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PRA-QHLBJV24-0H1XZS

Blutgerinnung

  • M/F
  • 18 - 49 years old
  • Healthy

This clinical trial will research a possible new treatment that can counter the effects of medications called direct acting oral anticoagulants.

  • From September 2024
  • 7 to 8 days
  • 2 visits

€2092,- bis €2309,-

Very positive experience. You are very well guided through the proces step by step. 

Maura

Deelnemer ICON

Find out if you qualify for this trial

  • You are a healthy male or female
  • You are between 18 and 49 years old
  • You weigh more than 60 kg
  • Your Body Mass Index (BMI) is between 18.5 and 30 kg/m2

Good to know about this trial

  • Short period of stay 
  • The compound has previously been administered to humans.

 

Wie funktioniert es

Wie funktioniert es?

Weiter lesen

Study groups

Register without obligation for the group of your preference

THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH

Additional information

This clinical trial will research a possible new treatment that can counter the effects of medications called direct acting oral anticoagulants. These anticoagulants inhibit the formation of blood clots and reduce the chance of a blood vessel blockage which is important in some people who are prone to this kind of problem but because they reduce the ability of their blood to clot this can be a problem if they experience a bleed or need surgery urgently. This treatment is meant for patients using anticoagulants to restore the coagulation (blood clotting) when they are experiencing bleeding or need urgent surgery. 

WHO CAN PARTICIPATE?

Target group

  • You are a healthy male or female
  • You are at least 18 and at most 49 years old.
  • Your BMI (Body Mass Index) is between 18-30 kg/m2. Your BMI is the ratio between your body weight (in kg) and your length (in m) taken squared.
  • Your body weight is at least 60 kilos and at most 120 kilos.
  • You have not smoked in the 4 weeks prior to the first study compound administration.

As a female you can only participate if you are not pregnant, not breastfeeding and meet one of the following conditions from the inspection until 90 days after the last dose:

  • You use hormonal contraception (for example “the pill” or hormonal IUD);
  • You use a copper coil;
  • You have passed the menopause (no more periods for at least 12 months);
  • You have been sterilized or your male partner has been sterilized;
  • You are not sexually active according to your lifestyle;
  • You are only sexually active with a partner of the same sex.

​As a male you can only participate if you meet one of the following conditions:

  • You use a condom with your female partner;
  • You have been sterilized at least 3 months before the inspection or your female partner has been sterilized or has passed menopause (no more menstruations for at least 12 months);
  • You are not sexually active according to your lifestyle;
  • You are only sexually active with a partner of the same sex.

Note:

  • You cannot participate in the study if you have participated in another clinical study in the 30 days prior to the first compound administration in this clinical study (counting from the last compound administration in the previous study).
  • To determine if you are suitable to participate in this study, you will undergo a medical screening. Depending on availability, this can be performed in Groningen or in Utrecht.

WHAT IS THE COMPENSATION FOR THIS RESEARCH?

Compensation

  • You will receive a gross compensation of € 2309 for participation in group 1.
  • You will receive a gross compensation of € 2092 for participation in group21.

Travel expenses will be reimbursed based on the distance traveled (€ 0.21 net per kilometer) with a minimum of € 13 and a maximum of € 176.40 (840 kilometers) per round trip, regardless of the mode of transportation.

HOW LONG DOES THIS RESEARCH TAKE?

Period of stay and research

  • In group 1 of this trial, every volunteer will stay in our clinic for 8 days (7 nights). After which you will come back for 1 short visit about a week after you leave the clinic.
  • In group 2 of this trial, every volunteer will stay in our clinic for 7 days (6 nights). After which you will come back for 1 short visit about a week after you leave the clinic. 
  • Approximately 3 weeks after your stay in our clinic, a follow up visit will take place. 
  • If needed, you might be asked back for extra follow-up visits every 12 weeks after your follow up visit until no antibodies against the study compound are found in the blood. You will receive extra compensation for this visit as it is not part of the standard participation. It is good to note that the extra follow up visits are not mandatory.

Veelgestelde vragen

Je mag maximaal 4 keer per jaar deelnemen aan een onderzoek. Tussen twee onderzoeken moeten minstens 30 dagen zitten. Voor sommige onderzoeken geldt een langere wachttijd.

Je kunt tijdens het onderzoek last krijgen van milde klachten als hoofdpijn of misselijkheid. Dat kan door het geneesmiddel komen. Maar het kan ook komen doordat je voor het onderzoek bijvoorbeeld nuchter moet blijven. Die bijwerkingen zijn vervelend, maar gelukkig niet gevaarlijk.

Voordat een geneesmiddel op mensen mag worden getest, is het al uitgebreid onderzocht in een laboratorium. Daardoor kunnen we goed voorspellen welke bijwerkingen je eventueel kunt krijgen en kunnen we je daarop voorbereiden. Het komt dus bijna nooit voor dat deelnemers last krijgen van onverwachte bijwerkingen. Een allergische reactie op het middel komt gemiddeld bijvoorbeeld één keer per jaar voor.

Je deelname aan geneesmiddelenonderzoek is altijd vrijwillig. Je mag dus op elk moment besluiten om te stoppen. Soms ben je genoodzaakt om te stoppen. Bijvoorbeeld vanwege familieomstandigheden, of als de arts besluit dat dat voor jouw gezondheid beter is. Als je stopt, bekijken we op welk deel van de vergoeding je recht hebt. Wel zo eerlijk!

Als je meedoet aan een onderzoek waarvoor je langer dan 10 dagen in het onderzoekscentrum verblijft, is het soms mogelijk om (in overleg) bezoek te ontvangen.

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