A Phase 4 interventional study of Unfractionated heparin and Double-legged cycle ergometer exercise in Blood Coagulation Disorder, sponsored by Kristian Karstoft. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-26.
Sponsored by Kristian Karstoft · Phase 4, Interventional, and Treatment
The aim of this project is to assess the influence of exercise on pharmacokinetics (PK) and pharmacodynamics (PD) of a single dose of subcutaneously (sc) administered unfractionated heparin (UFH). It is hypothesized that exercise will increase the systemic exposure (PK) and therefore the clinical effects (PD) of the sc administered UFH.
To assess this, healthy male volunteers will be included in a controlled, randomized, crossover study, where they, on four separate days, will have UFH injected sc in the thigh, followed by different exercise interventions (one per experimental day). Blood sampling, with the aim of assessing PK and PD will be performed during the following hours.
147 studies on the registry are indexed under Blood Coagulation Disorders; 15 are open to participants now.
This study's enrollment of 23 is below the median of 49 across 78 interventional studies indexed under Blood Coagulation Disorders.
Browse Blood Coagulation Disorders studies →Kristian Karstoft is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
15,000 units of unfractionated heparin will be administered in the thigh. No exercise will be performed afterwards.
Drug: Unfractionated heparin · Behavioral: No exercise
15,000 units of unfractionated heparin will be administered in the thigh. Double-legged cycle ergometer exercise will be performed for 1 hour afterwards
Drug: Unfractionated heparin · Behavioral: Double-legged cycle ergometer exercise
15,000 units of unfractionated heparin will be administered in the thigh. Single-legged cycle ergometer exercise in leg where unfractionated heparin injection is given will be performed for 1 hour afterwards
Drug: Unfractionated heparin · Behavioral: Single-legged cycle ergometer exercise, with unfractionated heparin injection in the exercising leg
15,000 units of unfractionated heparin will be administered in the thigh. Single-legged cycle ergometer exercise in contralateral leg to where unfractionated heparin injection is given will be performed for 1 hour afterwards
Drug: Unfractionated heparin · Behavioral: Single-legged cycle ergometer exercise, with unfractionated heparin injection in the non-exercising leg
15,000 units of unfractionated heparin administered in the thigh
One hour of double-leg cycle ergometer exercise
One hour of single-leg cycle ergometer exercise, after unfractionated heparin injection in the ipsilateral leg
One hour of single-leg cycle ergometer exercise, after unfractionated heparin injection in the ipsilateral leg
No exercise
Difference between interventions in change in incremental activated partial thromboplastin time (aPTT)
Time frame: Peak aPTT for 1-8 hours after unfractionated heparin (UFH) injection
Difference between interventions in change in incremental plasma heparin
Time frame: Peak plasma heparin for 1-8 hours after UFH injection
Difference between interventions in mean incremental aPTT
Time frame: 1-8 hours after UFH injection
Difference between interventions in mean incremental plasma heparin
Time frame: 1-8 hours after UFH injection
Difference between interventions in change in aPTT
Time frame: 4 hours after UFH injection
Difference between interventions in change in plasma heparin
Time frame: 4 hours after UFH injection
Difference between interventions in mean incremental natriuretic peptides
Time frame: 1-8 hours after UFH injection
Difference between interventions in mean incremental follistatin
Time frame: 1-8 hours after UFH injection
Ran from Sep 2023 to primary completion in Feb 2024, 4 months.
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Kristian Karstoft