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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Recruitment Status : Withdrawn (impossible to recruit participants due to organization changes)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

Tracking Information
First Submitted Date  ICMJE October 28, 2014
First Posted Date  ICMJE October 30, 2014
Last Update Posted Date September 26, 2017
Study Start Date  ICMJE January 2016
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2014)
Blood flow in uterin and umbilical artery [ Time Frame: up to day 14 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02278575 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2014)
  • fetal outcome [ Time Frame: at birth ]
    CTG, blood flow, Apgar score, birthweight
  • bleeding complications [ Time Frame: during pregnancy and at delivery ]
    measurements of bleeding before and after placenta delivery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 29, 2014)
  • Biomarkers of endothelial damage [ Time Frame: up to day 14 ]
    S-Flt-1, VEGF,Syndecan-1
  • Atenativ concentrate [ Time Frame: treatment during 2 weeks ]
    amount needed to maintain normal antithrombin levels
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Atenativ Effect on Uterine Blood Flow and Preeclampsia
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Antithrombin III Deficiency
Intervention  ICMJE Drug: Atenativ
intravenous transfusion
Other Name: antithrombin concentrate
Study Arms  ICMJE Consisting of treatment with Atenativ
During two weeks antithrombin concentrate(Atenativ) will be administered in order to maintain normal levels of antithrombin
Intervention: Drug: Atenativ
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 22, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2014)
6
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

-

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02278575
Other Study ID Numbers  ICMJE EudraCT 2012-005770-57
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: extern monitoring by Gothia Forum
Responsible Party Margareta Hellgren, Vastra Gotaland Region
Study Sponsor  ICMJE Vastra Gotaland Region
Collaborators  ICMJE Octapharma
Investigators  ICMJE
Principal Investigator: Margareta Hellgren, MD,PhD,prof department Obstetrics, Sahlgrenska University Hospital
PRS Account Vastra Gotaland Region
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP