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

NCT05237726 | Completed

• 1 other identifier: RC18-400-R
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Burns

Keywords

Severely burn; BSA≥20%; Enoxaparin; Unfractionated Heparin; VTE; Bleeding

Outcome Measures

Primary Outcomes (3)

• Incidence of bleeding events (major and minor)

  Daily assessment of major and minor Bleeding. Bleeding will classified into major and minor bleeding. Major bleeding defined as clinically overt bleeding associated with a fall ≥Hb 20g/L, transfusion of ≥2U PRBC or whole blood, retroperitoneal or intracranial bleeding or requiring urgent medical intervention. Minor bleeding defined as those not fulfilling the criteria of major or clinically significant bleeding.

  Through study completion, an average of 2 years

• Adverse effects in surgical outcomes (i.e. Graft loss, donor site morbidity, requirement of hemostatic intervention).

  Daily assessment of donor site and graft site bleeding/failure. Graft site bleeding defined as bleeding at skin graft recipient site that requires premature wound exploration ( before 3 days postoperatively), bed side or operating room intervention to stop bleeding ( stitching, hemostatic agent or cauterization) with or without blood transfusion. Donor site bleeding/hematoma is any bleeding leading to a drop in hemoglobin \> 2 grams, hemodynamic instability or bleeding requiring urgent transfusion. Graft failure due to hematoma that require re-grafting or more than 50% of the graft site. Enoxaparin should be held 12 hours and unfractionated heparin 3-4 hours before percutaneous tracheostomy OR epidural catheter if indicated.

  Through study completion, an average of 2 years

• Recruitment and consent rates

  To assess the recruitment and consent rate to evaluate trial feasibility

  Through study completion, an average of 2 years

Secondary Outcomes (5)

• Target anti Xa factor for enoxaparin or unfractionated heparin in severely burn patients.

  Through study completion, an average of 2 years

• Incidence of Heparin induced thrombocytopenia (HIT).

  Through study completion, an average of 2 years

• Number of days that patients stay in hospital

  Through study completion, an average of 2 years

• Number of patients died within intensive care unit stay

  Through study completion, an average of 2 years

• Incidence of VTE events (Symptomatic)

  Through study completion, an average of 2 years

Study Arms (3)

Unfractionated Heparin (UFH) 5000 U q8 hours

ACTIVE COMPARATOR

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

Drug: Unfractionated heparin 5000 U q8 hours

Enoxaparin 40 mg q24 hours

ACTIVE COMPARATOR

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

Drug: Enoxaparin 40 mg q24 hours

Enoxaparin 30 mg q12 hours

ACTIVE COMPARATOR

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

Drug: Enoxaparin 30 mg q12 hours

Interventions

Enoxaparin 40 mg q24 hours 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

Enoxaparin 30 mg q12 hours 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

Unfractionated heparin 5000 U q8 hours 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.

Unfractionated Heparin (UFH) 5000 U q8 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead

Study Sites (1)

King Abdulaziz Medical City

Riyadh, 11426, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 38240791 DERIVED

MeSH Terms

Conditions

Burns; Hemorrhage

Interventions

Enoxaparin; Heparin

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Khalid Al Sulaiman, Consultant, Critical Care Clinical Pharmacist

Model Details: 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

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: February 14, 2022
• Study Start: April 5, 2020
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)