Clot Dissolving Treatment for Blood Clots in the Lungs

This study has been terminated.
(PI changed institution and impossible to solve problem with contract's sites)
Sponsor:
Information provided by (Responsible Party):
Jeffrey Kline, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT00680628
First received: May 16, 2008
Last updated: July 22, 2014
Last verified: July 2014
Results First Received: October 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pulmonary Embolism
Interventions: Drug: Tenecteplase + Enoxaparin
Drug: 0.9% Saline + Enoxaparin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients enrolled from 8 hospitals from August 2008 until October, 2012. Genentech funded the study. Carolinas Medical Center was the prime contractor site and subcontracted 7 other hospitals.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The investigator relocated to a new institution in July 2012, which led to insoluble problems with the subcontracts that forced early study closure.

Reporting Groups
  Description
Placebo

Tenecteplase + Enoxaparin

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

Tenecteplase

Saline + Enoxaparin

0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline.


Participant Flow:   Overall Study
    Placebo     Tenecteplase  
STARTED     43     40  
COMPLETED     43     40  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
see manuscript

Reporting Groups
  Description
Placebo

Tenecteplase + Enoxaparin

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

Tenecteplase

Saline + Enoxaparin

0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline.

Total Total of all reporting groups

Baseline Measures
    Placebo     Tenecteplase     Total  
Number of Participants  
[units: participants]
  43     40     83  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     37     34     71  
>=65 years     6     6     12  
Age  
[units: years]
Mean ± Standard Deviation
  54  ± 14     57  ± 14     55  ± 14  
Gender  
[units: participants]
     
Female     19     20     39  
Male     24     20     44  
Region of Enrollment  
[units: participants]
     
United States     43     40     83  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With Cardiogenic Shock or Respiratory Failure From Pulmonary Embolism and Number of Patietnts With Major Hemorrhage   [ Time Frame: 1,2,3,4, and 5 days ]

2.  Primary:   Number With Functional Cardiopulmonary Limitations Assessed With a Composite Measurement (Six Minute Walk Distance, Right Ventricular Function and Quality of Life Score on the SF-36)   [ Time Frame: 90 days ]

3.  Primary:   Number With Recurrent Venous Thromboembolism and/or Severe Post-phlebitic Syndrome   [ Time Frame: 90 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jeffrey Kline
Organization: Indiana University School of Medicine
phone: 3172873004
e-mail: jefkline@iupui.edu


No publications provided


Responsible Party: Jeffrey Kline, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT00680628     History of Changes
Other Study ID Numbers: 01-08-01A
Study First Received: May 16, 2008
Results First Received: October 29, 2013
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration