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Clot Dissolving Treatment for Blood Clots in the Lungs

NCT00680628 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2022-10-12

Study results available
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Summary

The purpose of this study is to determine if tenecteplase plus enoxaparin is safe and effective in the treatment of patients with severe submassive pulmonary embolism.

Conditions

Interventions

DRUG

Tenecteplase + Enoxaparin

Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated. Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: \<60Kg=30mg; ≥60Kg to \<70Kg=35mg; ≥70Kg to \<80Kg=40mg; ≥80Kg to \<90Kg=45mg; ≥90Kg=50mg

DRUG

0.9% Saline + Enoxaparin

Enoxaparin: 1 mg/kg within 12 hours before receiving saline.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Jeffrey A Kline, MD · Carolinas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2012-05-31
Completion
2012-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00680628 on ClinicalTrials.gov