Venous Thromboembolism Prophylaxis Post Cesarean Section (PROCS)
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|ClinicalTrials.gov Identifier: NCT01321788|
Recruitment Status : Unknown
Verified February 2012 by Farjah Hassan AlGahtani, King Saud University.
Recruitment status was: Recruiting
First Posted : March 24, 2011
Last Update Posted : February 6, 2012
|Condition or disease||Intervention/treatment|
|Bleeding Venous Thromboembolism||Drug: TINZAPARIN Drug: PLACEBO|
This is a double blind- a randomized controlled study of prophylactic LMWH in women at low risk for VTE following a cesarean section procedure. The sample size is 300 patients, Eligible, consenting, and randomized participants will receive once-daily injections of study drug (4,500 IU Tinzaparin Sodium [Innohep®] within 12- to 24-hours postpartum and continue for two weeks versus Placebo in the other arm and follow for six (6) weeks postpartum.
On the day of hospital discharge, bilateral leg imaging with compression, leg ultrasounds, and pelvic vein imaging with MRV will be completed. The primary outcome will be adjudicated, while DVT will be documented on ultrasounds or MRV on the day of hospital discharge. Secondary outcomes will include symptomatic DVT and PE, death from PE, major and minor bleeding, and HIT during the six-week postpartum period. All outcomes will be adjudicated by an independent committee of experts blinded to study drug allocation.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Venous Thromboembolism Prophylaxis Post Cesarean Section(PRO-CS-Trial)|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||January 2013|
|Estimated Study Completion Date :||January 2013|
will receive the study drug Innohep ® for 14 days
Eligible women following cesarean section will randomly receive once-daily injections of study drug (4,500 IU tinzaparin sodium within 12 to 24 hours postpartum and continued for two (2) weeks postpartum.
Other Name: Innohep
The group that will receive placebo for 14 days
Eligible women following cesarean section will receive a once-daily injections of placebo within 12 to 24 hours postpartum and continued for two (2) weeks postpartum.
- Deep Vein Thrombosis [ Time Frame: 24 months ]The primary outcome will be adjudicated, while DVT will be documented on ultrasounds or MRV on the day of hospital discharge.
- symptomatic DVT and bleeding [ Time Frame: Symptomatic DVT ]. Secondary outcomes will include symptomatic DVT and PE, death from PE, major and minor bleeding, and HIT during the six-week postpartum period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321788
|Contact: FARJAH H ALGAHTANI, MDemail@example.com|
|Security Forces Hospital||Recruiting|
|Riyadh, Saudi Arabia|
|Contact: Farjah H AlGahtani, MD 0505805919 firstname.lastname@example.org|
|Contact: , Pharm|
|Principal Investigator: Farjah H AlGahtani, MD|
|Sub-Investigator: Hessa AlDohami, MD|
|Principal Investigator:||FARJAH H ALGAHTANI, MD||King Saud University|