SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00878826

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Prophylactic Enoxaparin Dosing for Prevention of Venous Thromboembolism in Pregnancy.

Enoxaparin is a type of low molecular weight heparin (LMWH), or anticoagulant, used to prevent and treat blood clots. Formation of blood clots, or venous thromboemboli (VTE) in pregnancy can have dangerous and even life-threatening effects on the mother and fetus. Enoxaparin is the preferred medicine to prevent clotting in pregnant patients who are at risk for VTE, because it has been studied to be safe and effective in pregnancy without any harms to the fetus. Although this medication is routinely used and is recommended by several prominent medical groups, the optimal dosing for prevention of VTE is still unclear. The range of standardly prescribed dosing regimens of Enoxaparin includes 40mg daily and 1mg/kg daily, but these two dosing strategies have never been compared in a head to head fashion.

NCT00878826 Venous Thrombosis
MeSH: Thrombosis Thromboembolism Venous Thromboembolism Venous Thrombosis
HPO: Deep venous thrombosis Thromboembolism Venous thrombosis

1 Interventions

Name: Enoxaparin

Description: Drug: Enoxaparin 40 mg every morning until 36 weeks gestation. Drug: Enoxaparin 1 mg per kg every morning until 36 weeks gestation. Dose will increase at wt. increases. Drug: Enoxaparin dose taken by patient when enrolled until 36 weeks gestation.

Type: Drug

Enoxaparin 40 mg per day Enoxaparin 1 mg per kg daily Pre prescribed regimen of Enoxaparin


Primary Outcomes

Description: Goal peak anti-Xa level is 0.2 to 0.4 u/ml. We compared peak drug levels between different dosing arms.

Measure: Peak Anti-Xa Level

Time: One measurement per trimester of pregnancy, up to 36 weeks

Secondary Outcomes

Measure: Thromboembolic Events

Time: Enrollment through 6 weeks postpartum

Measure: Bleeding Events

Time: Enrollment through 6 weeks postpartum

Measure: Side Effect - Bruising

Time: Enrollment through 6 weeks postpartum

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 G20210A

Inclusion Criteria: 1. >18 years of age 2. Warrants prophylaxis against venous thromboembolism in pregnancy according to American College of Obstetrics and Gynecology Practice Bulletin 2000, reaffirmed in 2008: - history of idiopathic thrombosis - history of thrombosis related to pregnancy or oral contraceptive use - history of thrombosis accompanied by an underlying thrombophilia other than homozygous for the factor V Leiden mutation, heterozygous for both the factor V Leiden and the prothrombin G20210A mutation, or AT-III deficiency - without a history of thrombosis but who have an underlying thrombophilia and a strong family history of thrombosis - Known thrombophilia except for those listed above, with a history of adverse pregnancy outcome (APO) as defined by: ¡Ý3 pregnancy losses in the 1st trimester, ¡Ý2 pregnancy losses/stillbirth in 2nd trimester, ¡Ý1 pregnancy loss/intrauterine fetal demise (IUFD) in the 3rd trimester, intrauterine growth restriction (IUGR), abruptio placentae, or severe pre-Eclampsia prior to 34 weeks gestation. --- G20210A ---

Exclusion Criteria: 1. Need for therapeutic-level anticoagulation as determined by physician 2. Renal disease as defined by serum creatinine >1.0 3. Weight >90kg 4. Allergy to enoxaparin Inclusion Criteria: 1. >18 years of age 2. Warrants prophylaxis against venous thromboembolism in pregnancy according to American College of Obstetrics and Gynecology Practice Bulletin 2000, reaffirmed in 2008: - history of idiopathic thrombosis - history of thrombosis related to pregnancy or oral contraceptive use - history of thrombosis accompanied by an underlying thrombophilia other than homozygous for the factor V Leiden mutation, heterozygous for both the factor V Leiden and the prothrombin G20210A mutation, or AT-III deficiency - without a history of thrombosis but who have an underlying thrombophilia and a strong family history of thrombosis - Known thrombophilia except for those listed above, with a history of adverse pregnancy outcome (APO) as defined by: ¡Ý3 pregnancy losses in the 1st trimester, ¡Ý2 pregnancy losses/stillbirth in 2nd trimester, ¡Ý1 pregnancy loss/intrauterine fetal demise (IUFD) in the 3rd trimester, intrauterine growth restriction (IUGR), abruptio placentae, or severe pre-Eclampsia prior to 34 weeks gestation. --- G20210A ---



HPO Nodes


HPO:
Deep venous thrombosis
Genes 12
THBD F2 PIEZO1 PROC F5 PROS1 SERPIND1 PMM2 SERPINC1 F9 AKT1 PLAT
Thromboembolism
Genes 14
F2 JAK2 PRKAR1A ADA2 INHBA KCNQ1 EPOR HRG CBS SERPINC1 FCGR2C MMACHC PRDX1 PIGA
Venous thrombosis
Genes 74
MPL IL10 JAK2 TET2 IL12A EPOR MET PRSS1 USP8 PRSS2 SAA1 THBD PDE4D PRTN3 THPO HLA-B SPINK1 SH2B3 PDGFRA ERAP1 HLA-DPA1 CALR IL12A-AS1 HLA-DPB1 PIEZO1 CFTR TLR4 CTRC FGA CD55 FGB PRKAR1A AGGF1 CDH23 CPA1 SERPINC1 CASR CCR1 UBAC2 AKT1 PTPN22 PLAT C4A CTLA4 GNAQ IDH1 FGG IDH2 CTNNB1 ACVRL1 PTEN GDF2 FAS F2 HBB ENG F5 CBS SERPIND1 KLRC4 F9 PTH1R MEFV IL23R NOTCH1 PGM1 TP53 STAT4 KIF11 PROC SMAD4 PROS1 PMM2 PIGM