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Efficacy and Safety for Different Regimen of VTE Pharmacoprophylaxis Among Severely Burn Patients

NCT ID: NCT05237726

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-05

Study Completion Date

2022-02-28

Brief Summary

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This study aims to assess the feasibility and safety of VTE prophylaxis for 3 modality regimens (Unfractionated heparin 5000 U SQ q8 hours, Enoxaparin 40 mg SQ q24 hours or Enoxaparin 30 mg SQ q12 hours) in adult patients (≥18 y/o) with severely burn injuries (BSA≥20%) by measuring the bleeding incidence and VTE events.

Detailed Description

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This is a pilot , randomized control trial-Open label, prospective trial in tertiary academic hospitals for patient admitted to burn ICU for at least 24 hours of injury or transferred from other hospital(s) within 7 days of injury. Each patient admitted meets the inclusion criteria will be randomize by block randomization to either receive heparin 5000 units S.C. TID, enoxaparin 40 mg S.C. OD, or Enoxaparin 30 mg S.C. BID. VTE prophylaxis should be started within 36 hours of injury, if the patient is transferred from another facility, VTE prophylaxis should be started immediately unless contraindicated. All patients should undergo diagnostic ultrasound at baseline ( before starting the prophylaxis) to assess any presence of DVT and as clinically indicated for clinical suspicion for VTE thereafter until discharge, an urgent spiral CTA chest will be requested on clinical suspicion for PE. Anti Xa factor will be monitored at day 3, and weekly thereafter until discharge unless there is active bleeding or high clinical suspicion for bleeding. Will follow-up patient until discharge from ICU, developed VTE requiring treatment (switch to treatment dose), developed HIT or death.

Conditions

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Burns

Keywords

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Severely burn BSA≥20% Enoxaparin Unfractionated Heparin VTE Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three groups randomized to receive DVT prophylaxis either enoxaparin 30 mg every 12 hours, enoxaparin 40 mg once daily and unfractionated heparin 5000 units every 8 hours
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Unfractionated Heparin (UFH) 5000 U q8 hours

Severely burn injuries (BSA≥20%) will receive Unfractionated Heparin (UFH) 5000 U q8 hours as pharmacological VTE prophylaxis

Group Type ACTIVE_COMPARATOR

Unfractionated heparin 5000 U q8 hours

Intervention Type DRUG

Severely burn injuries (BSA≥20%) will be assigned to 3 modality regimens of pharmacological VTE prophylaxis: Unfractionated heparin 5000 U SQ q8 hours, Enoxaparin 40 mg SQ q24 hours or Enoxaparin 30 mg SQ q12 hours.

Enoxaparin 40 mg q24 hours

Severely burn injuries (BSA≥20%) will receive Enoxaparin 40 mg q24 hours as pharmacological VTE prophylaxis

Group Type ACTIVE_COMPARATOR

Enoxaparin 40 mg q24 hours

Intervention Type DRUG

Severely burn injuries (BSA≥20%) will be assigned to 3 modality regimens of pharmacological VTE prophylaxis: Unfractionated heparin 5000 U SQ q8 hours, Enoxaparin 40 mg SQ q24 hours or Enoxaparin 30 mg SQ q12 hours.

Enoxaparin 30 mg q12 hours

Severely burn injuries (BSA≥20%) will receive Enoxaparin 30 mg q12 hours as pharmacological VTE prophylaxis

Group Type ACTIVE_COMPARATOR

Enoxaparin 30 mg q12 hours

Intervention Type DRUG

Severely burn injuries (BSA≥20%) will be assigned to 3 modality regimens of pharmacological VTE prophylaxis: Unfractionated heparin 5000 U SQ q8 hours, Enoxaparin 40 mg SQ q24 hours or Enoxaparin 30 mg SQ q12 hours.

Interventions

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Enoxaparin 40 mg q24 hours

Severely burn injuries (BSA≥20%) will be assigned to 3 modality regimens of pharmacological VTE prophylaxis: Unfractionated heparin 5000 U SQ q8 hours, Enoxaparin 40 mg SQ q24 hours or Enoxaparin 30 mg SQ q12 hours.

Intervention Type DRUG

Enoxaparin 30 mg q12 hours

Severely burn injuries (BSA≥20%) will be assigned to 3 modality regimens of pharmacological VTE prophylaxis: Unfractionated heparin 5000 U SQ q8 hours, Enoxaparin 40 mg SQ q24 hours or Enoxaparin 30 mg SQ q12 hours.

Intervention Type DRUG

Unfractionated heparin 5000 U q8 hours

Severely burn injuries (BSA≥20%) will be assigned to 3 modality regimens of pharmacological VTE prophylaxis: Unfractionated heparin 5000 U SQ q8 hours, Enoxaparin 40 mg SQ q24 hours or Enoxaparin 30 mg SQ q12 hours.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Burn ICU admitted adult patients, age ≥ 18 years old.
* Body Mass Index of 18.5 to \< 40 kg/m2.
* TBSA of 20% or more.

Exclusion Criteria

* VTE history.
* Death within 24 hours of injury.
* Burn injuries combined with trauma requiring withholding pharmacoprophylaxis more than 48 hours.
* Coagulopathy (INR \> 1.7, PTT\> 2 times upper normal limit, platelet \< 50k mm3)
* Patient with positive baseline US for VTE.
* Heparin induced thrombocytopenia (HIT).
* Active bleeding.
* Patients with CrCl of 30 ml/min or less.
* Patients using anticoagulation treatment dose for other indications.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Abdullah International Medical Research Center

OTHER

Sponsor Role lead

Responsible Party

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KHALID ALSULAIMAN

Dr. Khalid Al Sulaiman, Consultant, Critical Care Clinical Pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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King Abdulaziz Medical City

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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Al Sulaiman KA, Al-Ramahi G, Aljuhani O, Al-Joudi K, Alhujayri AK, Al-Shomer F, Silas J, Al Dabbagh T, Al Harbi S, AlDekhayel S, Eldali A, Alqahtani R, Vishwakarma R, Al-Dorzi HM. Comparison of the safety and efficacy for different regimens of pharmaco-prophylaxis among severely burned patients: a randomized controlled trial. Eur J Trauma Emerg Surg. 2024 Apr;50(2):567-579. doi: 10.1007/s00068-024-02443-9. Epub 2024 Jan 19.

Reference Type DERIVED
PMID: 38240791 (View on PubMed)

Other Identifiers

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RC18-400-R

Identifier Type: -

Identifier Source: org_study_id