Thromboprophylaxis in Critically Ill Patients

Status Terminated

Clinical Trial Summary

Intensive care patients are at high risk to develop deep venous thrombosis and pulmonary embolism. Despite anticoagulation with heparin 7% of ICU patients suffer from this serious complication. Optimal regimens for prevention of VTE have been established in medical patients only and are not known for ICU patients.

It was therefore the aim of this study to compare the bioavailability of a low molecular weight heparin in ICU patients and in medical patients. Furthermore, we looked wether a 50% dose increase resulted in better bioavailability of this drug.

Clinical Trial Description

Background: The optimal dose regimen of low molecular weight heparins (LMWH) for thromboprophylaxis in critically ill patients is unknown.

Objectives: We performed a prospective, randomized study to determine anti-Xa activities following subcutaneous administration of 5000 IU or 7500 IU dalteparin for thromboprophylaxis in ICU patients compared with medical patients receiving the standard dose of 5000 IU.

Patients and Methods: Twenty-five ICU patients received 7500 IU (group 1) and 29 ICU patients received 5000 IU dalteparin subcutaneously (group 2) for thromboprophylaxis. Twenty-nine medical patients receiving 5000 IU dalteparin served as control group (group 3). ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00437697
Study type	Interventional
Source	Medical University of Vienna
Contact
Status	Terminated
Phase	Phase 4
Start date	April 2003
Completion date	April 2005

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05347550` - Examining the Benefit of Graduated Compression Stockings in the Prevention of vEnous Thromboembolism in Low-risk Surgical Patients	N/A
Enrolling by invitation	`NCT05794165` - Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism	Phase 2
Completed	`NCT02379806` - The SYMPTOMS - SYstematic Elderly Medical Patients Thromboprophylaxis: Efficacy on Symptomatic OutcoMeS - Study	Phase 3
Recruiting	`NCT03691753` - Safety and Efficacy Study of Fitaya Vena Cava Filter	N/A
Completed	`NCT02197416` - Safety of Dabigatran Etexilate in Blood Clot Prevention in Children	Phase 3
Recruiting	`NCT05378035` - DOAC in Chinese Patients With Atrial Fibrillation
Recruiting	`NCT05171075` - A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE	Phase 3
Completed	`NCT01895777` - Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)	Phase 3
Completed	`NCT05897697` - Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
Completed	`NCT04736420` - Replication of the EINSTEIN-DVT Anticoagulant Trial in Healthcare Claims Data
Completed	`NCT04736719` - Replication of the AMPLIFY Anticoagulant Trial in Healthcare Claims Data
Completed	`NCT04735523` - Replication of the RECOVER-II Anticoagulant Trial in Healthcare Claims Data
Completed	`NCT02912234` - Effect of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Participants	Phase 1
Completed	`NCT02746185` - Cancer Associated Thrombosis, a Pilot Treatment Study Using Rivaroxaban	Phase 3
Completed	`NCT02829957` - RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding	Phase 2/Phase 3
Completed	`NCT02334007` - Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery	Phase 1/Phase 2
Completed	`NCT02661568` - Description of Patients With Acute Venous Thromboembolism in the UK's Clinical Practice Research Datalink Linked With Hospital Episode Statistics Dataset (CPRD-HES)	N/A
Completed	`NCT02223260` - Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age	Phase 2
Completed	`NCT01976988` - Prospective Study on Preoperative Versus Postoperative Venous Thromboprophylaxis in Patients Undergoing Major Colorectal Surgery	Phase 3
Completed	`NCT01431456` - Safety of DAbigatran and RIvaroxaban Versus NAdroparin in the Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery	Phase 3