Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02616991
Other study ID # 2015-002741-64
Secondary ID 2015-A01262-47
Status Completed
Phase N/A
First received
Last updated
Start date June 4, 2016
Est. completion date April 2, 2021

Study information

Verified date April 2021
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether systematically performing computed tomography (CT) venography (i.e a CT acquisition of the pelvis and of the lower limbs, during the venous phase of opacification) in addition to thoracic CT angiography in women with suspected postpartum pulmonary embolism (PE) results in a gain in venous thromboembolism detection rate.


Description:

Pulmonary embolism (PE) remains a leading cause of maternal death during postpartum in developed countries; Thoracic computed tomography angiography (CTA) is the first-line diagnostic test for PE suspicion, but has a 20 to 35% rate of inconclusiveness during pregnancy and postpartum, 2 to 3 times higher than that of the general population. CT venography (CTV) consists in a delayed CT acquisition of the abdomen, pelvis and lower limbs, 3 minutes after starting contrast administration. It can be used for detecting deep venous thrombosis (DVT), the source of emboli in most PEs. The investigators hypothesized most postpartum PEs are due to pelvic vein thrombosis and that detecting such pelvic DVT by performing systematic CTV could increase the overall venous thromboembolism (VTE) detection.


Recruitment information / eligibility

Status Completed
Enrollment 125
Est. completion date April 2, 2021
Est. primary completion date December 4, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Women with clinically suspected pulmonary embolism (PE) during the first 6 weeks postpartum, without any sign of severe PE (shock, hypotension), referred for CT angiography - Absence of contraindication to iodinated contrast medium injection (Previous allergic reaction to iodinated contrast medium, renal insufficiency with creatine clearance less than 30mL/mn, uncontrolled hyperthyroidism) - Age > 18 years - Health insurance - Possibility to have 3-month follow-up - Obtention of written informed consent (ability to give consent) Exclusion Criteria: - Anticoagulation at therapeutic dosage for another reason than the suspicion of PE for more than 72 hours - New pregnancy (In case of any doubt after medical history review, ßHCG blood test must be realized to ensure patient's pregnancy status) - Contrast medium extravasation during injection - CTA or CTV not performed according to the study requirements

Study Design


Intervention

Procedure:
computed tomography venography
systematically performing computed tomography venography in addition to thoracic computed tomography angiography

Locations

Country Name City State
France Cochin Hospital Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Revel MP, Sanchez O, Dechoux S, Couchon S, Frija G, Cazejust J, Chatellier G, Meyer G. Contribution of indirect computed tomographic venography to the diagnosis of postpartum venous thromboembolism. J Thromb Haemost. 2008 Sep;6(9):1478-81. doi: 10.1111/j.1538-7836.2008.03078.x. Epub 2008 Jul 8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of detected venous thromboembolism (VTE) based on Computed Tomography Angiography (CTA) plus Computed Tomography Venography (CTV) VTE detection rate for readings based on CTA plus CTV as compared to readings based on CTA alone one day
Secondary Radiation doses due to CT venography 3 months
Secondary kappa coefficients assessing inter-readers agreement for CT venography readings 3 months
See also
  Status Clinical Trial Phase
Completed NCT01580085 - Obstructive Sleep Apnea in Pulmonary Embolism N/A
Enrolling by invitation NCT01558206 - Ultrasonography of Chest Versus Pulmonary Artery CT Angiography in Patients With Symptoms and Signs in Favor of PTE N/A
Completed NCT01513759 - Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy Phase 3
Completed NCT00968929 - Recombinant Streptokinase Versus Urokinase in Pulmonary Embolism in China (RESUPEC) Phase 4
Not yet recruiting NCT06206967 - Promotion of Active Lifestyle in Thromboembolism Patients N/A
Completed NCT03595891 - The Study of How Long Participants Stay in the Hospital After Receiving Apixaban for a Blood Clot in the Lung
Recruiting NCT04405869 - Thromboembolic Events in Severe COVID-19 Patients
Completed NCT01206751 - Multi-detector Computer Tomography Protocol Project: Chest Imaging Technique and Case Presentation N/A