Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00225108
Status:
COMPLETED
Last Update Posted:
2018-02-07
First Post:
2005-09-21
Brief Title:
The STOP CLOT Pilot Study Study of Low Molecular Weight Heparin in High Risk Cesarean Section
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
The Cesarean Section Thromboprophylaxis Pilot StudyA Randomized Open-Label Controlled Pilot Study of Prophylactic Low Molecular Weight Heparin in High Risk Postpartum Women Following Cesarean Section
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Venous thromboembolism VTE remains the most common cause of maternal death in the developed world VTE includes two conditions deep vein thrombosis DVT and pulmonary embolism PE DVT refers to a blood clot that has formed in a deep vein often in the legs andor pelvis and PE refers to the passage of these clots into the lungs which can be fatal VTE is up to 10 times more common in pregnant women than non-pregnant women of comparable age More than a third of pregnancy related VTE occur during the 6 weeks after delivery When compared with vaginal delivery cesarean delivery further increases the risk of pregnancy associated VTE by three-fold
A medication called low molecular weight heparin is sometimes prescribed during pregnancy and after delivery to prevent VTE However clinical practice varies because there hasnt been adequate research to determine that this medication is safe and effective at preventing VTE during this time The potential benefits of the medication must also be weighed against its cost and possible side effects
The researchers are conducting a study that will assess the effectiveness and safety of low molecular weight heparin in women who are at moderate to high risk of VTE after a cesarean section They will monitor these women to determine if those who received the medication have fewer blood clots Participants will also be monitored closely for any side effects
A medication called low molecular weight heparin is sometimes prescribed during pregnancy and after delivery to prevent VTE However clinical practice varies because there hasnt been adequate research to determine that this medication is safe and effective at preventing VTE during this time The potential benefits of the medication must also be weighed against its cost and possible side effects
The researchers are conducting a study that will assess the effectiveness and safety of low molecular weight heparin in women who are at moderate to high risk of VTE after a cesarean section They will monitor these women to determine if those who received the medication have fewer blood clots Participants will also be monitored closely for any side effects
Detailed Description:
BACKGROUND Venous thromboembolism VTE remains the most common cause of maternal mortality in the developed world VTE is up to 10 times more common in pregnant women than non-pregnant women of comparable age More than a third of pregnancy related VTE occur during the brief postpartum period 6 weeks When compared with vaginal delivery cesarean delivery further increases the risk of pregnancy associated VTE by three-fold Pregnancy associated VTE is unique in that isolated iliac vein thrombosis is more likely and long term morbidity post-phlebitic syndrome is common
There is an absence of randomized controlled trials RCTs of thromboprophylaxis after C-section to guide practice Many national societies have guidelines on thromboprophylaxis however these are not evidence based and compliance with these guidelines is poor Thromboprophylaxis may be associated with adverse effects bleeding heparin induced thrombocytopenia skin reactions inconvenience and cost It is critical that the efficacy and safety of thromboprophylaxis following cesarean delivery be assessed in well designed and conducted randomized trials
OBJECTIVES We are conducting a randomized double-blind placebo-controlled pilot study The pilot study seeks to answer the question Is a randomized double-blind placebo-controlled multicentre trial of low molecular weight heparin thromboprophylaxis feasible in moderate to high risk women post cesarean section with DVT detected by pelvic vein MRV or leg vein leg compression ultrasound imaging Our ultimate goal is to determine
1 Is LMWH effective in preventing postpartum DVT following cesarean section in women at moderate to high risk of VTE
2 Is LMWH safe in preventing postpartum DVT following cesarean section in women at moderate to high risk of VTE
3 Is LMWH cost effective in preventing postpartum DVT following cesarean section in women at moderate to high risk of VTE
STUDY DESIGN We propose a randomized double-blind placebo-controlled pilot study of prophylactic LMWH in women at moderate to high risk for VTE following cesarean section Eligible consenting and randomized participants will receive once-daily injections of study drug 4500 IU tinzaparin sodium Innohep or placebo within 6 to 24 hours postpartum and continue until 3 to 7 days 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 DVT 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 HIT during the six week postpartum period All outcomes will be adjudicated by an independent committee of experts blinded to study drug allocation
With a sample size of 134 patients we will have over 80 power to detect a 50 relative risk reduction in the primary outcome event rate and a large enough sample to determine the feasibility objectives of the pilot study ie obtain a precise estimate of the primary outcome event rate DVT a precise estimate of the multicentre recruitment rate feasibility and acceptability of blinded study drug and placebo administration feasibility of obtaining local study centre MRV and central interpretation of MRV and a preliminary relative risk reduction estimate with study drug compared to placebo to inform final study sample size determination
RELEVANCE Maternal mortality is a devastating outcome with far reaching emotional and societal implications Evidence to guide thromboprophylaxis in women at risk for the number 1 cause of maternal mortality is required
There is an absence of randomized controlled trials RCTs of thromboprophylaxis after C-section to guide practice Many national societies have guidelines on thromboprophylaxis however these are not evidence based and compliance with these guidelines is poor Thromboprophylaxis may be associated with adverse effects bleeding heparin induced thrombocytopenia skin reactions inconvenience and cost It is critical that the efficacy and safety of thromboprophylaxis following cesarean delivery be assessed in well designed and conducted randomized trials
OBJECTIVES We are conducting a randomized double-blind placebo-controlled pilot study The pilot study seeks to answer the question Is a randomized double-blind placebo-controlled multicentre trial of low molecular weight heparin thromboprophylaxis feasible in moderate to high risk women post cesarean section with DVT detected by pelvic vein MRV or leg vein leg compression ultrasound imaging Our ultimate goal is to determine
1 Is LMWH effective in preventing postpartum DVT following cesarean section in women at moderate to high risk of VTE
2 Is LMWH safe in preventing postpartum DVT following cesarean section in women at moderate to high risk of VTE
3 Is LMWH cost effective in preventing postpartum DVT following cesarean section in women at moderate to high risk of VTE
STUDY DESIGN We propose a randomized double-blind placebo-controlled pilot study of prophylactic LMWH in women at moderate to high risk for VTE following cesarean section Eligible consenting and randomized participants will receive once-daily injections of study drug 4500 IU tinzaparin sodium Innohep or placebo within 6 to 24 hours postpartum and continue until 3 to 7 days 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 DVT 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 HIT during the six week postpartum period All outcomes will be adjudicated by an independent committee of experts blinded to study drug allocation
With a sample size of 134 patients we will have over 80 power to detect a 50 relative risk reduction in the primary outcome event rate and a large enough sample to determine the feasibility objectives of the pilot study ie obtain a precise estimate of the primary outcome event rate DVT a precise estimate of the multicentre recruitment rate feasibility and acceptability of blinded study drug and placebo administration feasibility of obtaining local study centre MRV and central interpretation of MRV and a preliminary relative risk reduction estimate with study drug compared to placebo to inform final study sample size determination
RELEVANCE Maternal mortality is a devastating outcome with far reaching emotional and societal implications Evidence to guide thromboprophylaxis in women at risk for the number 1 cause of maternal mortality is required
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None