An interventional study of Thromboelastography in Post-Dural Puncture Headache and Low Pressure Headache, sponsored by University Hospitals, Leicester. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-05.
Sponsored by University Hospitals, Leicester · Not applicable, Interventional, and Other
The Department of Health recommends using equipment which prevents wrong route drug administration. However, the epidural blood patch requires equipment that connects to the intravenous and epidural route. To comply with these recommendations a non-Luer butterfly needle with one-way valve has been produced. The one-way valve and length of tubing has the potential to activate the clotting cascade. This could reduce the time clinicians have to utilise the blood in the syringe. Also any alteration in clotting could affect the therapeutic value of the epidural blood patch. The primary objective of this research was to determine if phlebotomy using this new 21G needle altered blood clotting, determined by thromboelastograph analysis, compared to a standard 21G hypodermic needle.
Ethical approval was gained from the Health Research Authority (North West - Greater Manchester South Research Ethics Committee, REC Reference Number: 16/NW/0570). After informed consent, we enrolled participants
122 studies on the registry are indexed under Post-Dural Puncture Headache; 27 are open to participants now.
This study's enrollment of 39 is below the median of 80 across 79 interventional studies indexed under Post-Dural Puncture Headache.
Browse Post-Dural Puncture Headache studies →University Hospitals, Leicester is the lead sponsor of 68 studies on the registry; 12 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.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
thromboelastography
Diagnostic Test: Thromboelastography
thromboelastography
Diagnostic Test: Thromboelastography
paired TEG analysis undertaken from participants with the two different needles
Reaction Time (R-time) (Minutes)
We will measure the thromboelastography (TEG) results of the patients blood with each needle. The TEG analysis will provide us with the R-time
Time frame: 1 hour
Maximum amplitude (millimetre) (MA)
We will measure the thromboelastography (TEG) results of the patients blood with each needle. The TEG analysis will provide us with the MA
Time frame: 1 hour
Lysis-30 (%) (LY30)
We will measure the thromboelastography (TEG) results of the patients blood with each needle. The TEG analysis will provide us with the LY30
Time frame: 1 hour
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified data with all primary outcomes measures will be made available
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: From publication of paper, for as long as required
Access criteria: Data access requests will be reviewed by an external independent review panel. Requesters will be required to sign a data access agreement.
Ran from Jan 2017 to primary completion in Apr 2017, 3 months.
Of 33 non-industry interventional studies with no phase under Post-Dural Puncture Headache, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 32. This study's 3 months is below that.
Counting every sponsor, half of 34 studies reached it within 9 months; a quarter within 4 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Post-Dural Puncture Headache →
University Hospitals, Leicester