A Phase 4 interventional study of Atenativ in Antithrombin III Deficiency, sponsored by Vastra Gotaland Region. Withdrawn at 1 site in Sweden. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-26.
Sponsored by Vastra Gotaland Region · Phase 4, Interventional, and Supportive care
The study will be an open controlled pilot study of 6 patients with early-onset severe preeclampsia. Patients will receive Atenativ in addition to conventional therapy The patients will be followed up within the study until three days after delivery. Laboratory analyses and uterine and umbiliacal blood flow will be determined.
The study will be an open controlled pilot study of 6 patients with early-onset severe preeclampsia. Patients will receive Atenativ in addition to conventional therapy The patients will be followed up within the study until three days after delivery. In addition to conventional therapy, i.v. administration of Atenativ will be given in a dosage aimed to raise the plasma level of AT initially to 120% (1.2 kIU/L) The goal is to achieve and maintain plasma activity of about 100% during two weeks. The dose of Atenativ is based on the actual plasma level of AT measured 2 hours before the dose. During the first two days of treatment plasma samples will be drawn for the measurement of AT activity twice a day, once before and 12 hours after infusion in order to monitor the dosage. Thereafter and until study discontinuation AT will be measured once a day. The treatment will continue for two weeks if plasma AT III is below 100% (1.0 kIU/L).Uterine blood flow is measured before, during and after the AT infusion. Demographic data, medical history and other background data (age, weight, height, gestational week, smoker or not, gravidity, parity, previous hypertension, previous medication etc) will be recorded in order to ensure that the inclusion criteria are met and to verify patient identity and inclusion status. The week of gestation when the patient is included in the study as well as the week of gestation at delivery is recorded.
The type of delivery (vaginal or caesarean section as well as planned or acute) will also be recorded.. General haemostatic parameters are to be analyzed before start of treatment and then every day during treatment and thereafter at least twice a week. Special haemostatic parameters are Placental growth factor, S-Flt-1, VEGF and Syndecan-1. They will be sampled before start of treatment and during treatment once a week. The samples will be collected and frozen and not analyzed before the termination of the study.
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Inclusion Criteria:
Severe preeclampsia as defined by international criteria (1,2)
AT level \<0.8 kIE/L
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Exclusion Criteria:1. History of congenital AT deficiency 2. Severe preeclampsia with demand on acute delivery within 24 hours according to the investigators judgments 3. Concomitant administration of anticoagulants and platelet inhibitors within 2 weeks 4. Chronic renal disease 5. Diabetes melittus or gestational diabetes 6. Intrauterine fetal death 7. Participation in another clinical study 8. Multiple pregnancies
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During two weeks antithrombin concentrate(Atenativ) will be administered in order to maintain normal levels of antithrombin
Drug: Atenativ
intravenous transfusion
Also known as: antithrombin concentrate
Blood flow in uterin and umbilical artery
Time frame: up to day 14
fetal outcome
CTG, blood flow, Apgar score, birthweight
Time frame: at birth
bleeding complications
measurements of bleeding before and after placenta delivery
Time frame: during pregnancy and at delivery
Biomarkers of endothelial damage
S-Flt-1, VEGF,Syndecan-1
Time frame: up to day 14
Atenativ concentrate
amount needed to maintain normal antithrombin levels
Time frame: treatment during 2 weeks
Plan to share: Yes — extern monitoring by Gothia Forum
This study is withdrawn, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Vastra Gotaland Region