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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| butterfly needle with valve | Other | thromboelastography |
|
| Standard hypodermic needle | Other | thromboelastography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thromboelastography | Diagnostic Test | paired TEG analysis undertaken from participants with the two different needles |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asif Mahmood, MBChB,FRCA | University Hospital Leicester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Leicester | Leicester | LE1 5WW | United Kingdom |
De-identified data with all primary outcomes measures will be made available
From publication of paper, for as long as required
Data access requests will be reviewed by an external independent review panel. Requesters will be required to sign a data access agreement.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2017 | Jan 18, 2018 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: healthy volunteer consent | Nov 15, 2016 | Jan 18, 2018 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Pregnant volunteer consent | Jul 30, 2016 | Jan 18, 2018 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D051299 | Post-Dural Puncture Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D013916 | Thrombelastography |
| ID | Term |
|---|---|
| D001780 | Blood Coagulation Tests |
| D006403 | Hematologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| D009422 | Nervous System Diseases |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |