- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01014403
Delayed Versus Early Enoxaparin Prophylaxis After Traumatic Brain Injury (TBI) (DEEP)
The Delayed vs Early Enoxaparin Prophylaxis (DEEP) Study After Traumatic Brain Injury: A Randomized, Double-Blinded, Placebo Controlled Pilot Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
We propose to conduct a placebo-controlled non-inferiority pilot study to evaluate the rate of worsening of intracranial injury patterns after initiation of enoxaparin in TBI patients. Patient enrollment will occur at ETMC, blinded re-reading of CTs will occur at PMH, and administrative/analytical support will occur at UTSW. The study design will be a double-blind, randomized controlled trial in the ETMC Surgical Intensive Care Unit (SICU) consisting of 40 patients per arm. The decision for 80 patients was resource-based, as this is a pilot study. Further, we anticipate the need to contact 3 patients in order to obtain 1 successful recruitment.
Each arm will consist of low-risk TBI patients (defined as patients with a subdural or epidural hematoma < 8mm, intraparenchymal contusion < 2 cm, and/or single contusion per lobe) who have had a CT scan of the head without contrast at 24 hours post-injury which documents a stable injury pattern. The severity of neurologic deficit will have no bearing on their suitability for participation, and will not be considered in inclusion/exclusion criteria. After documentation of a stable intracranial injury pattern at this time interval, patients will be randomized to receive either enoxaparin 30 mg SQ every 12 hours or placebo with each regimen being initiated at 24 hours post-injury. A follow-up CT scan of the brain without contrast will be obtained on all patients 48 hours post-injury (and 24 hours after the initiation of enoxaparin/placebo). An additional CT scan of the brain without contrast will be obtained on any patient who experiences an abrupt change in neurologic exam at any time between the initiation of enoxaparin/placebo and the end of the study's interventional period at 96 hours post-injury (this time frame was chosen as it is the earliest time point at which there is universal agreement among both of our group's practitioners that enoxaparin use is safe from the risks of TBI expansion). Any patient with a worsened CT scan will have their investigational treatment discontinued at that time. At 96 hours post-injury, the interventional portion of the study will end, data collection for the primary endpoint will cease, and all patients will be placed on enoxaparin for the remainder of their hospital stay as per local standards of care. Patient participation in the study will last from the time of injury to 96 hours post-injury for the interventional part of the study, and from 96 hours post-injury until discharge from ETMC for the observational portion. While this latter time frame is obviously extremely variable, it averages approximately one to two weeks. During both the interventional and observational time periods, patients will have Duplex ultrasonography of the lower extremities performed for an edematous extremity, CT-angiography of the chest for unexplained hypoxia or tachycardia, and ventilation-perfusion scanning for suspicion of PE in the presence of a contraindication to IV contrast.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Texas
-
Dallas, Texas, Forenede Stater, 75390
- UT-Southwestern Medical Center
-
Tyler, Texas, Forenede Stater, 75701
- East Texas Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
1. Male and female patients admitted to the ETMC SICU with TBI who speak English or Spanish.
Exclusion Criteria:
- Epidural or subdural hematoma > 8mm.
- Intraparenchymal contusion >2 cm
- Multiple contusions w/in one lobe
- Subarachnoid hemorrhage in basilar or supracellar cistern and positive CTA
- Increased TBI on 24 hr post-injury CT
- Spinal canal hematoma
- Nonoperative mgmt of American Association for the Surgery of Trauma (AAST) Grade IV or higher organ injury
- Gastrointestinal hemorrhage
- Ongoing bleeding from a pelvic fracture
- Anticipated open reduction of long bone or pelvic fracture within study period.
- Intracranial pressure (ICP) >20 mmHg
- Coagulopathy consisting of International Normalized Ratio (INR)>1.5 or platelet count <50,000
- Expect brain death/discharge in 48 hrs
- Pre-existing dialysis dependence
- Documented DVT at time of admission
- Prisoners
- Pregnancy
- Age <18 years
- Terminally ill patients
- Anticoagulant use at time of injury
- Inability to gain consent from patient or legal next-of-kin in instance of TBI, intoxication, or psychiatric diagnoses
- Documented history of heparin allergy
- Initial head CT >6 hours post-injury
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: enoxaparin 30 mg SQ q12 hours
Enoxaparin started at 24 hours post-injury and continued until 96 hours post-injury.
|
Enoxaparin 30 mg sq q 12 hours
|
Placebo komparator: placebo
vehicle administered sq q 12 hours
|
vehicle
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants With Worsening TBI Hemorrhage
Tidsramme: 24 hours after the start of treatment/48 hours after the time of injury
|
Worsening of TBI hemorrhage pattern on any scheduled or PRN CT scans after the initiation of treatment
|
24 hours after the start of treatment/48 hours after the time of injury
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Extracranial Hemorrhagic Complications
Tidsramme: prior to discharge
|
percentage of participants that have extracranial hemorrhagic complications
|
prior to discharge
|
Count of Participants With Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Tidsramme: prior to discharge
|
prior to discharge
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Herb A Phelan, MD, UT Southwestern Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Karsygdomme
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Embolisme og trombose
- Kraniocerebralt traume
- Traumer, nervesystemet
- Hjerneskader
- Sår og skader
- Hjerneskader, traumatiske
- Tromboemboli
- Venøs tromboembolisme
- Molekylære mekanismer for farmakologisk virkning
- Fibrinolytiske midler
- Fibrinmodulerende midler
- Antikoagulanter
- Enoxaparin
Andre undersøgelses-id-numre
- 082009-026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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