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Atenativ Effect on Uterine Blood Flow and Preeclampsia

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ClinicalTrials.gov Identifier: NCT02278575
Recruitment Status : Withdrawn (impossible to recruit participants due to organization changes)
First Posted : October 30, 2014
Last Update Posted : September 26, 2017
Sponsor:
Collaborator:
Octapharma
Information provided by (Responsible Party):
Margareta Hellgren, Vastra Gotaland Region

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Antithrombin III Deficiency Drug: Atenativ Phase 4

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Clinical Effect of Atenativ Treatment on Uterine Blood Flow and the Amount of Atenativ Needed to Maintain a Normal Antithrombin Lvels During Two Weeks in Early and Severe Preeclampsia
Study Start Date : January 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017


Arm Intervention/treatment
Consisting of treatment with Atenativ
During two weeks antithrombin concentrate(Atenativ) will be administered in order to maintain normal levels of antithrombin
Drug: Atenativ
intravenous transfusion
Other Name: antithrombin concentrate




Primary Outcome Measures :
  1. Blood flow in uterin and umbilical artery [ Time Frame: up to day 14 ]

Secondary Outcome Measures :
  1. fetal outcome [ Time Frame: at birth ]
    CTG, blood flow, Apgar score, birthweight

  2. bleeding complications [ Time Frame: during pregnancy and at delivery ]
    measurements of bleeding before and after placenta delivery


Other Outcome Measures:
  1. Biomarkers of endothelial damage [ Time Frame: up to day 14 ]
    S-Flt-1, VEGF,Syndecan-1

  2. Atenativ concentrate [ Time Frame: treatment during 2 weeks ]
    amount needed to maintain normal antithrombin levels



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pregnant woman in gestational week 23+0 - 29+0
  2. Severe preeclampsia as defined by international criteria (1,2)

    • Blood pressure >160/110 mmHg (measured twice 30 minutes apart). proteinuria (>5 .0 g/L per 24 hours or >3 + labstick in at least two random samples six hours apart) after 20th gestational week.
    • Blood pressure >140/90 mmHg and proteinuria >5.0 g/24 h.
    • preeclampsia ( blood pressure > 140/90 and proteinuria >0.3 g/24 h) with IUGR or subjective symptoms as epigastic pain (HELLP), headache, dizziness or visual disturbancies, oligouri < 600 ml/24 h, coagulation disturbancies.
  3. AT level <0.8 kIE/L

    -

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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Information from the National Library of Medicine

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): NCT02278575


Locations
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Sweden
Dept Obstetrics, Sahlgrenska University Hospital
Gothenburg, Sweden, 41685
Sponsors and Collaborators
Vastra Gotaland Region
Octapharma
Investigators
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Principal Investigator: Margareta Hellgren, MD,PhD,prof department Obstetrics, Sahlgrenska University Hospital

Publications of Results:

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Responsible Party: Margareta Hellgren, professor, MD, PhD, Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT02278575     History of Changes
Other Study ID Numbers: EudraCT 2012-005770-57
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: extern monitoring by Gothia Forum
Keywords provided by Margareta Hellgren, Vastra Gotaland Region:
antithrombin, Atenativ, preeclampsia, blood flow.
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Antithrombin III Deficiency
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Blood Protein Disorders
Thrombophilia
Genetic Diseases, Inborn
Antithrombins
Antithrombin III
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants