombosis and Hemostasis (ISTH) definition), all-cause death. |
| Trial Design | HIPRO is a multicenter, prospective, randomized, double-blind, phase 3 trial designed to compare high-dose prophylactic anticoagulation (HD-PA) to standard dose of prophylactic anticoagulation (SD-PA) in a 1:1 ratio in adult patients admitted to the ICU with a high risk for thromboprophylaxis failure and a low baseline risk for bleeding. The primary combined efficacy and safety outcome is the net clinical outcome, assessed at day 28, defined as a composite of clinically relevant venous thrombosis, major bleeding, or all-cause death. |
| Sample Size | 606 |
| Trial duration | 42 months |
| Budget | 2.63 Mio € |
Trial team
| Sponsor | HUB (Erasme) |
| Chief Investigator | Prof. Dr. Vincent Labbé |
| External partners | CRO CHU Mondor – France (TBC) |
| Number of participating sites | 12 |
DOCUMENTS
References
Clinicaltrials.gov:
Webpage:
Funding scheme
