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NCT04517461: MVL-COAG
Coagulation and Vitamin K in Head and Neck Microvascular Free Flap Surgery
trial in Head and Neck Cancer in 40 participants. Completed in 1 October 2021.
15 September 2021
Quick facts
| Lead sponsor | Region Skane |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 40 |
| Start date | 15 September 2020 |
| Primary completion | 15 September 2021 |
| Estimated completion | 1 October 2021 |
| Sites | 1 location across Sweden |
Conditions studied
- Head and Neck Cancer — all drugs for Head and Neck Cancer →
- Intraoperative Complications — all drugs for Intraoperative Complications →
- Coagulation Disorder, Blood — all drugs for Coagulation Disorder, Blood →
- Vitamin K Deficiency — all drugs for Vitamin K Deficiency →
Sponsor
Region Skane — full company profile →
Who can join
18 and older, any sex, with Head and Neck Cancer or Intraoperative Complications. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
For patients with large head and neck tumors the recommended treatment, in many cases, is a combination of extensive surgery and postoperative radiotherapy. The surgical procedure involves resection of the tumor and reconstruction with a so called microvascular free flap, i.e. tissue transferred from for instance the arm or leg to the resection site. Complications of this complex procedure include, but are not limited to, bleeding and blood cloths (thrombosis) in the transferred tissue (free flap), which can cause very serious complications including need for further surgery and loss of the flap. Routine blood tests can measure parts of the system that regulates bleeding and the forming of blood clots, the so called coagulation system, but these tests don't cover the whole system. There are however more advanced instruments, such as ROTEM, rotational thromboelastometry, which provide a more global view of the hemostatic potential of whole blood. ROTEM is one of few more advanced assays that can be analyzed in emergency situations in major hospitals. Other more advanced coagulation assays are thrombin generation and measurements of specific coagulation factors, several of which are vitamin K dependent. Vitamin K is essential in the coagulation system and also involved in many other physiological processes. Deficiency of this vitamin is common, but not well studied in patients undergoing head an neck free flap surgery. The investigators plan to study ROTEM and other above mentioned coagulation parameters in patients undergoing major head and neck surgery including microvascular free flap reconstruction to assess if these parameters can help predict patients at risk for bleeding or flap thrombosis. Further on this could hopefully enable prevention of complications and improve treatment of coagulation complications that still occur.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04517461
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04517461 (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 Region Skane
- Last refreshed: 29 February 2024
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/NCT04517461.
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