Last reviewed · How we verify
NCT03861286
Haemostatic Markers in Cardiopulmonary Bypass
trial in Unfractionated Heparin in 30 participants. Completed in 18 July 2019.
18 July 2019
Quick facts
| Lead sponsor | Imperial College London |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 30 |
| Start date | 15 February 2019 |
| Primary completion | 18 July 2019 |
| Estimated completion | 18 July 2019 |
| Sites | 1 location across United Kingdom |
Conditions studied
- Unfractionated Heparin — all drugs for Unfractionated Heparin →
- Cardiopulmonary Bypass Surgery — all drugs for Cardiopulmonary Bypass Surgery →
Sponsor
Imperial College London
Who can join
18 and older, any sex, with Unfractionated Heparin or Cardiopulmonary Bypass Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is to understand the changes occurring in a blood clotting protein, von Willebrand factor (VWF), in patients undergoing cardiac surgery who receive the blood thinner called Heparin. These patients are given Heparin through their veins, to prevent blood clot formation as it passes through the heart bypass machine. At the end of the operation, the effect of Heparin is reversed by another drug, Protamine Sulphate. Heparin prevents blood clots forming mainly by inactivating thrombin, a crucial protein needed for blood clotting. This effect of Heparin is monitored through blood tests called the 'Anti Factor-Xa' and the 'APTT'. Heparin has another effect on clotting: it can block the attachment of special blood cell fragments called platelets to damaged blood vessels, but this effect is not usually measured. Following blood vessel injury, the large VWF sticks to the damaged surface and captures platelets to form a 'plug' which stops bleeding. The platelet plug is then stabilised by other clotting proteins. This stops blood loss and allows vessel repair underneath. Heparin blocks the ability of VWF to capture platelets at the site of blood vessel injury. The higher the dose of Heparin, the greater this blocking effect is. This secondary effect of Heparin cannot be readily monitored and may explain why bleeding complications occur in patients receiving Heparin despite the monitoring with blood tests used. This study will look at the blood levels of Heparin, VWF and platelets before, during and after surgery and how well VWF functions in the presence of heparin, including its ability to attach to platelets. The investigators will determine if all of the heparin related changes in blood clotting can be detected using a method that looks at all of the different steps in forming a blood clot.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03861286 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Imperial College London
- Last refreshed: 25 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03861286.
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